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Trial · Interventional

CompletedPhase 3Results postedRegistry data

STEP 6: Research Study Investigating How Well Semaglutide Works in People Living With Overweight or Obesity

Short name STEP 6

NCTNCT03811574 (opens ClinicalTrials.gov in a new tab)Other idNN9536-4382Other idU1111-1201-1629
Open at ClinicalTrials.govAsk about this trial

Overview

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

Japan, South Korea

Start
21 Jan 2019
Primary completion
20 Nov 2020
Completion
20 Nov 2020
First posted
22 Jan 2019
Last update posted
22 Mar 2022
Conditions
Overweight · Obesity

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201920202021
  1. Ph 3

    STEP 6

    NCT03811574

    21 Jan 2019 to 20 Nov 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 participants' 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, participants will have talks with study staff about healthy food choices, how to be more physically active and what participants can do to lose weight. Participants will either get semaglutide or "dummy" medicine - which treatment participants get is decided by chance. Participants are three times as likely to get semaglutide as "dummy" medicine. Participants will need to take 1 injection once a week. The study medicine is injected with a thin needle in a skinfold in the stomach, thigh or upper arm. The study will last for about one and a half years. Participants will have 14 clinic visits and 11 phone calls with the study doctor.

Interventions

  • SemaglutideDrug
  • Placebo (semaglutide)Drug

Arms4

  • Experimental

    Semaglutide 2.4 mg

    Participants will receive semaglutide injections once-weekly for 68 weeks. Participants will be initiated at a once-weekly dose of 0.25 mg and follow a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), until the target dose (2.4 mg) is reached after 16 weeks. Participants will continue semaglutide 2.4 mg until week 68.

  • Placebo comparator

    Placebo (semaglutide 2.4 mg)

    Participants will receive placebo (semaglutide) injections once-weekly for 68 weeks. Participants will be initiated at a once-weekly dose of 0.25 mg and follow a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), until the target dose (2.4 mg) is reached after 16 weeks. Participants will continue placebo (semaglutide 2.4 mg) until week 68.

  • Experimental

    Semaglutide 1.7 mg

    Participants will receive semaglutide injections once-weekly for 68 weeks. Participants will be initiated at a once-weekly dose of 0.25 mg and follow a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0 and 1.7 mg/week), until the target dose (1.7 mg) is reached after 12 weeks. Participants will continue semaglutide 1.7 mg until week 68.

  • Placebo comparator

    Placebo (semaglutide 1.7 mg)

    Participants will receive placebo (semaglutide) injections once-weekly for 68 weeks. Participants will be initiated at a once-weekly dose of 0.25 mg and follow a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0 and 1.7 mg/week), until the target dose (1.7 mg) is reached after 12 weeks. Participants will continue placebo (semaglutide 1.7) until week 68.

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. Change in Body Weight (%)

    Time frame · Baseline (week 0), week 68

    Registry description

    Change from baseline (week 0) in body weight for 'in-trial' observation period at week 68 is presented. In-trial observation period: the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact (week 75).

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

    Time frame · At week 68

    Registry description

    Number of participants who achieved greater than or equal to (≥) 5% weight loss at week 68 for in-trial observation period 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. In-trial observation period: the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact (week 75).

Secondary outcomes(20)

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

    Time frame · At week 68

    Registry description

    Number of participants who achieved greater than or equal to (≥) 10% weight loss at week 68 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 endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from the start of randomisation to last trial-related subject-site contact.

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

    Time frame · At week 68

    Registry description

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

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

    Time frame · At week 68

    Registry description

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

  4. Change in Waist Circumference Measured Midway Between the Lower Rib Margin and the Iliac Crest

    Time frame · Baseline (week 0) to week 68

    Registry description

    Change in waist circumference measured midway between the lower rib margin and the iliac crest 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 the start of randomisation to last trial-related subject-site contact.

  5. Change in Waist Circumference Measured According to the JASSO (Japan Society for the Study of Obesity) Guideline

    Time frame · Baseline (week 0) to week 68

    Registry description

    Change in Waist circumference measured according to the JASSO guideline 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 the start of randomisation to last trial-related subject-site contact.

