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STEP 1: Research Study Investigating How Well Semaglutide Works in People Suffering From Overweight or Obesity (STEP 1)

Primary Purpose

Metabolism and Nutrition Disorder, Overweight or Obesity

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Semaglutide

Placebo (semaglutide)

About this trial

This is an interventional treatment trial for Metabolism and Nutrition Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Main phase:

Male or female, age greater than or equal to 18 years at the time of signing informed consent
Body mass index (BMI) greater than or equal to 30.0 kg/sqm or greater than or equal to 27.0 kg/sqm with the presence of at least one of the following weight-related comorbidities (treated or untreated): hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease
History of at least one self-reported unsuccessful dietary effort to lose body weight

Extension phase:

Informed consent for the extension phase obtained before any trial related activities for the extension phase
On randomised treatment on the target dose at week 68, i.e. treated with 2.4 mg semaglutide once-weekly or semaglutide placebo

Exclusion Criteria:

Main phase:

Glycated haemoglobin (HbA1C) greater than or equal to 48 mmol/mol (6.5%) as measured by the central laboratory at screening
A self-reported change in body weight greater than 5 kg (11 lbs) within 90 days before screening irrespective of medical records

Extension phase:

Female who is pregnant or intends to become pregnant during the extension phase
Any disorder, unwillingness or inability, not covered by any of the other exclusion criteria, which in the investigator's opinion, might jeopardise the subject's compliance with the extension of the trial

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Semaglutide s.c. 2.4 mg once weekly

Semaglutide placebo

Arm Description

Participants will receive semaglutide for 68 weeks.

Participants will receive semaglutide matching placebo for 68 weeks.

Outcomes

Primary Outcome Measures

Change in Body Weight (%)

Change in body weight from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from both in-trial and on-treatment observation periods. In-trial observation period: the uninterrupted time interval from date of randomization (week 0) to date of last contact with trial site (week 75). On-treatment observation period: includes all time intervals in which participants are considered to be on treatment from the first (week 0) to last trial product administration (week 68), including 2 weeks of follow-up. It excludes any period of temporary treatment interruption. Temporary treatment interruption is defined as more than 2 consecutive missed doses (off-treatment period).

Participants Who Achieve 5 or More Percent Body Weight Reduction (Yes/no)

Number of participants who achieved weight loss more than or equal to 5% (yes/no) at week 68 are presented. The endpoint was evaluated based on the data from both in-trial and on-treatment observation periods. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75). On-treatment observation period: includes all time intervals in which participants are considered to be on treatment from the first (week 0) to last trial product administration (week 68), including 2 weeks of follow-up. It excludes any period of temporary treatment interruption.

Secondary Outcome Measures

Subjects Who Achieve 10 or More Percent Body Weight Reduction (Yes/no)

Number of participants who achieved weight loss more than or equal to (≥) 10% at week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from date of randomization (week 0) to date of last contact with trial site (week 75).

Participants Who Achieve 15 or More Percent Body Weight Reduction (Yes/no)

Number of participants who achieved more than or equal to (≥) 15% weight loss at week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).

Participants Who Achieve 20 or More Percent Body Weight Reduction (Yes/no)

Number of participants who achieved more than or equal to (≥) 20% weight loss at week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).

Change in Waist Circumference (cm)

Change in waist circumference from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to date of last contact with trial site (week 75).

Change in Systolic Blood Pressure (mmHg)

Change in systolic blood pressure from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to date of last contact with trial site (week 75).

Change in Short Form 36 (SF-36)

SF-36 is a 36-item patient-reported survey of patient health that measures the participant's overall health-related quality of life (HRQoL). SF-36v2™ questionnaire measured eight domains of functional health and well-being as well as two component summary scores (physical component summary and mental component summary). In the metric of norm-based scores, 50 and 10 corresponds to the mean and standard deviation, respectively, for the 2009 US general population. Change from week 0 in the domain scores and component summary scores were evaluated at week 68. A positive change score indicates an improvement since baseline. These endpoints were evaluated based on the data from in-trial observation period which is the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).

Change in Impact of Weight on Quality of Life-Lite for Clinical Trial (IWQoL-Lite for CT) Score

IWQoL-Lite for CT is a modified version of an instrument designed to assess weight-related quality of life. It is used to assess the impact of body weight changes on patients' physical and psychosocial functioning in three composite scores (physical function, physical and psychosocial) and a total score. The scores range between 0-100 where higher scores indicate a better quality of life. A positive change score indicates an improvement since baseline. These endpoints were evaluated based on the data from in-trial observation period which is the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).

Change in Body Weight (kg)

Change in body weight from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).

Change in Body Mass Index (BMI) (kg/m2)

Change in body mass index from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).

Change in HbA1C (%)

Change in glycosylated haemoglobin (HbA1c) from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).

Change in HbA1C (mmol/Mol)

Change in HbA1c from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).

