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Research Study Investigating How Well Semaglutide Works in People Suffering From Overweight or Obesity (STEP 4)

Primary Purpose

Metabolism and Nutrition Disorder, Obesity

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Semaglutide

Placebo

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:

Male or female, age greater than or equal to 18 years at the time of signing informed consent
Body mass index greater than or equal to 30 kg/sqm or greater than or equal to 27 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

Exclusion Criteria:

Haemoglobin A1c greater than or equal to 48 mmol/mol (6.5%) as measured by central laboratory at screening
A self-reported change in body weight more than 5 kg (11 lbs) within 90 days before screening irrespective of medical records

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Semaglutide

Placebo

Arm Description

Run-in Period: Participants will receive semaglutide at an escalating doses (0.25 mg, 0.5 mg, 1 mg, 1.7 mg, 2.4 mg) for 20 weeks (week 0 to week 20). The dose will be escalated to next level every 4 weeks. Maintenance period: Participants will be randomized to receive semaglutide injection for 48 weeks (from week 20 to week 68). The trial product will be administered as an adjunct to a reduced-calorie diet and increased physical activity during the trial period.

Run-in Period: Participants will receive semaglutide at an escalating doses (0.25 mg, 0.5 mg, 1 mg, 1.7 mg, 2.4 mg) for 20 weeks (week 0 to week 20). The dose will be escalated to next level every 4 weeks. Maintenance period: Participants will be randomized to receive semaglutide placebo injection for 48 weeks (from week 20 to week 68). The trial product will be administered as an adjunct to a reduced-calorie diet and increased physical activity during the trial period.

Outcomes

Primary Outcome Measures

Change From Randomisation to Week 68 in Body Weight (%)

Change in body weight from baseline (week 20) 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 start of run-in (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. Temporary treatment interruption is defined as more than 2 consecutive missed doses (off-treatment period).

Secondary Outcome Measures

Change in Waist Circumference

Change in waist circumference from baseline (week 20) 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 run-in (week 0) to last trial-related subject-site contact (week 75).

Change in Systolic Blood Pressure

Change in systolic blood pressure from week 20 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 run-in (week 0) to last trial-related subject-site contact (week 75).

Change in Diastolic Blood Pressure

Change in diastolic blood pressure from week 20 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 run-in (week 0) to last trial-related subject-site contact (week 75).

Change in Physical Functioning Score (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). The 0-100 scale scores from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. In the metric of norm-based scores, 50 and 10 corresponds to the mean and standard deviation respectively. Change from week 20 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 run-in (week 0) to last trial-related subject-site contact (week 75).

Change in Body Weight [Kilogram (Kg)]

Change in body weight from week 20 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 run-in (week 0) to last trial-related subject-site contact (week 75).

Change in Body Mass Index (BMI)

Change in BMI from week 20 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 run-in (week 0) to last trial-related subject-site contact (week 75).

Change in Haemoglobin A1c (HbA1c) [%]

Change in HbA1c from week 20 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 run-in (week 0) to last trial-related subject-site contact (week 75).

Change in HbA1c [Millimoles Per Mole (mmol/Mol)]

Change in Fasting Plasma Glucose [Milligrams Per Deciliter (mg/dL)]

Change in fasting plasma glucose from week 20 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 run-in (week 0) to last trial-related subject-site contact (week 75).

Change in Fasting Plasma Glucose [Millimoles Per Litre (mmol/L)]

Change in Fasting Serum Insulin

Change in fasting serum insulin from baseline (week 20) to week 68 [measured as milli-international units per milliliter (mIU/mL)] 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 run-in (week 0) to last trial-related subject-site contact (week 75).

Change in Total Cholesterol

Change in fasting total cholesterol from baseline (week 20) to week 68 (measured as mmol/L) 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 run-in (week 0) to last trial-related subject-site contact (week 75).

Change in High-density Lipoproteins (HDL)

Change in fasting HDL from baseline (week 20) to week 68 (measured as mmol/L) 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 run-in (week 0) to last trial-related subject-site contact (week 75).

Change in Low-density Lipoproteins (LDL)

Change in fasting LDL from baseline (week 20) to week 68 (measured as mmol/L) 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 run-in (week 0) to last trial-related subject-site contact (week 75).

Change in Very Low-density Lipoproteins (VLDL)

Change in fasting VLDL from baseline (week 20) to week 68 (measured as mmol/L) 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 run-in (week 0) to last trial-related subject-site contact (week 75).

