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Research Study to Look at How Well Semaglutide is at Lowering Weight When Taken Together With an Intensive Lifestyle Program (STEP 3)

Primary Purpose

Overweight, Obesity

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Semaglutide

Placebo (semaglutide)

About this trial

This is an interventional treatment trial for Overweight

Eligibility Criteria

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

Inclusion Criteria:

Male or female, age more than or equal to 18 years at the time of signing informed consent
Body mass index more than or equal to 30 kg/m^2 or more than or equal to 27 kg/m^2 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:

Hemoglobin A1c more than or equal to 48 mmol/mol (6.5%) as measured by the 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

Semaglutide placebo

Arm Description

Participants will receive semaglutide 2.4 mg during 68-week treatment period in addition to intensive behavioural therapy.

Participants will receive semaglutide placebo during 68-week treatment period in addition to intensive behavioural therapy.

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 periods. In-trial observation period: the uninterrupted time interval from the start of randomisation (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).

Participants Who Achieve (Yes/no): Body Weight Reduction More Than or Equal to 5%

Number of participants who achieved greater than or equal to (≥) 5% weight loss after 68 weeks is presented. In the reported data, 'Yes' infers the number of participants who have achieved ≥ 5% weight loss, whereas 'No' infers the number of participants who have not achieved ≥ 5% weight loss. 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

Participants Who Achieve (Yes/no): Body Weight Reduction More Than or Equal to 10%

Number of participants who achieved greater than or equal to (≥) 10% weight loss after 68 weeks 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 randomization (week 0) to last trial-related subject-site contact (week 75).

Participants Who Achieve (Yes/no): Body Weight Reduction More Than or Equal to 15%

Number of participants who achieved greater than or equal to (≥) 15% weight loss after 68 weeks 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 randomization (week 0) to last trial-related subject-site contact (week 75).

Participants Who Achieve (Yes/no): Body Weight Reduction More Than or Equal to 20%

Number of participants who achieved greater than or equal to (≥) 20% weight loss after 68 weeks is presented. In the reported data, 'Yes' infers number of participants who have achieved ≥ 20% weight loss whereas 'No' infers number of participants who have not achieved ≥ 20% 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 randomization (week 0) to last trial-related subject-site contact (week 75).

Change in Waist Circumference

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 randomisation (week 0) to last trial-related subject-site contact (week 75).

Change in Systolic Blood Pressure

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 randomisation (week 0) to last trial-related subject-site contact (week 75).

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

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 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 randomisation (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 randomisation (week 0) to last trial-related subject-site contact (week 75).

Change in Body Mass Index

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 randomisation (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 randomisation (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 randomisation (week 0) to last trial-related subject-site contact (week 75).

Change in Fasting Plasma Glucose

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

Change in Fasting Serum Insulin

Change in fasting serum insulin from week 0 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 randomisation (week 0) to last trial-related subject-site contact (week 75).

Change in Diastolic Blood Pressure

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 randomisation (week 0) to last trial-related subject-site contact (week 75).

Change in Total Cholesterol

Change in fasting total cholesterol from baseline (week 0) to week 68 (measured as mg/dL) 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 randomisation (week 0) to last trial-related subject-site contact (week 75).

Change in High-density Lipoproteins (HDL)

Change in fasting HDL from baseline (week 0) to week 68 (measured as mg/dL) 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 randomisation (week 0) to last trial-related subject-site contact (week 75).

Change in Low-density Lipoproteins (LDL)

Change in fasting LDL from baseline (week 0) to week 68 (measured as mg/dL) 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 randomisation (week 0) to last trial-related subject-site contact (week 75).

Change in Very Low Density Lipoprotein (VLDL)

Change in fasting VLDL from baseline (week 0) to week 68 (measured as mg/dL) 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 randomisation (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 0) to week 68 (measured as mg/dL) 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 randomisation (week 0) to last trial-related subject-site contact (week 75).

Change in Triglycerides

Change in fasting triglycerides from baseline (week 0) to week 68 (measured as mg/dL) 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 randomisation (week 0) to last trial-related subject-site contact (week 75).

Change in High Sensitivity C-reactive Protein

Change in high sensitivity C-reactive protein 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 randomisation (week 0) to last trial-related subject-site contact (week 75).

Change in Plasminogen Activator Inhibitor-1 Activity

Change in plasminogen activator inhibitor-1 activity 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 randomisation (week 0) to last trial-related subject-site contact (week 75).