Change in Fasting Plasma Glucose (FPG) (mg/dL)

Change in fasting plasma glucose from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).

Change in Fasting Serum Insulin (mIU/L) - Ratio to Baseline

Change in fasting serum insulin from week 0 to week 68 is presented as ratio to baseline. Fasting serum insulin was measured in milli-international units per milliliter (mIU/mL). The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).

Change in Diastolic Blood Pressure (mmHg)

Change in diastolic blood pressure from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).

Change in Total Cholesterol (mg/dL) - Ratio to Baseline

Change in fasting total cholesterol from baseline (week 0) to week 68 is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).

Change in High-density Lipoproteins (HDL) (mg/dL) - Ratio to Baseline

Change in fasting HDL from baseline (week 0) to week 68 is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).

Change in Low-density Lipoproteins (LDL) (mg/dL) - Ratio to Baseline

Change in fasting LDL from baseline (week 0) to week 68 is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).

Change in Very Low-density Lipoproteins (VLDL) (mg/dL) - Ratio to Baseline

Change in fasting VLDL from baseline (week 0) to week 68 is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).

Change in Free Fatty Acids (mg/dL) - Ratio to Baseline

Change in fasting free fatty acids from baseline (week 0) to week 68 is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).

Change in Triglycerides (mg/dL) - Ratio to Baseline

Change in fasting triglycerides from baseline (week 0) to week 68 is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).

Change in High Sensitivity C-Reactive Protein (hsCRP) - (mg/L) - Ratio to Baseline

Change in high sensitivity C-reactive protein from baseline (week 0) to week 68 is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).

Change in Plasminogen Activator Inhibitor-1 (PAI-1) Activity (AU/ml) - Ratio to Baseline

Change in plasminogen activator inhibitor-1 activity from baseline (week 0) to week 68 is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).

Change in Soluble Leptin Receptor (ng/mL) - Ratio to Baseline

Change in soluble leptin receptor from baseline (week 0) to week 68 is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).

Change in Leptin (ng/mL) - Ratio to Baseline

Change in leptin from baseline (week 0) to week 68 is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).

Change in Body Composition (Total Fat Mass) (%)

Change in body composition (total fat mass) from baseline (week 0) to week 68 is presented. Body composition was assessed using Dual Energy X-ray Absorpmetry (DEXA). The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).

Change in Body Composition (Total Fat Mass) (kg)

Change in Body Composition (Lean Body Mass) (%)

Change in body composition (lean body mass) from baseline (week 0) to week 68 is presented. Body composition was assessed using DEXA. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).

Change in Body Composition (Lean Body Mass) (kg)

Change in Body Composition (Visceral Fat Mass) (%)

Change in body composition (visceral fat mass) from baseline (week 0) to week 68 is presented. Body composition was assessed using DEXA. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).

Change in Body Composition (Visceral Fat Mass) (kg)

Change in Body Weight (%) - DEXA Subpopulation

Change in body weight from baseline (week 0) to week 68 is presented in DEXA subpopulation. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).

Change in Body Weight (kg) - DEXA Subpopulation

Participants Who Achieve "Responder Definition Value" (Yes/no) for SF-36 Physical Functioning Score

The observed number of participants experiencing a meaningful within participant improvement in SF-36 Physical function after 68 weeks was determined based on two different thresholds. The threshold of 4.3 is the default generic responder threshold defined in SF-36 manual for a general population. The threshold of 3.7 is specific for the population with overweight or obesity included in the study and calculated using patient global rating anchor questionnaires to reflect participants' own perspective based on FDA recommendations. In the reported data, "Yes" infers the number of participants who have achieved an improvement in score greater than or equal to the threshold and "No" infers number of participants who have not achieved an improvement in score greater than or equal to the threshold. The endpoint was evaluated based on the in-trial observation period which is the uninterrupted time interval from randomization (week 0) to last trial related subject-site contact (week 75).

Participants Who Achieve "Responder Definition Value" (Yes/no) for IWQoL-Lite for CT Physical Function Domain (5-items) Score

The observed number of participants experiencing a meaningful within participant improvement in IWQOL-Lite-CT physical function after 68 weeks was determined based on two different thresholds. The threshold of 20 was a preliminary responder threshold based on earlier studies. The threshold of 14.6 is specific for the population with overweight or obesity included in the study and calculated using patient global rating anchor questionnaires to reflect participants' own perspective based on FDA recommendations. In the reported data, "Yes" infers the number of participants who have achieved an improvement in score greater than or equal to the threshold and "No" infers the number of participants who have not achieved an improvement in score greater than or equal to the threshold. The endpoint was evaluated based on the in-trial observation period. In trial observation period: the uninterrupted time interval from randomization (week 0) to last trial related subject-site contact (week 75).