Change in Free Fatty Acids

Change in fasting free fatty acids from baseline (week 20) to week 68 (measured as mmol/L) 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 run-in (week 0) to last trial-related subject-site contact (week 75).

Change in Triglycerides

Change in fasting triglycerides from baseline (week 20) to week 68 (measured as mmol/L) 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 run-in (week 0) to last trial-related subject-site contact (week 75).

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

The number of participants achieving at least a 4.3-point increase in SF-36 physical functioning score from baseline (week 20) to week 68 is presented. In the reported data, 'Yes' infers number of participants who have achieved 4.3 points of increase of the score and 'No' infers number of participants who have not achieved 4.3 points of increase of the score. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of run-in (week 0) to last trial-related subject-site contact (week 75).

Subjects Who Gain Weight (Yes/no)

The number of participants with weight gain from the start of the randomised period (week 20) to week 68 is presented. In the reported data, 'Yes' infers number of participants who have gained weight and 'No' infers number of participants who have not gained weight. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of run-in (week 0) to last trial-related subject-site contact (week 75).

Change in Body Weight

The body weight change (%) from 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 run-in (week 0) to last trial-related subject-site contact (week 75).

Subjects Who Achieve (Yes/no): Body Weight Reduction < 0%

The number of participants who achieved less than (<) 0% weight loss from week 0 to week 68 is presented. In the reported data, 'Yes' infers number of participants who have achieved <0% weight loss whereas 'No' infers number of participants who have not achieved <0% weight loss.The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of run-in (week 0) to last trial-related subject-site contact (week 75).

Subjects Who Achieve (Yes/no): Body Weight Reduction ≥ 5%

The number of participants who achieved greater than or equal to (≥) 5% weight loss from week 0 to week 68 is presented. In the reported data, 'Yes' infers number of participants who have achieved ≥ 5% weight loss whereas 'No' infers number of participants who have not achieved ≥ 5% weight loss. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of run-in (week 0) to last trial-related subject-site contact (week 75).

Subjects Who Achieve (Yes/no): Body Weight Reduction ≥ 10%

The number of participants who achieved ≥ 10% weight loss from week 0 to week 68 is presented. In the reported data, 'Yes' infers number of participants who have achieved ≥ 10% weight loss whereas 'No' infers number of participants who have not achieved ≥ 10% weight loss. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of run-in (week 0) to last trial-related subject-site contact (week 75).

Subjects Who Achieve (Yes/no): Body Weight Reduction ≥ 15%

The number of participants who achieved ≥ 15% weight loss from week 0 to week 68 is presented. In the reported data, 'Yes' infers number of participants who have achieved ≥ 15% weight loss whereas 'No' infers number of participants who have not achieved ≥ 15% weight loss. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of run-in (week 0) to last trial-related subject-site contact (week 75).

Number of Treatment-emergent Adverse Events (AEs)

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 that had onset date (or increase in severity) on or after the first day of exposure to treatment (week 0-20 run-in 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 Treatment-emergent AEs

An 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 TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to treatment (week 20-75). 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 during run-in period from week 0 to week 20 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).

Number of Serious Adverse Events (SAEs)

Change in Pulse

Change in pulse rate from week 0 week to week 20 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 Pulse

Change in pulse from week 20 and 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

Change in amylase (measured as units per liter [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 Amylase

Change in amylase (measured as 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

Change in lipase (measured as 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

Change in Calcitonin

Change in calcitonin (measured as nanogram per liter (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).

Change in Calcitonin

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

NCT03548987

First Posted

May 25, 2018

Last Updated

January 7, 2022

Sponsor

Novo Nordisk A/S

1. Study Identification

Unique Protocol Identification Number

NCT03548987

Brief Title

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

Acronym

STEP 4

Official Title

Effect and Safety of Semaglutide 2.4 mg Once-weekly in Subjects With Overweight or Obesity Who Have Reached Target Dose During run-in Period

Study Type

Interventional

2. Study Status

Record Verification Date

January 2022

Overall Recruitment Status

Completed

Study Start Date

June 4, 2018 (Actual)

Primary Completion Date

February 22, 2020 (Actual)

Study Completion Date

March 20, 2020 (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 participant's body weight from the start to the end of the study. This is to compare the effect on body weight in people taking semaglutide (a new medicine) and people taking "dummy" medicine. In addition to taking the medicine, the participant will have talks with study staff about healthy food choices, how to be more physically active and what a participant can do to lose weight. The participant will get semaglutide for the first 20 weeks. Then the participant will get either semaglutide or "dummy" medicine - which treatment the participant gets after the 20 weeks is decided by chance. The 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 will last for about 1.5 years.

