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Trial · Interventional

CompletedPhase 3Results postedRegistry data

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

Short name STEP 5

NCTNCT03693430 (opens ClinicalTrials.gov in a new tab)Other idNN9536-4378Other id2017-003726-32Other idU1111-1202-1740Other id2017
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
304 participants (actual)
Sponsor
Novo Nordisk A/S · Industry
Design
Randomized · Quadruple masking
Countries
5 countries

United States, Canada, Hungary, Italy, Spain

Start
5 Oct 2018
Primary completion
29 Jan 2021
Completion
23 Mar 2021
First posted
3 Oct 2018
Last update posted
6 Jul 2023
Conditions
Overweight · Obesity

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20182019202020212022
  1. Ph 3

    STEP 5

    NCT03693430

    5 Oct 2018 to 23 Mar 2021

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 body weight from the start to the end of the study. Researchers will compare the weight loss in people taking semaglutide (a new medicine) to people taking "dummy" medicine. In addition to taking the medicine, participants will also have talks with study staff about healthy food choices, how the participant can be more physically active and what participants can do to lose weight. Participants will either get semaglutide or "dummy" medicine - which treatment the participant gets is decided by chance. Participants will need to take 1 injection once a week. The study medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm. The study will last for about 2 years. The participants will have 19 clinic visits and 15 phone calls with the study doctor.

Interventions

  • SemaglutideDrug
  • Placebo (Semaglutide)Drug

Arms2

  • Experimental

    Semaglutide

    Participants will receive semaglutide 2.4 mg during 104-week treatment period in addition to a reduced-calorie diet and increased physical activity.

  • Placebo comparator

    Placebo

    Participants will receive placebo (semaglutide) during 104-week treatment period in addition to a reduced-calorie diet and increased physical activity.

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. Percentage Change From Baseline (Week 0) to Week 104 in Body Weight

    Time frame · From Baseline (Week 0) to Week 104

    Registry description

    Percentage change in body weight for both in-trial and on-treatment observation period from baseline (week 0) to week 104 is presented. The outcome measure was evaluated based on the data from both in-trial and on-treatment periods. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site. On-treatment observation period: the interval from first to last trial product administration plus 2 weeks of follow-up and excluding any period of temporary treatment interruption defined as \>2 consecutive missed doses (corresponding to \>2 weeks off-treatment).

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

    Time frame · At Week 104

    Registry description

    Number of participants who achieved greater than or equal to (\>=) 5% weight loss at 104 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 outcome measure was evaluated based on the data from both in-trial and on-treatment periods. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site. On-treatment observation period: the interval from first to last trial product administration plus 2 weeks of follow-up and excluding any period of temporary treatment interruption defined as \>2 consecutive missed doses (corresponding to \>2 weeks off-treatment).

Secondary outcomes(20)

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

    Time frame · At Week 104

    Registry description

    Number of participants who achieved \>=10% weight loss at 104 weeks is presented. In the reported data, 'Yes' infers the number of participants who have achieved \>=10% weight loss, whereas 'No' infers the number of participants who have not achieved \>=10% weight loss. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.

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

    Time frame · At Week 104

    Registry description

    Number of participants who achieved \>=15% weight loss at 104 weeks is presented. In the reported data, 'Yes' infers the number of participants who have achieved \>=15% weight loss, whereas 'No' infers the number of participants who have not achieved \>=15% weight loss. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.

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

    Time frame · At Week 104

    Registry description

    Number of participants who achieved \>=20% weight loss at 104 weeks is presented. In the reported data, 'Yes' infers the number of participants who have achieved \>=20% weight loss, whereas 'No' infers the number of participants who have not achieved \>=20% weight loss. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.

  4. Change From Baseline (Week 0) to Week 104 in Waist Circumference

    Time frame · From Baseline (Week 0) to Week 104

    Registry description

    Change in waist circumference from baseline (week 0) to week 104 is presented. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.

  5. Change From Baseline (Week 0) to Week 104 in Body Weight (kg)

    Time frame · From Baseline (Week 0) to Week 104

    Registry description

    Change in body weight from baseline (week 0) to week 104 in kilogram (kg) is presented. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.

  6. Change From Baseline (Week 0) to Week 104 in Body Mass Index (BMI)

    Time frame · From Baseline (Week 0) to Week 104

    Registry description

    Change in BMI from baseline (week 0) to week 104 is presented. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.

  7. Change From Baseline (Week 0) to Week 104 in Systolic Blood Pressure

    Time frame · From Baseline (Week 0) to Week 104

    Registry description

    Change in systolic blood pressure from baseline (week 0) to week 104 is presented. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.

  8. Change From Baseline (Week 0) to Week 104 in Diastolic Blood Pressure

    Time frame · From Baseline (Week 0) to Week 104

    Registry description

    Change in diastolic blood pressure from baseline (week 0) to week 104 is presented. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.

  9. Change in Total Cholesterol-ratio to Baseline

    Time frame · From Baseline (Week 0) to Week 104

    Registry description

    Change in total cholesterol from baseline (week 0) to week 104 measured in milligrams per deciliter (mg/dL) is presented as ratio to baseline. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.

  10. Change in High Density Lipoprotein (HDL) Cholesterol-ratio to Baseline

    Time frame · From Baseline (Week 0) to Week 104

    Registry description

    Change in HDL cholesterol from baseline (week 0) to week 104 measured in mg/dL is presented as ratio to baseline. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.

  11. Change in Low Density Lipoprotein (LDL) Cholesterol-ratio to Baseline

    Time frame · From Baseline (Week 0) to Week 104

    Registry description

    Change in LDL cholesterol from baseline (week 0) to week 104 measured in mg/dL is presented as ratio to baseline. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.