  6. 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 the start of randomisation to last trial-related subject-site contact.

  7. Change in Body Mass Index (BMI)

    Time frame · Baseline (week 0) to week 68

    Registry description

    Change in BMI 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 the start of randomisation to last trial-related subject-site contact.

  8. Change in Visceral Fat Area (VFA) (%)

    Time frame · Baseline (week 0) to week 68

    Registry description

    Change in VFA 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 the start of randomisation to last trial-related subject-site contact.

  9. Change in Visceral Fat Area (VFA) Centimeter Square (cm^2)

    Time frame · Baseline (week 0) to week 68

    Registry description

    Change in VFA 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 the start of randomisation to last trial-related subject-site contact.

  10. 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 the start of randomisation to last trial-related subject-site contact.

  11. Change in HbA1c (mmol/Mol)

    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 the start of randomisation to last trial-related subject-site contact.

  12. Change in Fasting Plasma Glucose

    Time frame · Baseline (week 0) to week 68

    Registry description

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

  13. Change in Fasting Serum Insulin-ratio to Baseline

    Time frame · Baseline (week 0) to week 68

    Registry description

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

  14. 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 the start of randomisation to last trial-related subject-site contact.

  15. 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 the start of randomisation to last trial-related subject-site contact.

  16. Change in Total Cholesterol-ratio to Baseline

    Time frame · Baseline (week 0) to week 68

    Registry description

    Change in total cholesterol measured as milligrams per deciliter (mg/dL) from baseline (week 0) to week 68 is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from the start of randomisation to last trial-related subject-site contact.

  17. Change in High-density Lipoproteins (HDL)-Ratio to Baseline

    Time frame · Baseline (week 0) to week 68

    Registry description

    Change in HDL measured as milligrams per deciliter (mg/dL) from baseline (week 0) to week 68 is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from the start of randomisation to last trial-related subject-site contact.

  18. Change in Low-density Lipoproteins (LDL)-Ratio to Baseline

    Time frame · Baseline (week 0) to week 68

    Registry description

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

  19. Change in Very Low-density Lipoproteins (VLDL)-Ratio to Baseline

    Time frame · Baseline (week 0) to week 68

    Registry description

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

  20. Change in Free Fatty Acids-ratio to Baseline

    Time frame · Baseline (week 0) to week 68

    Registry description

    Change in free fatty acids measured as milligrams per deciliter (mg/dL) from baseline (week 0) to week 68 is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from the start of randomisation to last trial-related subject-site contact.

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), week 68

Change in Body Weight (%)

GroupValue (Percentage change)Spread
Semaglutide 1.7 mg-9.97.8
Semaglutide 2.4 mg-13.48.6
Placebo-1.95.9
Primary outcomeCount of participants· At week 68

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

GroupValue (Participants)
Semaglutide 1.7 mg71
Semaglutide 2.4 mg160
Placebo21
Secondary and other outcome results(6)
Secondary outcomeCount of participants· At week 68

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

GroupValue (Participants)
Semaglutide 1.7 mg41
Semaglutide 2.4 mg117
Placebo5
Secondary outcomeCount of participants· At week 68

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

GroupValue (Participants)
Semaglutide 1.7 mg24
Semaglutide 2.4 mg79
Placebo3
Secondary outcomeCount of participants· At week 68

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

GroupValue (Participants)
Semaglutide 1.7 mg11
Semaglutide 2.4 mg38
Placebo2
Secondary outcomeMean· Baseline (week 0) to week 68

Change in Waist Circumference Measured Midway Between the Lower Rib Margin and the Iliac Crest

GroupValue (Centimeter (cm))Spread
Semaglutide 1.7 mg-7.86.9
Semaglutide 2.4 mg-11.27.5
Placebo-1.85.9
Secondary outcomeMean· Baseline (week 0) to week 68

Change in Waist Circumference Measured According to the JASSO (Japan Society for the Study of Obesity) Guideline

GroupValue (Centimeter (cm))Spread
Semaglutide 1.7 mg-7.65.7
Semaglutide 2.4 mg-10.26.8
Placebo-1.95.3
Secondary outcomeMean· Baseline (week 0) to week 68