6. Conditions and Keywords

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

Metabolism and Nutrition Disorder, 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

902 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Semaglutide

Arm Type

Experimental

Arm Description

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Run-in Period: Participants will receive semaglutide at an escalating doses (0.25 mg, 0.5 mg, 1 mg, 1.7 mg, 2.4 mg) for 20 weeks (week 0 to week 20). The dose will be escalated to next level every 4 weeks. Maintenance period: Participants will be randomized to receive semaglutide placebo injection for 48 weeks (from week 20 to week 68). The trial product will be administered as an adjunct to a reduced-calorie diet and increased physical activity during the trial period.

Intervention Type

Drug

Intervention Name(s)

Semaglutide

Intervention Description

Subcutaneous (under the skin) injection of semaglutide once-weekly.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Subcutaneous (under the skin) injection of semaglutide placebo once-weekly.

Primary Outcome Measure Information:

Title

Change From Randomisation to Week 68 in Body Weight (%)

Description

Time Frame

Randomisation (week 20) to week 68

Secondary Outcome Measure Information:

Title

Change in Waist Circumference

Description

Time Frame

Randomization (week 20) to week 68

Title

Change in Systolic Blood Pressure

Description

Time Frame

Randomization (week 20) to week 68

Title

Change in Diastolic Blood Pressure

Description

Time Frame

Randomization (week 20) to week 68

Title

Change in Physical Functioning Score (Short Form 36 [SF-36])

Description

Time Frame

Randomization (week 20) to week 68

Title

Change in Body Weight [Kilogram (Kg)]

Description

Time Frame

Randomisation (week 20) to week 68

Title

Change in Body Mass Index (BMI)

Description

Time Frame

Randomization (week 20) to week 68

Title

Change in Haemoglobin A1c (HbA1c) [%]

Description

Time Frame

Randomization (week 20) to week 68

Title

Change in HbA1c [Millimoles Per Mole (mmol/Mol)]

Description

Time Frame

Randomization (week 20) to week 68

Title

Change in Fasting Plasma Glucose [Milligrams Per Deciliter (mg/dL)]

Description

Time Frame

Randomization (week 20) to week 68

Title

Change in Fasting Plasma Glucose [Millimoles Per Litre (mmol/L)]

Description

Time Frame

Randomization (week 20) to week 68

Title

Change in Fasting Serum Insulin

Description

Time Frame

Randomization (week 20) to week 68

Title

Change in Total Cholesterol

Description

Time Frame

Randomization (week 20) to week 68

Title

Change in High-density Lipoproteins (HDL)

Description

Time Frame

Randomization (week 20) to week 68

Title

Change in Low-density Lipoproteins (LDL)

Description

Time Frame

Randomization (week 20) to week 68

Title

Change in Very Low-density Lipoproteins (VLDL)

Description

Time Frame

Randomization (week 20) to week 68

Title

Change in Free Fatty Acids

Description

Time Frame

Randomization (week 20) to week 68

Title

Change in Triglycerides

Description

Time Frame

Randomization (week 20) to week 68

Title

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

Description

Time Frame

Randomisation (week 20) to week 68

Title

Subjects Who Gain Weight (Yes/no)

Description

Time Frame

Randomisation (week 20) to week 68

Title

Change in Body Weight

Description

Time Frame

Run-in (week 0) to week 68

Title

Subjects Who Achieve (Yes/no): Body Weight Reduction < 0%

Description

Time Frame

Run-in (week 0) to week 68

Title

Subjects Who Achieve (Yes/no): Body Weight Reduction ≥ 5%

Description

Time Frame

Run-in (week 0) to week 68

Title

Subjects Who Achieve (Yes/no): Body Weight Reduction ≥ 10%

Description

Time Frame

Run-in (week 0) to week 68

Title

Subjects Who Achieve (Yes/no): Body Weight Reduction ≥ 15%

Description

Time Frame

Run-in (week 0) to week 68

Title

Number of Treatment-emergent Adverse Events (AEs)

Description

Time Frame

Run-in (week 0) to randomisation (week 20)

Title

Number of Treatment-emergent AEs

Description

Time Frame

Randomisation (week 20) to week 75

Title

Number of Serious Adverse Events (SAEs)

Description

Time Frame

Run-in (week 0) to randomisation (week 20)

Title

Number of Serious Adverse Events (SAEs)

Description

Time Frame

Randomisation (week 20) to week 75

Title

Change in Pulse

Description

Time Frame

Run-in (week 0) to randomisation (week 20)