Number of Treatment Emergent Adverse Events (TEAEs)

An adverse event (AE) was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a product, whether or not considered related to the product. All AEs mentioned here are treatment emergent adverse events (TEAE) defined as an event for which the onset of the event occurs in the on-treatment period. The endpoint was evaluated based on the data from on-treatment observation period. On-treatment observation period: includes all time intervals in which participants are considered to be on treatment from the first (week 0) to last trial product administration (week 68), including 7 weeks of follow-up. It excludes any period of temporary treatment interruption. Temporary treatment interruption is defined as more than 7 consecutive missed doses (off-treatment period).

Number of Serious Adverse Events (SAEs)

A serious adverse event (SAE) is defined as any untoward medical occurrence that at any dose results in death, or is life-threatening, or requires inpatient hospitalization or causes prolongation of existing hospitalization results in persistent or significant disability/incapacity, or may have caused a congenital anomaly/birth defect, or requires intervention to prevent permanent impairment or damage. The SAEs occurred from week 0 to week 75 is presented. The endpoint was evaluated based on the data from on-treatment observation period. On-treatment observation period: includes all time intervals in which participants are considered to be on treatment from the first (week 0) to last trial product administration (week 68), including 7 weeks of follow-up. It excludes any period of temporary treatment interruption. Temporary treatment interruption is defined as more than 7 consecutive missed doses (off-treatment period).

Change in Pulse

Change in pulse from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from on-treatment observation period. On-treatment observation period: includes all time intervals in which participants are considered to be on treatment from the first (week 0) to last trial product administration (week 68) including 2 weeks of follow-up. It excludes any period of temporary treatment interruption. Temporary treatment interruption is defined as more than 2 consecutive missed doses (off-treatment period).

Change in Amylase - Ratio to Baseline

Change in amylase (measured as units per litre [U/L]) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment observation period. On-treatment observation period: includes all time intervals in which participants are considered to be on treatment from the first (week 0) to last trial product administration (week 68) including 2 weeks of follow-up. It excludes any period of temporary treatment interruption. Temporary treatment interruption is defined as more than 2 consecutive missed doses (off-treatment period).

Change in Lipase - Ratio to Baseline

Change in lipase (measured as units per litre [U/L]) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment observation period. On-treatment observation period: includes all time intervals in which participants are considered to be on treatment from the first (week 0) to last trial product administration (week 68) including 2 weeks of follow-up. It excludes any period of temporary treatment interruption. Temporary treatment interruption is defined as more than 2 consecutive missed doses (off-treatment period).

Change in Calcitonin - Ratio to Baseline

Change in calcitonin (measured as ng/L) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment observation period. On-treatment observation period: includes all time intervals in which participants are considered to be on treatment from the first (week 0) to last trial product administration (week 68) including 2 weeks of follow-up. It excludes any period of temporary treatment interruption. Temporary treatment interruption is defined as more than 2 consecutive missed doses (off-treatment period).

Full Information

NCT ID

NCT03548935

First Posted

May 25, 2018

Last Updated

November 18, 2021

Sponsor

Novo Nordisk A/S

1. Study Identification

Unique Protocol Identification Number

NCT03548935

Brief Title

STEP 1: Research Study Investigating How Well Semaglutide Works in People Suffering From Overweight or Obesity

Acronym

STEP 1

Official Title

Effect and Safety of Semaglutide 2.4 mg Once-weekly in Subjects With Overweight or Obesity

Study Type

Interventional

2. Study Status

Record Verification Date

November 2021

Overall Recruitment Status

Completed

Study Start Date

June 4, 2018 (Actual)

Primary Completion Date

March 30, 2020 (Actual)

Study Completion Date

March 5, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novo Nordisk A/S

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

This study will look at the change in participants' body weight from the start to the end of the study. The weight loss in participants taking semaglutide (a new medicine) will be compared to the weight loss of participants taking "dummy" medicine. In addition to taking the medicine, participants will have talks with study staff about healthy food choices, how to be more physically active and what you can do to lose weight. Participants will either get semaglutide or "dummy" medicine - which treatment participants get, is decided by chance. Participants will need to take 1 injection once a week. The study medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm. The study has two phases: A main phase and an extension phase.The main phase will last for about 1.5 years. Participants will have 15 clinic visits and 10 phone calls with the study doctor. Extension phase: Approximately 300 participants will continue in the extension phase in the following countries only: Canada, Germany, the UK and selected sites in the US and Japan. These participants will be in the study for about 2.5 years.They will not receive treatment, but will attend another 5 follow-up visits with the study doctor.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Metabolism and Nutrition Disorder, Overweight or Obesity

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Masking Description

Sponsor staff involved in the clinical trial is masked according to company standard procedures.

Allocation

Randomized

Enrollment

1961 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Semaglutide s.c. 2.4 mg once weekly

Arm Type

Experimental

Arm Description

Participants will receive semaglutide for 68 weeks.

Arm Title

Semaglutide placebo

Arm Type

Placebo Comparator

Arm Description

Participants will receive semaglutide matching placebo for 68 weeks.

