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Trial · Interventional

CompletedPhase 3Results postedRegistry data

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

Short name STEP 3

NCTNCT03611582 (opens ClinicalTrials.gov in a new tab)Other idNN9536-4375Other idU1111-1200-8199
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
611 participants (actual)
Sponsor
Novo Nordisk A/S · Industry
Design
Randomized · Quadruple masking
Countries
1 country

United States

Start
1 Aug 2018
Primary completion
18 Mar 2020
Completion
28 Apr 2020
First posted
2 Aug 2018
Last update posted
11 Nov 2021
Conditions
Overweight · Obesity

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2018201920202021
  1. Ph 3

    STEP 3

    NCT03611582

    1 Aug 2018 to 28 Apr 2020

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • SemaglutideDrug
  • Placebo (semaglutide)Drug

Arms2

  • Experimental

    Semaglutide

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

  • Placebo comparator

    Semaglutide placebo

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

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. Change in Body Weight (%)

    Time frame · Baseline (week 0) to week 68

    Registry description

    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).

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

    Time frame · After 68 weeks

    Registry description

    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 outcomes(20)

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

    Time frame · After 68 weeks

    Registry description

    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).

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

    Time frame · After 68 weeks

    Registry description

    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).

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

    Time frame · After 68 weeks

    Registry description

    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).

  4. Change in Waist Circumference

    Time frame · Baseline (week 0) to week 68

    Registry description

    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).

  5. Change in Systolic Blood Pressure

    Time frame · Baseline (week 0) to week 68

    Registry description

    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).

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

    Time frame · Baseline (week 0) to week 68

    Registry description

    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).

  7. Change in Body Weight (Kg)

    Time frame · Baseline (week 0) to week 68

    Registry description

    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).

  8. Change in Body Mass Index

    Time frame · Baseline (week 0) to week 68

    Registry description

    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).

  9. Change in HbA1c (%)

    Time frame · Baseline (week 0) to week 68

    Registry description

    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).

  10. Change in HbA1c (mmol/Mol)

    Time frame · Baseline (week 0) to week 68

    Registry description

    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).

  11. Change in Fasting Plasma Glucose

    Time frame · Baseline (week 0) to week 68

    Registry description

    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).

  12. Change in Fasting Serum Insulin

    Time frame · Baseline (week 0) to week 68

    Registry description

    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).

  13. Change in Diastolic Blood Pressure

    Time frame · Baseline (week 0) to week 68

    Registry description

    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).

  14. Change in Total Cholesterol

    Time frame · Baseline (week 0) to week 68

    Registry description

    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).

  15. Change in High-density Lipoproteins (HDL)

    Time frame · Baseline (week 0) to week 68

    Registry description

    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).

  16. Change in Low-density Lipoproteins (LDL)

    Time frame · Baseline (week 0) to week 68

    Registry description

    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).

  17. Change in Very Low Density Lipoprotein (VLDL)

    Time frame · Baseline (week 0) to week 68

    Registry description

    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).

  18. Change in Free Fatty Acids

    Time frame · Baseline (week 0) to week 68

    Registry description

    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).

  19. Change in Triglycerides

    Time frame · Baseline (week 0) to week 68

    Registry description

    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).

  20. Change in High Sensitivity C-reactive Protein

    Time frame · Baseline (week 0) to week 68

    Registry description

    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).

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· Baseline (week 0) to week 68

Change in Body Weight (%)

GroupValue (Percentage)Spread
Semaglutide 2.4 mg-16.510.1
Placebo-5.87.7
Primary outcomeCount of participants· After 68 weeks

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

GroupValue (Participants)
Semaglutide 2.4 mg323
Placebo90
Secondary and other outcome results(6)
Secondary outcomeCount of participants· After 68 weeks

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

GroupValue (Participants)
Semaglutide 2.4 mg281
Placebo51
Secondary outcomeCount of participants· After 68 weeks

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

GroupValue (Participants)
Semaglutide 2.4 mg208
Placebo25
Secondary outcomeCount of participants· After 68 weeks

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

GroupValue (Participants)
Semaglutide 2.4 mg133
Placebo7
Secondary outcomeMean· Baseline (week 0) to week 68