Title

Change in Pulse

Description

Time Frame

Randomisation (week 20) to week 68

Title

Change in Amylase

Description

Time Frame

Run-in (week) 0 to randomization (week 20)

Title

Change in Amylase

Description

Time Frame

Randomisation (week 20) to week 68

Title

Change in Lipase

Description

Time Frame

Run-in (week 0) to randomization (week 20)

Title

Change in Lipase

Description

Time Frame

Randomisation (week 20) to week 68

Title

Change in Calcitonin

Description

Time Frame

Run-in (week 0) to randomization (week 20)

Title

Change in Calcitonin

Description

Time Frame

Randomisation (week 20) to week 68

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male or female, age greater than or equal to 18 years at the time of signing informed consent Body mass index greater than or equal to 30 kg/sqm or greater than or equal to 27 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 Exclusion Criteria: Haemoglobin A1c greater than or equal to 48 mmol/mol (6.5%) as measured by central laboratory at screening A self-reported change in body weight more than 5 kg (11 lbs) within 90 days before screening irrespective of medical records

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

Fresno

State/Province

California

ZIP/Postal Code

93720

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

San Diego

State/Province

California

ZIP/Postal Code

92108

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Alpharetta

State/Province

Georgia

ZIP/Postal Code

30022

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

Suwanee

State/Province

Georgia

ZIP/Postal Code

30024

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

Baton Rouge

State/Province

Louisiana

ZIP/Postal Code

70808

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Elkridge

State/Province

Maryland

ZIP/Postal Code

21075-6437

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

Omaha

State/Province

Nebraska

ZIP/Postal Code

68198-3020

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

New York

State/Province

New York

ZIP/Postal Code

10016

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Greensboro

State/Province

North Carolina

ZIP/Postal Code

27408

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Greenville

State/Province

North Carolina

ZIP/Postal Code

27834

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Raleigh

State/Province

North Carolina

ZIP/Postal Code

27612

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

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45242

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Dayton

State/Province

Ohio

ZIP/Postal Code

45406

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Bristol

State/Province

Tennessee

ZIP/Postal Code

37620-7352

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Bristol

State/Province

Tennessee

ZIP/Postal Code

37620

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Chattanooga

State/Province

Tennessee

ZIP/Postal Code

37404

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Austin

State/Province

Texas

ZIP/Postal Code

78731

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

75231

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Arlington

State/Province

Virginia

ZIP/Postal Code

22206

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23226

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Wenatchee

State/Province

Washington

ZIP/Postal Code

98801-2028

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Frederiksberg C

ZIP/Postal Code

1958

Country

Denmark

Facility Name

Novo Nordisk Investigational Site

City

Køge

ZIP/Postal Code

4600

Country

Denmark

Facility Name

Novo Nordisk Investigational Site

City

Haifa

ZIP/Postal Code

35152

Country

Israel

Facility Name

Novo Nordisk Investigational Site

City

Jerusalem

ZIP/Postal Code

91120

Country

Israel

Facility Name

Novo Nordisk Investigational Site

City

Kfar Saba

ZIP/Postal Code

44281

Country

Israel

Facility Name

Novo Nordisk Investigational Site

City

Petah-Tikva

ZIP/Postal Code

49372

Country

Israel

Facility Name

Novo Nordisk Investigational Site

City

Tel Hashomer

ZIP/Postal Code

52621

Country

Israel

Facility Name

Novo Nordisk Investigational Site

City

Tel-Aviv

ZIP/Postal Code

64239

Country

Israel

Facility Name

Novo Nordisk Investigational Site

City

Amsterdam

ZIP/Postal Code

1066 EC

Country

Netherlands

Facility Name

Novo Nordisk Investigational Site

City

Amsterdam

ZIP/Postal Code

1105 AZ

Country

Netherlands

Facility Name

Novo Nordisk Investigational Site

City

Arnhem

ZIP/Postal Code

6815 AD