  12. Change in Very Low Density Lipoprotein (VLDL) Cholesterol-ratio to Baseline

    Time frame · From Baseline (Week 0) to Week 104

    Registry description

    Change in VLDL cholesterol from baseline (week 0) to week 104 measured in mg/dL is presented as ratio to baseline. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.

  13. Change in Free Fatty Acids-ratio to Baseline

    Time frame · From Baseline (Week 0) to Week 104

    Registry description

    Change in free fatty acids from baseline (week 0) to week 104 measured in mg/dL is presented as ratio to baseline. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.

  14. Change in Triglycerides-ratio to Baseline

    Time frame · From Baseline (Week 0) to Week 104

    Registry description

    Change in triglycerides from baseline (week 0) to week 104 measured in mg/dL is presented as ratio to baseline. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.

  15. Change in High Sensitivity C-reactive Protein (hsCRP)-Ratio to Baseline

    Time frame · From Baseline (Week 0) to Week 104

    Registry description

    Change in hsCRP from baseline (week 0) to week 104 measured in mg/dL is presented as ratio to baseline. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.

  16. Change in Glycated Haemoglobin (HbA1c) (Percent [%])

    Time frame · From Baseline (Week 0) to Week 104

    Registry description

    Change in HbA1c from baseline (week 0) to week 104 in % is presented. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.

  17. Change From Baseline (Week 0) to Week 104 in HbA1c (mmol/Mol)

    Time frame · From Baseline (Week 0) to Week 104

    Registry description

    Change in HbA1c from baseline (week 0) to week 104 in millimole per mole (mmol/mol) is presented. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.

  18. Change From Baseline (Week 0) to Week 104 in Fasting Plasma Glucose (FPG) (mmol/L)

    Time frame · From Baseline (Week 0) to Week 104

    Registry description

    Change in FPG from baseline (week 0) to week 104 in millimoles per liter (mmol/L) is presented. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.

  19. Change From Baseline (Week 0) to Week 104 in FPG (mg/dL)

    Time frame · From Baseline (Week 0) to Week 104

    Registry description

    Change in FPG from baseline (week 0) to week 104 in mg/dL is presented. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.

  20. Change in Fasting Serum Insulin-ratio to Baseline (Pmol/L)

    Time frame · From Baseline (Week 0) to Week 104

    Registry description

    Change in fasting serum insulin from baseline (week 0) to week 104 measured in picomole per liter (pmol) is presented as ratio to baseline. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.

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· From Baseline (Week 0) to Week 104

Percentage Change From Baseline (Week 0) to Week 104 in Body Weight

GroupValue (percentage change)Spread
Semaglutide 2.4 mg-15.912.3
Placebo-1.98.9
Primary outcomeCount of participants· At Week 104

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

GroupValue (Participants)
Semaglutide 2.4 mg111
Placebo44
Secondary and other outcome results(6)
Secondary outcomeCount of participants· At Week 104

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

GroupValue (Participants)
Semaglutide 2.4 mg89
Placebo17
Secondary outcomeCount of participants· At Week 104

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

GroupValue (Participants)
Semaglutide 2.4 mg75
Placebo9
Secondary outcomeCount of participants· At Week 104

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

GroupValue (Participants)
Semaglutide 2.4 mg52
Placebo3
Secondary outcomeMean· From Baseline (Week 0) to Week 104

Change From Baseline (Week 0) to Week 104 in Waist Circumference

GroupValue (centimeter (cm))Spread
Semaglutide 2.4 mg-15.212.4
Placebo-4.39.1
Secondary outcomeMean· From Baseline (Week 0) to Week 104

Change From Baseline (Week 0) to Week 104 in Body Weight (kg)

GroupValue (kilogram)Spread
Semaglutide 2.4 mg-16.914.0
Placebo-2.19.5
Secondary outcomeMean· From Baseline (Week 0) to Week 104

Change From Baseline (Week 0) to Week 104 in Body Mass Index (BMI)

GroupValue (kilogram per square meter (kg/m^2))Spread
Semaglutide 2.4 mg-6.25.3
Placebo-0.73.5

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Semaglutide 2.4 mgParticipants received once-weekly s.c injection of semaglutide 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 88 weeks until week 104.1 / 15212 / 152141 / 152
PlaceboParticipants received once-weekly s.c. injection of placebo matched to semaglutide for 104 weeks.0 / 15218 / 152117 / 152

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

Studies5

Studies that cite this trial.

Studies with results

4 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 · 2023

12 results

Two-year effect of semaglutide 2.4 mg on control of eating in adults with overweight/obesity: STEP 5.

Wharton et al. 2023Obesity (Silver Spring, Md.)cited by 92

PMID 36655300DOI 10.1002/oby.23673PUB-36655300

Full text at the publisher12 results
Publisher pageSee results (12)

Indexing hint: Randomized controlled trial · 2023

5 results

Effect of semaglutide 2.4 mg once weekly on 10-year type 2 diabetes risk in adults with overweight or obesity.

Wilkinson et al. 2023Obesity (Silver Spring, Md.)cited by 17

PMID 37605636DOI 10.1002/oby.23842PUB-37605636

Full text at the publisher5 results
Publisher pageSee results (5)

Indexing hint: Randomized controlled trial · 2022

3 results

Two-year effects of semaglutide in adults with overweight or obesity: the STEP 5 trial.

Garvey et al. 2022Nature medicinecited by 672

PMID 36216945PMC9556320DOI 10.1038/s41591-022-02026-4PUB-36216945

CC BY3 results
Download PDFSee results (3)

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

Eligibility

Who could join, as posted.

Sex
All
Age
Not stated
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 (BMI) 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: * HbA1c 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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