Change in Waist Circumference

GroupValue (Centimeter (cm))Spread
Semaglutide 2.4 mg-15.210.2
Placebo-6.18.6
Secondary outcomeMean· Baseline (week 0) to week 68

Change in Systolic Blood Pressure

GroupValue (Millimeters of mercury (mmHg))Spread
Semaglutide 2.4 mg-614
Placebo-215
Secondary outcomeMean· Baseline (week 0) to week 68

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

GroupValue (Score on a scale)Spread
Semaglutide 2.4 mg2.55.7
Placebo1.75.7

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Semaglutide 2.4 mgParticipants were to receive once-weekly subcutaneous (s.c) injection of semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL or 3.2 mg/mL in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to Intensive Behavioural Therapy (IBT), which involves physical activity and dietary intervention with the first 8 weeks of a low-calorie diet (LCD) followed by a strict hypo-caloric diet till the end of treatment.0 / 40737 / 407379 / 407
PlaceboParticipants were to receive once-weekly s.c injection of matching semaglutide placebo using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide placebo 1.0 mg/mL or 3.0 mg/mL or 3.2 mg/mL in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, and 1.7 mg) every fourth week until a maintenance dose of 2.4 mg of semaglutide placebo was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to IBT, which involves physical activity and dietary intervention with the first 8 weeks of LCD followed by a strict hypo-caloric diet till the end of treatment.0 / 2046 / 204177 / 204

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies7

Studies that cite this trial.

Studies with results

3 studies on this page

Indexing hint: Randomized controlled trial · 2024

5 results

Psychiatric Safety of Semaglutide for Weight Management in People Without Known Major Psychopathology: Post Hoc Analysis of the STEP 1, 2, 3, and 5 Trials.

Wadden et al. 2024JAMA internal medicinecited by 77

PMID 39226070PMC11372653DOI 10.1001/jamainternmed.2024.4346PUB-39226070

Free to read · publisher termsCC BY-NC-ND5 results
Read at sourceSee results (5)

Indexing hint: Randomized controlled trial · 2021

6 results

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.

Wadden et al. 2021JAMAcited by 858

PMID 33625476PMC7905697DOI 10.1001/jama.2021.1831PUB-33625476

Rights unknown6 results
Source linkSee results (6)

Indexing hint: Randomized controlled trial · 2020

Semaglutide 2.4 mg for the Treatment of Obesity: Key Elements of the STEP Trials 1 to 5.

Kushner et al. 2020Obesity (Silver Spring, Md.)cited by 209

PMID 32441473PMC7318657DOI 10.1002/oby.22794PUB-32441473

Free to read · publisher termsCC BY-NC
Read at source

Indexing hint: Randomized controlled trial · 2018

10 results

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.

O'Neil et al. 2018Lancet (London, England)cited by 615

PMID 30122305DOI 10.1016/s0140-6736(18)31773-2PUB-30122305

Full text at the publisher10 results
Publisher pageSee results (10)

More studies

3 studies on this page

Indexing hint: Randomized controlled trial · 2024

Corrected

Effect of semaglutide 2.4 mg on physical functioning and weight- and health-related quality of life in adults with overweight or obesity: Patient-reported outcomes from the STEP 1-4 trials.

Rubino et al. 2024Diabetes, obesity & metabolismcited by 38

PMID 38698650DOI 10.1111/dom.15620PUB-38698650

Full text at the publisher
Publisher pageRead the notice

PubMed tag: none · 2023

Effects of Semaglutide on Albuminuria and Kidney Function in People With Overweight or Obesity With or Without Type 2 Diabetes: Exploratory Analysis From the STEP 1, 2, and 3 Trials.

Heerspink et al. 2023Diabetes carecited by 74

PMID 36801984PMC10090901DOI 10.2337/dc22-1889PUB-36801984

Rights unknown
Source link

PubMed tag: none · 2022

Changes in Glucose Metabolism and Glycemic Status With Once-Weekly Subcutaneous Semaglutide 2.4 mg Among Participants With Prediabetes in the STEP Program.

Perreault et al. 2022Diabetes carecited by 61

PMID 35724304PMC9862484DOI 10.2337/dc21-1785PUB-35724304

Rights unknown
Source link

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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