Country

Netherlands

Facility Name

Novo Nordisk Investigational Site

City

Braga

ZIP/Postal Code

4710-243

Country

Portugal

Facility Name

Novo Nordisk Investigational Site

City

Coimbra

ZIP/Postal Code

3000-561

Country

Portugal

Facility Name

Novo Nordisk Investigational Site

City

Matosinhos

ZIP/Postal Code

4464-513

Country

Portugal

Facility Name

Novo Nordisk Investigational Site

City

Porto

ZIP/Postal Code

4099-001

Country

Portugal

Facility Name

Novo Nordisk Investigational Site

City

Porto

ZIP/Postal Code

4200-319

Country

Portugal

Facility Name

Novo Nordisk Investigational Site

City

Vila Nova de Gaia

ZIP/Postal Code

4400-346

Country

Portugal

Facility Name

Novo Nordisk Investigational Site

City

Johannesburg

State/Province

Gauteng

ZIP/Postal Code

2001

Country

South Africa

Facility Name

Novo Nordisk Investigational Site

City

Johannesburg

State/Province

Gauteng

ZIP/Postal Code

2013

Country

South Africa

Facility Name

Novo Nordisk Investigational Site

City

Pretoria

State/Province

Gauteng

ZIP/Postal Code

0181

Country

South Africa

Facility Name

Novo Nordisk Investigational Site

City

Pretoria

State/Province

Gauteng

ZIP/Postal Code

0184

Country

South Africa

Facility Name

Novo Nordisk Investigational Site

City

Durban

State/Province

KwaZulu-Natal

ZIP/Postal Code

4001

Country

South Africa

Facility Name

Novo Nordisk Investigational Site

City

Brits

State/Province

North West

ZIP/Postal Code

0250

Country

South Africa

Facility Name

Novo Nordisk Investigational Site

City

Almeria

ZIP/Postal Code

04009

Country

Spain

Facility Name

Novo Nordisk Investigational Site

City

Madrid

ZIP/Postal Code

28009

Country

Spain

Facility Name

Novo Nordisk Investigational Site

City

Madrid

ZIP/Postal Code

28040

Country

Spain

Facility Name

Novo Nordisk Investigational Site

City

Sabadell

ZIP/Postal Code

08208

Country

Spain

Facility Name

Novo Nordisk Investigational Site

City

Sevilla

ZIP/Postal Code

41003

Country

Spain

Facility Name

Novo Nordisk Investigational Site

City

Sevilla

ZIP/Postal Code

41009

Country

Spain

Facility Name

Novo Nordisk Investigational Site

City

Sevilla

ZIP/Postal Code

41013

Country

Spain

Facility Name

Novo Nordisk Investigational Site

City

Malmö

ZIP/Postal Code

205 02

Country

Sweden

Facility Name

Novo Nordisk Investigational Site

City

Stockholm

ZIP/Postal Code

141 86

Country

Sweden

Facility Name

Novo Nordisk Investigational Site

City

Uppsala

ZIP/Postal Code

751 85

Country

Sweden

Facility Name

Novo Nordisk Investigational Site

City

Genève 14

ZIP/Postal Code

1211

Country

Switzerland

Facility Name

Novo Nordisk Investigational Site

City

Olten

ZIP/Postal Code

4600

Country

Switzerland

Facility Name

Novo Nordisk Investigational Site

City

St. Gallen

ZIP/Postal Code

9007

Country

Switzerland

Facility Name

Novo Nordisk Investigational Site

City

St. Gallen

ZIP/Postal Code

9016

Country

Switzerland

Facility Name

Novo Nordisk Investigational Site

City

Zollikerberg

ZIP/Postal Code

8125

Country

Switzerland

Facility Name

Novo Nordisk Investigational Site

City

Zürich

ZIP/Postal Code

8091

Country

Switzerland

Facility Name

Novo Nordisk Investigational Site

City

Kharkiv

ZIP/Postal Code

61039

Country

Ukraine

Facility Name

Novo Nordisk Investigational Site

City

Kyiv

ZIP/Postal Code

03039

Country

Ukraine

Facility Name

Novo Nordisk Investigational Site

City

Kyiv

ZIP/Postal Code

04050

Country

Ukraine

Facility Name

Novo Nordisk Investigational Site

City

Kyiv

ZIP/Postal Code

04114

Country

Ukraine

Facility Name

Novo Nordisk Investigational Site

City

Odesa

ZIP/Postal Code

65059

Country

Ukraine

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

33755728

Citation

Rubino D, Abrahamsson N, Davies M, Hesse D, Greenway FL, Jensen C, Lingvay I, Mosenzon O, Rosenstock J, Rubio MA, Rudofsky G, Tadayon S, Wadden TA, Dicker D; STEP 4 Investigators. Effect of Continued Weekly Subcutaneous Semaglutide vs Placebo on Weight Loss Maintenance in Adults With Overweight or Obesity: The STEP 4 Randomized Clinical Trial. JAMA. 2021 Apr 13;325(14):1414-1425. doi: 10.1001/jama.2021.3224.

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

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

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

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Research Study Investigating How Well Semaglutide Works in People Suffering From Overweight or Obesity (STEP 4)

Metabolism and Nutrition Disorder, 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