Intervention Type

Drug

Intervention Name(s)

Semaglutide

Intervention Description

Participants will receive semaglutide subcutaneous (s.c.; under the skin) injection(s) once-weekly as well as diet and physical activity counselling for 68 weeks. Dose escalation of semaglutide will take place as follows: 0.25 mg from week 1 to 4, 0.5 mg from week 5 to 8, 1.0 mg from week 9 to 12, 1.7 mg from week 13 to 16 and 2.4 mg from week 17 to week 68.

Intervention Type

Drug

Intervention Name(s)

Placebo (semaglutide)

Intervention Description

Participants will receive semaglutide matching placebo s.c. injection(s) once-weekly as well as diet and physical activity counselling for 68 weeks.

Primary Outcome Measure Information:

Title

Change in Body Weight (%)

Description

Time Frame

Baseline (week 0) to week 68

Title

Participants Who Achieve 5 or More Percent Body Weight Reduction (Yes/no)

Description

Time Frame

After week 68

Secondary Outcome Measure Information:

Title

Subjects Who Achieve 10 or More Percent Body Weight Reduction (Yes/no)

Description

Time Frame

Week 68

Title

Participants Who Achieve 15 or More Percent Body Weight Reduction (Yes/no)

Description

Time Frame

Week 68

Title

Participants Who Achieve 20 or More Percent Body Weight Reduction (Yes/no)

Description

Time Frame

Week 68

Title

Change in Waist Circumference (cm)

Description

Time Frame

Baseline (week 0) to week 68

Title

Change in Systolic Blood Pressure (mmHg)

Description

Time Frame

Baseline (week 0) to week 68

Title

Change in Short Form 36 (SF-36)

Description

Time Frame

Baseline (week 0) to week 68

Title

Change in Impact of Weight on Quality of Life-Lite for Clinical Trial (IWQoL-Lite for CT) Score

Description

Time Frame

Baseline (week 0) to week 68

Title

Change in Body Weight (kg)

Description

Time Frame

Baseline (week 0) to week 68

Title

Change in Body Mass Index (BMI) (kg/m2)

Description

Time Frame

Baseline (week 0) to week 68

Title

Change in HbA1C (%)

Description

Time Frame

Baseline (week 0) to week 68

Title

Change in HbA1C (mmol/Mol)

Description

Time Frame

Baseline (week 0) to week 68

Title

Change in Fasting Plasma Glucose (FPG) (mg/dL)

Description

Time Frame

Baseline (week 0) to week 68

Title

Change in Fasting Serum Insulin (mIU/L) - Ratio to Baseline

Description

Time Frame

Baseline (week 0) to week 68

Title

Change in Diastolic Blood Pressure (mmHg)

Description

Time Frame

Baseline (week 0) to week 68

Title

Change in Total Cholesterol (mg/dL) - Ratio to Baseline

Description

Time Frame

Baseline (week 0) to week 68

Title

Change in High-density Lipoproteins (HDL) (mg/dL) - Ratio to Baseline

Description

Time Frame

Baseline (week 0) to week 68

Title

Change in Low-density Lipoproteins (LDL) (mg/dL) - Ratio to Baseline

Description

Time Frame

Baseline (week 0) to week 68

Title

Change in Very Low-density Lipoproteins (VLDL) (mg/dL) - Ratio to Baseline

Description

Time Frame

Baseline (week 0) to week 68

Title

Change in Free Fatty Acids (mg/dL) - Ratio to Baseline

Description

Time Frame

Baseline (week 0) to week 68

Title

Change in Triglycerides (mg/dL) - Ratio to Baseline

Description

Time Frame

Baseline (week 0) to week 68

Title

Change in High Sensitivity C-Reactive Protein (hsCRP) - (mg/L) - Ratio to Baseline

Description

Time Frame

Baseline (week 0) to week 68

Title

Change in Plasminogen Activator Inhibitor-1 (PAI-1) Activity (AU/ml) - Ratio to Baseline

Description

Time Frame

Baseline (week 0) to week 68

Title

Change in Soluble Leptin Receptor (ng/mL) - Ratio to Baseline

Description

Time Frame

Baseline (week 0) to week 68

Title

Change in Leptin (ng/mL) - Ratio to Baseline

Description

Time Frame

Baseline (week 0) to week 68

Title

Change in Body Composition (Total Fat Mass) (%)

Description

Time Frame

Baseline (week 0) to week 68

Title

Change in Body Composition (Total Fat Mass) (kg)

Description

Time Frame

Baseline (week 0) to week 68

Title

Change in Body Composition (Lean Body Mass) (%)

Description

Time Frame

Baseline (week 0) to week 68

Title

Change in Body Composition (Lean Body Mass) (kg)

Description

Time Frame

Baseline (week 0) to week 68

Title

Change in Body Composition (Visceral Fat Mass) (%)