Participants Who Achieve (Yes/no): Responder Definition Value 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 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 overweight or obese population included in the study and calculated using patient global rating anchor questionnaires to reflect participants' own perspective based on Food and Drug Administration (FDA) recommendations. In the reported data, "Yes" infers 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 uninterrupted time interval from randomization (week 0) to last trial related subject-site contact (week 75).

Change in Body Weight

Change in body weight from baseline (week 0) to week 8 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 randomisation (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. 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

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 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

NCT03611582

First Posted

July 17, 2018

Last Updated

November 10, 2021

Sponsor

Novo Nordisk A/S

1. Study Identification

Unique Protocol Identification Number

NCT03611582

Brief Title

Research Study to Look at How Well Semaglutide is at Lowering Weight When Taken Together With an Intensive Lifestyle Program

Acronym

STEP 3

Official Title

Effect and Safety of Semaglutide 2.4 mg Once-weekly as Adjunct to Intensive Behavioural Therapy in Subjects With Overweight or Obesity

Study Type

Interventional

2. Study Status

Record Verification Date

November 2021

Overall Recruitment Status

Completed

Study Start Date

August 1, 2018 (Actual)

Primary Completion Date

March 18, 2020 (Actual)

Study Completion Date

April 28, 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. Together with the medicine, the participant will also be part of an intensive lifestyle program where the participant will have talks with study staff about healthy food choices, what the participant can do to lose weight and be more physically active. The participant will either get semaglutide or "dummy" medicine - which treatment the participant gets is decided by chance. The participant 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. For the first 2 months the participant will be on a low calorie diet. The diet is made up of bars, shakes and 1 low calorie pre-prepared meal for each day. The study will last for about 1.5 years. The participant will have 32 clinic visits with the study doctor.

6. Conditions and Keywords

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

Overweight, Obesity

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

611 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Semaglutide

Arm Type

Experimental

Arm Description

Participants will receive semaglutide 2.4 mg during 68-week treatment period in addition to intensive behavioural therapy.

Arm Title

Semaglutide placebo

Arm Type

Placebo Comparator

Arm Description

Participants will receive semaglutide placebo during 68-week treatment period in addition to intensive behavioural therapy.

Intervention Type

Drug

Intervention Name(s)

Semaglutide

Intervention Description

Subcutaneous (s.c., under the skin) injections of semaglutide once weekly at escalating doses (0.25 mg/week, 0.5 mg/week, 1.0 mg/week, 1.7 mg/week, 2.4 mg/week). The dose will be escalated to next level every 4 weeks.

Intervention Type

Drug

Intervention Name(s)

Placebo (semaglutide)

Intervention Description

S.c. injections of placebo once weekly at a similar dose escalation manner as semaglutide (placebo matched to semaglutide 0.25 mg/week, 0.5 mg/week, 1.0 mg/week, 1.7 mg/week, 2.4 mg/week). The dose will be escalated to next level every 4 weeks.

Primary Outcome Measure Information:

Title

Change in Body Weight (%)

Description

Time Frame

Baseline (week 0) to week 68

Title

Participants Who Achieve (Yes/no): Body Weight Reduction More Than or Equal to 5%

Description

Time Frame

After 68 weeks

Secondary Outcome Measure Information:

Title

Participants Who Achieve (Yes/no): Body Weight Reduction More Than or Equal to 10%

Description

Time Frame

After 68 weeks

Title

Participants Who Achieve (Yes/no): Body Weight Reduction More Than or Equal to 15%

Description

Time Frame

After 68 weeks

Title

Participants Who Achieve (Yes/no): Body Weight Reduction More Than or Equal to 20%

Description

Time Frame

After 68 weeks

Title

Change in Waist Circumference

Description

Time Frame

Baseline (week 0) to week 68

Title

Change in Systolic Blood Pressure

Description

Time Frame

Baseline (week 0) to week 68

Title

Change in Short Form-36 (SF-36) - Physical Functioning 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

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

Description

Time Frame

Baseline (week 0) to week 68

Title

Change in Fasting Serum Insulin

Description

Time Frame

Baseline (week 0) to week 68

Title

Change in Diastolic Blood Pressure

Description

Time Frame

Baseline (week 0) to week 68

Title

Change in Total Cholesterol

Description

Time Frame

Baseline (week 0) to week 68

Title

Change in High-density Lipoproteins (HDL)