Change in Body Weight (Kg)

GroupValue (Kilogram (kg))Spread
Semaglutide 1.7 mg-8.36.1
Semaglutide 2.4 mg-11.37.3
Placebo-1.75.6

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Semaglutide 1.7 mgParticipants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0 and 1.7 mg/week), aiming at reaching the maintenance dose of 1.7 mg once-weekly after 12 weeks. Treatment was continued on the maintenance dose of 1.7 mg once-weekly for an additional 56 weeks until week 68. The treatment was an adjunct to a reduced calorie diet and increased physical activity.0 / 1007 / 10073 / 100
Semaglutide 2.4 mgParticipants were to receive once-weekly s.c. injection of 0.25 mg semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg once-weekly after 16 weeks. 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 a reduced calorie diet and increased physical activity.0 / 19910 / 199142 / 199
PlaceboParticipants were to receive once-weekly s.c. injection of placebo matched to semaglutide for 68 weeks.0 / 1017 / 10149 / 101

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

Studies3

Studies that cite this trial.

Studies with results

3 studies on this page

Indexing hint: Randomized controlled trial · 2025

9 results

Effect of once-weekly subcutaneous semaglutide on abdominal visceral fat area in Japanese adults with overweight and obesity: A post hoc analysis of the STEP 6 trial.

Kadowaki et al. 2025Obesity research & clinical practicecited by 6

PMID 40189961DOI 10.1016/j.orcp.2025.03.003PUB-40189961

Full text at the publisher9 results
Publisher pageSee results (9)

Indexing hint: Randomized controlled trial · 2022

12 results

Semaglutide once a week in adults with overweight or obesity, with or without type 2 diabetes in an east Asian population (STEP 6): a randomised, double-blind, double-dummy, placebo-controlled, phase 3a trial.

Kadowaki et al. 2022The lancet. Diabetes & endocrinologycited by 249

PMID 35131037DOI 10.1016/s2213-8587(22)00008-0PUB-35131037

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

Indexing hint: Randomized controlled trial · 2021

6 results

Semaglutide 2·4 mg once a week in adults with overweight or obesity, and type 2 diabetes (STEP 2): a randomised, double-blind, double-dummy, placebo-controlled, phase 3 trial.

Davies et al. 2021Lancet (London, England)cited by 1,104

PMID 33667417DOI 10.1016/s0140-6736(21)00213-0PUB-33667417

Full text at the publisher6 results
Publisher pageSee results (6)

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 * BMI more than or equal to 27.0 kg/m\^2 with more than or equal to 2 weight related comorbidities (treated or untreated) or BMI more than or equal to 35.0 kg/m\^2 with more than or equal to 1 weight related comorbidity (treated or untreated) according to the JASSO guideline. At least one comorbidity should be hypertension or dyslipidaemia (Japan only: or T2D) * History of at least one self-reported unsuccessful dietary effort to lose body weight * For subjects with T2D at screening (Japan only): a) Diagnosed with T2D more than or equal to 180 days prior to the day of screening. b) HbA1c 7.0-10.0% (53-86 mmol/mol) (both inclusive) Exclusion Criteria: * A self-reported change in body weight more than 5 kg (11 lbs) within 90 days before screening irrespective of medical records * For subjects without T2D at screening: HbA1c more than or equal to 48 mmol/mol (6.5%) as measured by the central laboratory at screening * For subjects with T2D at screening (Japan only): a) Renal impairment measured as estimated glomerular filtration rate (eGFR) value of less than 30 mL/min/1.73 m\^2 (less than 60 mL/min/1.73 m\^2 in subjects treated with sodium-glucose co-transporter 2 inhibitor (SGLT2i)) according to chronic kidney disease epidemiology (CKD-EPI) creatinine equation as defined by kidney disease improving global outcome (KDIGO) 2012 by the central laboratory at screening. b) Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a pharmacologically pupil-dilated fundus examination performed by an ophthalmologist or another suitably qualified health care provider within the past 90 days prior to screening or in the period between screening and randomisation

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