Description

Time Frame

Baseline (week 0) to week 68

Title

Change in Body Composition (Visceral Fat Mass) (kg)

Description

Time Frame

Baseline (week 0) to week 68

Title

Change in Body Weight (%) - DEXA Subpopulation

Description

Time Frame

Baseline (week 0) to week 68

Title

Change in Body Weight (kg) - DEXA Subpopulation

Description

Time Frame

Baseline (week 0) to week 68

Title

Participants Who Achieve "Responder Definition Value" (Yes/no) for SF-36 Physical Functioning Score

Description

Time Frame

After week 68

Title

Participants Who Achieve "Responder Definition Value" (Yes/no) for IWQoL-Lite for CT Physical Function Domain (5-items) Score

Description

Time Frame

After week 68

Title

Number of Treatment Emergent Adverse Events (TEAEs)

Description

Time Frame

Baseline (week 0) to week 75

Title

Number of Serious Adverse Events (SAEs)

Description

Time Frame

Baseline (week 0) to week 75

Title

Change in Pulse

Description

Time Frame

Baseline (week 0) to week 68

Title

Change in Amylase - Ratio to Baseline

Description

Time Frame

Baseline (week 0) to week 68

Title

Change in Lipase - Ratio to Baseline

Description

Time Frame

Baseline (week 0) to week 68

Title

Change in Calcitonin - Ratio to Baseline

Description

Time Frame

Baseline (week 0) to week 68

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Main phase: Male or female, age greater than or equal to 18 years at the time of signing informed consent Body mass index (BMI) greater than or equal to 30.0 kg/sqm or greater than or equal to 27.0 kg/sqm with the presence of at least one of the following weight-related comorbidities (treated or untreated): hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease History of at least one self-reported unsuccessful dietary effort to lose body weight Extension phase: Informed consent for the extension phase obtained before any trial related activities for the extension phase On randomised treatment on the target dose at week 68, i.e. treated with 2.4 mg semaglutide once-weekly or semaglutide placebo Exclusion Criteria: Main phase: Glycated haemoglobin (HbA1C) greater than or equal to 48 mmol/mol (6.5%) as measured by the central laboratory at screening A self-reported change in body weight greater than 5 kg (11 lbs) within 90 days before screening irrespective of medical records Extension phase: Female who is pregnant or intends to become pregnant during the extension phase Any disorder, unwillingness or inability, not covered by any of the other exclusion criteria, which in the investigator's opinion, might jeopardise the subject's compliance with the extension of the trial

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Reporting Anchor and Disclosure (1452)

Organizational Affiliation

Novo Nordisk A/S

Official's Role

Study Director

Facility Information:

Facility Name

Novo Nordisk Investigational Site

City

Anniston

State/Province

Alabama

ZIP/Postal Code

36207

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Anaheim

State/Province

California

ZIP/Postal Code

92801

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Lomita

State/Province

California

ZIP/Postal Code

90717

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Spring Valley

State/Province

California

ZIP/Postal Code

91978

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Aurora

State/Province

Colorado

ZIP/Postal Code

80045

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Waterbury

State/Province

Connecticut

ZIP/Postal Code

06708

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Chiefland

State/Province

Florida

ZIP/Postal Code

32626

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Crystal River

State/Province

Florida

ZIP/Postal Code

34429

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32205

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32216

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Ocala

State/Province

Florida

ZIP/Postal Code

34470

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Panama City

State/Province

Florida

ZIP/Postal Code

32401

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Plantation

State/Province

Florida

ZIP/Postal Code

33324

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Ponte Vedra

State/Province

Florida

ZIP/Postal Code

32081

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Roswell

State/Province

Georgia

ZIP/Postal Code

30076

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60607

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60611

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46260

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Topeka

State/Province

Kansas

ZIP/Postal Code

66606

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40213

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Buckley

State/Province

Michigan

ZIP/Postal Code

49620

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Saint Peters

State/Province

Missouri

ZIP/Postal Code

63303

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Butte

State/Province

Montana

ZIP/Postal Code

59701

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68105

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Rochester

State/Province

New York

ZIP/Postal Code

14609

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Salisbury

State/Province

North Carolina

ZIP/Postal Code

28144

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Wilmington

State/Province

North Carolina

ZIP/Postal Code

28401

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

West Reading

State/Province

Pennsylvania

ZIP/Postal Code

19611

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29425

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Simpsonville

State/Province

South Carolina

ZIP/Postal Code

29681

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37212-1150

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Austin

State/Province

Texas

ZIP/Postal Code

78749

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Dallas

State/Province

Texas

ZIP/Postal Code

75226

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Dallas

State/Province

Texas

ZIP/Postal Code

75230

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Dallas

State/Province

Texas

ZIP/Postal Code

75234

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Round Rock

State/Province

Texas

ZIP/Postal Code

78681

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Bountiful

State/Province

Utah

ZIP/Postal Code

84010

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23294

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Renton

State/Province

Washington

ZIP/Postal Code

98057

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Caba

ZIP/Postal Code

C1093AAS

Country

Argentina

Facility Name

Novo Nordisk Investigational Site

City

Ciudad de Buenos Aires

ZIP/Postal Code

C1204AAD

Country

Argentina

Facility Name

Novo Nordisk Investigational Site

City

Corrientes

ZIP/Postal Code

3400

Country

Argentina

Facility Name

Novo Nordisk Investigational Site

City

Córdoba

ZIP/Postal Code

X5006IKK

Country

Argentina

Facility Name

Novo Nordisk Investigational Site

City

Santa Rosa

ZIP/Postal Code

6300

Country

Argentina

Facility Name

Novo Nordisk Investigational Site

City

Boussu

ZIP/Postal Code

7300

Country

Belgium

Facility Name

Novo Nordisk Investigational Site

City

Bruxelles

ZIP/Postal Code

1200

Country

Belgium

Facility Name

Novo Nordisk Investigational Site

City

Edegem

ZIP/Postal Code

2650

Country

Belgium

Facility Name

Novo Nordisk Investigational Site

City

Leuven

ZIP/Postal Code

3000

Country

Belgium

Facility Name

Novo Nordisk Investigational Site

City

Liège

ZIP/Postal Code

4000

Country

Belgium

Facility Name

Novo Nordisk Investigational Site

City

Plovdiv

ZIP/Postal Code

4002

Country

Bulgaria

Facility Name

Novo Nordisk Investigational Site

City

Sofia

ZIP/Postal Code

1431

Country

Bulgaria

Facility Name

Novo Nordisk Investigational Site

City

Sofia

ZIP/Postal Code

1606

Country

Bulgaria

Facility Name

Novo Nordisk Investigational Site

City

Sofia

ZIP/Postal Code

1797

Country

Bulgaria

Facility Name

Novo Nordisk Investigational Site

City

Edmonton

State/Province

Alberta

ZIP/Postal Code

T6H 2L4

Country

Canada

Facility Name

Novo Nordisk Investigational Site

City

Surrey

State/Province

British Columbia