Description

Time Frame

Baseline (week 0) to week 68

Title

Change in Low-density Lipoproteins (LDL)

Description

Time Frame

Baseline (week 0) to week 68

Title

Change in Very Low Density Lipoprotein (VLDL)

Description

Time Frame

Baseline (week 0) to week 68

Title

Change in Free Fatty Acids

Description

Time Frame

Baseline (week 0) to week 68

Title

Change in Triglycerides

Description

Time Frame

Baseline (week 0) to week 68

Title

Change in High Sensitivity C-reactive Protein

Description

Time Frame

Baseline (week 0) to week 68

Title

Change in Plasminogen Activator Inhibitor-1 Activity

Description

Time Frame

Baseline (week 0) to week 68

Title

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

Description

Time Frame

After 68 weeks

Title

Change in Body Weight

Description

Time Frame

Baseline (week 0) to week 8

Title

Number of Treatment-emergent Adverse Events (AEs)

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

Description

Time Frame

Baseline (week 0) to week 68

Title

Change in Lipase

Description

Time Frame

Baseline (week 0) to week 68

Title

Change in Calcitonin

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: Male or female, age more than or equal to 18 years at the time of signing informed consent Body mass index more than or equal to 30 kg/m^2 or more than or equal to 27 kg/m^2 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: Hemoglobin A1c more than or equal to 48 mmol/mol (6.5%) as measured by the 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

Birmingham

State/Province

Alabama

ZIP/Postal Code

35294

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Montgomery

State/Province

Alabama

ZIP/Postal Code

36106

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Peoria

State/Province

Arizona

ZIP/Postal Code

85381

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

Escondido

State/Province

California

ZIP/Postal Code

92025

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

Fullerton

State/Province

California

ZIP/Postal Code

92835

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Huntington Beach

State/Province

California

ZIP/Postal Code

92648

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Los Angeles

State/Province

California

ZIP/Postal Code

90057

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Walnut Creek

State/Province

California

ZIP/Postal Code

94598

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Golden

State/Province

Colorado

ZIP/Postal Code

80401

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Kissimmee

State/Province

Florida

ZIP/Postal Code

34744

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

Roswell

State/Province

Georgia

ZIP/Postal Code

30076

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Honolulu

State/Province

Hawaii

ZIP/Postal Code

96814

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

Evanston

State/Province

Illinois

ZIP/Postal Code

60201-2477

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Skokie

State/Province

Illinois

ZIP/Postal Code

60077

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Albany

State/Province

New York

ZIP/Postal Code

12203

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Endwell

State/Province

New York

ZIP/Postal Code

13760

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Chapel Hill

State/Province

North Carolina

ZIP/Postal Code

27517

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

Hickory

State/Province

North Carolina

ZIP/Postal Code

28601

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Raleigh

State/Province

North Carolina

ZIP/Postal Code

27609

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

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104-3317

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

Mount Pleasant

State/Province

South Carolina

ZIP/Postal Code

29464

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Knoxville

State/Province

Tennessee

ZIP/Postal Code

37912

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

Rockwall

State/Province

Texas

ZIP/Postal Code

75032

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

Saint George

State/Province

Utah

ZIP/Postal Code

84790

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

Newport News

State/Province

Virginia

ZIP/Postal Code

23606

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Winchester

State/Province

Virginia

ZIP/Postal Code

22601-3834

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Olympia

State/Province

Washington

ZIP/Postal Code

98502

Country

United States

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

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

33625476

Citation

Wadden TA, Bailey TS, Billings LK, Davies M, Frias JP, Koroleva A, Lingvay I, O'Neil PM, Rubino DM, Skovgaard D, Wallenstein SOR, Garvey WT; STEP 3 Investigators. Effect of Subcutaneous Semaglutide vs Placebo as an Adjunct to Intensive Behavioral Therapy on Body Weight in Adults With Overweight or Obesity: The STEP 3 Randomized Clinical Trial. JAMA. 2021 Apr 13;325(14):1403-1413. doi: 10.1001/jama.2021.1831.

Results Reference

result

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 to Look at How Well Semaglutide is at Lowering Weight When Taken Together With an Intensive Lifestyle Program

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Research Study to Look at How Well Semaglutide is at Lowering Weight When Taken Together With an Intensive Lifestyle Program (STEP 3)

Overweight, 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