ZIP/Postal Code

V3Z 2N6

Country

Canada

Facility Name

Novo Nordisk Investigational Site

City

Hamilton

State/Province

Ontario

ZIP/Postal Code

L8L 5G8

Country

Canada

Facility Name

Novo Nordisk Investigational Site

City

North York

State/Province

Ontario

ZIP/Postal Code

M2M 4J5

Country

Canada

Facility Name

Novo Nordisk Investigational Site

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M4P 1P2

Country

Canada

Facility Name

Novo Nordisk Investigational Site

City

Quebec

ZIP/Postal Code

G1V 4G2

Country

Canada

Facility Name

Novo Nordisk Investigational Site

City

Quebec

ZIP/Postal Code

G1V 4G5

Country

Canada

Facility Name

Novo Nordisk Investigational Site

City

Aarhus N

ZIP/Postal Code

8200

Country

Denmark

Facility Name

Novo Nordisk Investigational Site

City

Oulu

ZIP/Postal Code

90220

Country

Finland

Facility Name

Novo Nordisk Investigational Site

City

University Of Helsinki

ZIP/Postal Code

00014

Country

Finland

Facility Name

Novo Nordisk Investigational Site

City

Le Coudray

ZIP/Postal Code

28630

Country

France

Facility Name

Novo Nordisk Investigational Site

City

Narbonne

ZIP/Postal Code

11108

Country

France

Facility Name

Novo Nordisk Investigational Site

City

PARIS cedex 13

ZIP/Postal Code

75651

Country

France

Facility Name

Novo Nordisk Investigational Site

City

Paris

ZIP/Postal Code

75908

Country

France

Facility Name

Novo Nordisk Investigational Site

City

Pessac

ZIP/Postal Code

33600

Country

France

Facility Name

Novo Nordisk Investigational Site

City

Pierre Benite

ZIP/Postal Code

69310

Country

France

Facility Name

Novo Nordisk Investigational Site

City

Venissieux

ZIP/Postal Code

69200

Country

France

Facility Name

Novo Nordisk Investigational Site

City

Berlin

ZIP/Postal Code

12627

Country

Germany

Facility Name

Novo Nordisk Investigational Site

City

Bochum

ZIP/Postal Code

44787

Country

Germany

Facility Name

Novo Nordisk Investigational Site

City

Essen

ZIP/Postal Code

45136

Country

Germany

Facility Name

Novo Nordisk Investigational Site

City

Essen

ZIP/Postal Code

45219

Country

Germany

Facility Name

Novo Nordisk Investigational Site

City

Falkensee

ZIP/Postal Code

14612

Country

Germany

Facility Name

Novo Nordisk Investigational Site

City

Frankfurt

ZIP/Postal Code

60313

Country

Germany

Facility Name

Novo Nordisk Investigational Site

City

Giessen

ZIP/Postal Code

35392

Country

Germany

Facility Name

Novo Nordisk Investigational Site

City

Hamburg

ZIP/Postal Code

22607

Country

Germany

Facility Name

Novo Nordisk Investigational Site

City

Hohenmölsen

ZIP/Postal Code

06679

Country

Germany

Facility Name

Novo Nordisk Investigational Site

City

Leipzig

ZIP/Postal Code

04103

Country

Germany

Facility Name

Novo Nordisk Investigational Site

City

Saint Ingbert-Oberwürzbach

ZIP/Postal Code

66386

Country

Germany

Facility Name

Novo Nordisk Investigational Site

City

Stuttgart

ZIP/Postal Code

70378

Country

Germany

Facility Name

Novo Nordisk Investigational Site

City

Wangen

ZIP/Postal Code

88239

Country

Germany

Facility Name

Novo Nordisk Investigational Site

City

Guntur

State/Province

Andhra Pradesh

ZIP/Postal Code

522001

Country

India

Facility Name

Novo Nordisk Investigational Site

City

Secunderabad,

State/Province

Andhra Pradesh

ZIP/Postal Code

500003

Country

India

Facility Name

Novo Nordisk Investigational Site

City

Surat

State/Province

Gujarat

ZIP/Postal Code

395002

Country

India

Facility Name

Novo Nordisk Investigational Site

City

Rohtak

State/Province

Haryana

ZIP/Postal Code

124001

Country

India

Facility Name

Novo Nordisk Investigational Site

City

Thiruvananthapuram

State/Province

Kerala

ZIP/Postal Code

695031

Country

India

Facility Name

Novo Nordisk Investigational Site

City

Nagpur

State/Province

Maharashtra

ZIP/Postal Code

440003

Country

India

Facility Name

Novo Nordisk Investigational Site

City

Pune

State/Province

Maharashtra

ZIP/Postal Code

411004

Country

India

Facility Name

Novo Nordisk Investigational Site

City

Pune

State/Province

Maharashtra

ZIP/Postal Code

411021

Country

India

Facility Name

Novo Nordisk Investigational Site

City

New Dehli

State/Province

New Delhi

ZIP/Postal Code

110029

Country

India

Facility Name

Novo Nordisk Investigational Site

City

Chennai

State/Province

Tamil Nadu

ZIP/Postal Code

600116

Country

India

Facility Name

Novo Nordisk Investigational Site

City

Kolkata

State/Province

West Bengal

ZIP/Postal Code

700054

Country

India

Facility Name

Novo Nordisk Investigational Site

City

Hyderabad

ZIP/Postal Code

500 012

Country

India

Facility Name

Novo Nordisk Investigational Site

City

Ludhiana

ZIP/Postal Code

141001

Country

India

Facility Name

Novo Nordisk Investigational Site

City

Chiba-shi, Chiba

ZIP/Postal Code

260-8677

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Suita-shi, Osaka

ZIP/Postal Code

565-0853

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Tokyo

ZIP/Postal Code

103-0027

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Tokyo

ZIP/Postal Code

103-0028

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Tokyo

ZIP/Postal Code

160-0008

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Guadalajara

State/Province

Jalisco

ZIP/Postal Code

44670

Country

Mexico

Facility Name

Novo Nordisk Investigational Site

City

Hermosillo

State/Province

Sonora

ZIP/Postal Code

83280

Country

Mexico

Facility Name

Novo Nordisk Investigational Site

City

Merida

State/Province

Yucatan

ZIP/Postal Code

97070

Country

Mexico

Facility Name

Novo Nordisk Investigational Site

City

Gdynia

ZIP/Postal Code

81-338

Country

Poland

Facility Name

Novo Nordisk Investigational Site

City

Lodz

ZIP/Postal Code

90-242

Country

Poland

Facility Name

Novo Nordisk Investigational Site

City

Poznan

ZIP/Postal Code

60-589

Country

Poland

Facility Name

Novo Nordisk Investigational Site

City

Szczecin

ZIP/Postal Code

70-376

Country

Poland

Facility Name

Novo Nordisk Investigational Site

City

San Juan

ZIP/Postal Code

00921

Country

Puerto Rico

Facility Name

Novo Nordisk Investigational Site

City

Moscow

ZIP/Postal Code

117036

Country

Russian Federation

Facility Name

Novo Nordisk Investigational Site

City

Novosibirsk

ZIP/Postal Code

630099

Country

Russian Federation

Facility Name

Novo Nordisk Investigational Site

City

Novosibirsk

ZIP/Postal Code

630117

Country

Russian Federation

Facility Name

Novo Nordisk Investigational Site

City

Penza

ZIP/Postal Code

440026

Country

Russian Federation

Facility Name

Novo Nordisk Investigational Site

City

Saint-Petersburg

ZIP/Postal Code

194358

Country

Russian Federation

Facility Name

Novo Nordisk Investigational Site

City

Tomsk

ZIP/Postal Code

634041

Country

Russian Federation

Facility Name

Novo Nordisk Investigational Site

City

Voronezh

ZIP/Postal Code

394018

Country

Russian Federation

Facility Name

Novo Nordisk Investigational Site

City

Yaroslavl

ZIP/Postal Code

150003

Country

Russian Federation

Facility Name

Novo Nordisk Investigational Site

City

Taipei

ZIP/Postal Code

100

Country

Taiwan

Facility Name

Novo Nordisk Investigational Site

City

Bristol

ZIP/Postal Code

BS10 5NB

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

Cambridge

ZIP/Postal Code

CB2 0QQ

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

Coventry

ZIP/Postal Code

CV2 2DX

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

Glasgow

ZIP/Postal Code

G31 2ER

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

Liverpool

ZIP/Postal Code

L9 7AL

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

London

ZIP/Postal Code

SE1 9RT

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

London

ZIP/Postal Code

W1T 7HA

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

Norwich

ZIP/Postal Code

NR4 7UQ

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

Rotherham

ZIP/Postal Code

S65 1DA

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

Taunton

ZIP/Postal Code

TA1 5DA

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

IPD Sharing URL

http://novonordisk-trials.com/sharing-results

Citations:

PubMed Identifier

32441473

Citation

Kushner RF, Calanna S, Davies M, Dicker D, Garvey WT, Goldman B, Lingvay I, Thomsen M, Wadden TA, Wharton S, Wilding JPH, Rubino D. Semaglutide 2.4 mg for the Treatment of Obesity: Key Elements of the STEP Trials 1 to 5. Obesity (Silver Spring). 2020 Jun;28(6):1050-1061. doi: 10.1002/oby.22794.

Results Reference

background

PubMed Identifier

33567185

Citation

Wilding JPH, Batterham RL, Calanna S, Davies M, Van Gaal LF, Lingvay I, McGowan BM, Rosenstock J, Tran MTD, Wadden TA, Wharton S, Yokote K, Zeuthen N, Kushner RF; STEP 1 Study Group. Once-Weekly Semaglutide in Adults with Overweight or Obesity. N Engl J Med. 2021 Mar 18;384(11):989-1002. doi: 10.1056/NEJMoa2032183. Epub 2021 Feb 10.

Results Reference

result

PubMed Identifier

36200477

Citation

Kosiborod MN, Bhatta M, Davies M, Deanfield JE, Garvey WT, Khalid U, Kushner R, Rubino DM, Zeuthen N, Verma S. Semaglutide improves cardiometabolic risk factors in adults with overweight or obesity: STEP 1 and 4 exploratory analyses. Diabetes Obes Metab. 2023 Feb;25(2):468-478. doi: 10.1111/dom.14890. Epub 2022 Oct 28.

Results Reference

derived

PubMed Identifier

35724304

Citation

Perreault L, Davies M, Frias JP, Laursen PN, Lingvay I, Machineni S, Varbo A, Wilding JPH, Wallenstein SOR, le Roux CW. Changes in Glucose Metabolism and Glycemic Status With Once-Weekly Subcutaneous Semaglutide 2.4 mg Among Participants With Prediabetes in the STEP Program. Diabetes Care. 2022 Oct 1;45(10):2396-2405. doi: 10.2337/dc21-1785.

Results Reference

derived

PubMed Identifier

35441470

Citation

Wilding JPH, Batterham RL, Davies M, Van Gaal LF, Kandler K, Konakli K, Lingvay I, McGowan BM, Oral TK, Rosenstock J, Wadden TA, Wharton S, Yokote K, Kushner RF; STEP 1 Study Group. Weight regain and cardiometabolic effects after withdrawal of semaglutide: The STEP 1 trial extension. Diabetes Obes Metab. 2022 Aug;24(8):1553-1564. doi: 10.1111/dom.14725. Epub 2022 May 19.

Results Reference

derived

PubMed Identifier

30122305

Citation

O'Neil PM, Birkenfeld AL, McGowan B, Mosenzon O, Pedersen SD, Wharton S, Carson CG, Jepsen CH, Kabisch M, Wilding JPH. Efficacy and safety of semaglutide compared with liraglutide and placebo for weight loss in patients with obesity: a randomised, double-blind, placebo and active controlled, dose-ranging, phase 2 trial. Lancet. 2018 Aug 25;392(10148):637-649. doi: 10.1016/S0140-6736(18)31773-2. Epub 2018 Aug 16.

Results Reference

derived

Learn more about this trial

STEP 1: Research Study Investigating How Well Semaglutide Works in People Suffering From Overweight or Obesity

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STEP 1: Research Study Investigating How Well Semaglutide Works in People Suffering From Overweight or Obesity (STEP 1)

Metabolism and Nutrition Disorder, Overweight or Obesity

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial