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Trial · Interventional

CompletedPhase 3Results postedRegistry data

Research Study of How Well Semaglutide Works in People Living With Overweight or Obesity.

Short name STEP7

NCTNCT04251156 (opens ClinicalTrials.gov in a new tab)Other idNN9536-4379Other idU1111-1212-2189
Open at ClinicalTrials.govAsk about this trial

Overview

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

Brazil, China, Hong Kong, South Korea

Start
8 Dec 2020
Primary completion
23 Aug 2022
Completion
23 Aug 2022
First posted
31 Jan 2020
Last update posted
29 Jan 2026
Conditions
Overweight · Obesity · Diabetes Mellitus, Type 2

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2020202120222023
  1. Ph 3

    STEP7

    NCT04251156

    8 Dec 2020 to 23 Aug 2022

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. The purpose of the study 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 else they can do to lose weight. Participants will either get semaglutide or "dummy medicine" - which treatment 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 skinfold in the stomach, thigh or upper arm.• The study will last for about 1 year. Participants will have 11 clinic visits and 8 phone calls with the study doctor. Participants will have 3 clinic visits where they cannot eat and drink (water is allowed) for up to 8 hours before the visit and 1 clinic visit where they cannot eat and drink for up to 2 hours before the visit. (4 visits and 1 visit, respectively, if they have type 2 diabetes (T2D)). Participants will have 4 clinic visits where they will have blood samples taken. (5 visits if they have T2D). For China: Participants will have 9 clinic visits where they will have blood samples taken. Women cannot take part if pregnant, breast-feeding or planning to become pregnant during the study period.

Interventions

  • SemaglutideDrug
  • Placebo (semaglutide)Drug

Arms2

  • Experimental

    Semaglutide

    Once-weekly injections of gradually increased doses of semaglutide

  • Placebo comparator

    Placebo (semaglutide)

    Once-weekly injections of gradually increased doses of semaglutide placebo

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. Change From Baseline in Body Weight (Percentage [%])

    Time frame · Baseline (week 0), week 44

    Registry description

    Change from baseline at week 0 to week 44 in body weight (%) 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 the start of randomization (week 0) to last trial-related participant-site contact (week 51).

  2. Number of Participants Who Achieved Body Weight Reduction Greater Than or Equal (>=) to 5% (Yes/No)

    Time frame · At week 44

    Registry description

    Number of participants who achieved \>=5% weight reduction at week 44 for in-trial observation period is presented.In the reported data, 'Yes' infers the number of participants who have achieved greater than or equal to 5% weight reduction, whereas 'No' infers the number of participants who have not achieved greater than or equal to 5% weight reduction. In-trial observation period: the uninterrupted time interval from the start of randomization (week 0) to last trial-related participant-site contact (week 51).

Secondary outcomes(20)

  1. Number of Participants Who Achieved Body Weight Reduction Greater Than or Equal (>=) to 10% (Yes/No)

    Time frame · At week 44

    Registry description

    Number of participants who achieved \>=10% weight reduction at week 44 for in-trial observation period is presented. In the reported data, 'Yes' infers the number of participants who have achieved greater than or equal to 10% weight reduction, whereas 'No' infers the number of participants who have not achieved greater than or equal to 10% weight reduction. In-trial observation period: the uninterrupted time interval from the start of randomization (week 0) to last trial-related participant-site contact (week 51).

  2. Number of Participants Who Achieved Body Weight Reduction Greater Than or Equal (>=) to 15% (Yes/No)

    Time frame · At week 44

    Registry description

    Number of participants who achieved \>=15% weight reduction at week 44 for in-trial observation period is presented. In the reported data, 'Yes' infers the number of participants who have achieved greater than or equal to 15% weight reduction, whereas 'No' infers the number of participants who have not achieved greater than or equal to 15% weight reduction. In-trial observation period: the uninterrupted time interval from the start of randomization (week 0) to last trial-related participant-site contact (week 51).

  3. Change From Baseline in Waist Circumference

    Time frame · Baseline (week 0), week 44

    Registry description

    Change in waist circumference from baseline (week 0) to week 44 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 start of randomization (week 0) to last trial-related participant-site contact (week 51).

  4. Change From Baseline in Body Weight (Kilogram [kg])

    Time frame · Baseline (week 0), week 44

    Registry description

    Change in body weight from baseline (week 0) to week 44 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 the start of randomization (week 0) to last trial-related participant-site contact (week 51).

  5. Change From Baseline in Body Mass Index (BMI)

    Time frame · Baseline (week 0), week 44

    Registry description

    Change in BMI from baseline (week 0) to week 44 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 the start of randomization (week 0) to last trial-related participant-site contact (week 51).

  6. Number of Participants Who Achieved Body Weight Reduction Greater Than or Equal (>=) to 20% (Yes/No)

    Time frame · At week 44

    Registry description

    Number of participants who achieved \>=20% weight reduction at week 44 for in-trial observation period is presented. In the reported data, 'Yes' infers the number of participants who have achieved greater than or equal to 20% weight reduction, whereas 'No' infers the number of participants who have not achieved greater than or equal to 20% weight reduction. In-trial observation period: the uninterrupted time interval from the start of randomization (week 0) to last trial-related participant-site contact (week 51).

  7. Change From Baseline in Systolic Blood Pressure

    Time frame · Baseline (week 0), week 44

    Registry description

    Change in systolic blood pressure from baseline (week 0) to week 44 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 the start of randomization (week 0) to last trial-related participant-site contact (week 51).

  8. Change From Baseline in Short Form-36 (SF-36) - Physical Functioning Score

    Time frame · Baseline (week 0), week 44

    Registry description

    SF-36 is a 36-item participants-reported survey of participants health that measures the partici-pants overall health-related quality of life (HRQoL). SF-36 questionnaire measured 8 domains of functional health and well-being as well as 2 component summary scores (physical component summary and mental component summary). This outcome measure shows results for 'physical functioning domain'. Physical function domain score ranges from 0 to 100, with higher values indicating better functional health and well-being. Change from baseline (week 0) in the domain scores were evaluated at week 44. These outcome measures were evaluated based on data from in-trial observation period which is the uninterrupted time interval from (week 0) to (week 51).

  9. Change From Baseline in Impact of Weight on Quality of Life-Lite for Clinical Trials (IWQOL-Lite for CT) - Physical Function Domain (5-items) Score

    Time frame · Baseline (week 0), week 44

    Registry description

    The Impact of Weight on Quality of Life Clinical Trials Version (IWQOL-Lite-CT) is designed to assess the impact of changes in weight on participants quality of life within the context of clinical trials. IWQOL-Lite-CT is a 20-item questionnaire-based instrument used to assess the impact of body weight changes on participants overall health-related quality of life (HRQoL). All IWQOL-Lite-CT composite and physical function domain scores range from 0 to 100, with higher scores reflecting better levels of functioning. This outcome measure shows results for 'physical function domain'. The outcome measure 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 participant-site contact (week 51).

  10. Change From Baseline in Glycosylated Haemoglobin (HbA1c) (Percentage [%])

    Time frame · Baseline (week 0), week 44

    Registry description

    Change in glycosylated haemoglobin (HbA1c) (%) from baseline (week 0) to week 44 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 the start of randomization (week 0) to last trial-related participant-site contact (week 51).

  11. Change From Baseline in HbA1c (Millimoles Per Mole [mmol/Mol])

    Time frame · Baseline (week 0), week 44

    Registry description

    Change in HbA1c (mmol/mol) from baseline (week 0) to week 44 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 the start of randomization (week 0) to last trial-related participant-site contact (week 51).

  12. Change From Baseline in Fasting Plasma Glucose (FPG) (Milligrams Per Deciliter [mg/dL])

    Time frame · Baseline (week 0), week 44

    Registry description

    Change in fasting plasma glucose (mg/dL) from baseline (week 0) to week 44 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 the start of randomization (week 0) to last trial-related participant-site contact (week 51).

  13. Change From Baseline in FPG (Millimoles Per Liter [mmol/L])

    Time frame · Baseline (week 0), week 44

    Registry description

    Change in FPG (mmol/L) from baseline (week 0) to week 44 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 the start of randomization (week 0) to last trial-related participant-site contact (week 51).

  14. Change From Baseline in Fasting Serum Insulin: Ratio to Baseline

    Time frame · Baseline (week 0), week 44

    Registry description

    Change in fasting serum insulin measured as milli-international units per milliliter (mIU/mL) from baseline (week 0) to week 44 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 the start of randomization (week 0) to last trial-related participant-site contact (week 51).

  15. Change From Baseline in Diastolic Blood Pressure

    Time frame · Baseline (week 0), week 44

    Registry description

    Change in diastolic blood pressure from baseline (week 0) to week 44 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 the start of randomization (week 0) to last trial-related participant-site contact (week 51).

  16. Change From Baseline in Total Cholesterol: Ratio to Baseline

    Time frame · Baseline (week 0), week 44

    Registry description

    Change in total cholesterol measured as milligrams per deciliter (mg/dL) from baseline (week 0) to week 44 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 the start of randomization (week 0) to last trial-related participant-site contact (week 51).

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

    Time frame · Baseline (week 0), week 44

    Registry description

    Change in HDL measured as milligrams per deciliter (mg/dL) from baseline (week 0) to week 44 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 the start of randomization (week 0) to last trial-related participant-site contact (week 51).

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

    Time frame · Baseline (week 0), week 44

    Registry description

    Change in LDL measured as milligrams per deciliter (mg/dL) from baseline (week 0) to week 44 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 the start of randomization (week 0) to last trial-related participant-site contact (week 51).

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

    Time frame · Baseline (week 0), week 44

    Registry description

    Change in VLDL measured as milligrams per deciliter (mg/dL) from baseline (week 0) to week 44 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 the start of randomization (week 0) to last trial-related participant-site contact (week 51).

  20. Change From Baseline in Free Fatty Acids-Ratio to Baseline

    Time frame · Baseline (week 0), week 44

    Registry description

    Change in free fatty acids measured as milligrams per deciliter (mg/dL) from baseline (week 0) to week 44 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 the start of randomization (week 0) to last trial-related participant-site contact (week 51).

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 44

Change From Baseline in Body Weight (Percentage [%])

GroupValue (Percentage change)Spread
Semaglutide 2.4 mg-12.57.4
Placebo-3.65.9
Primary outcomeCount of participants· At week 44

Number of Participants Who Achieved Body Weight Reduction Greater Than or Equal (>=) to 5% (Yes/No)

GroupValue (Participants)
Semaglutide 2.4 mg203
Placebo36
Secondary and other outcome results(6)
Secondary outcomeCount of participants· At week 44

Number of Participants Who Achieved Body Weight Reduction Greater Than or Equal (>=) to 10% (Yes/No)

GroupValue (Participants)
Semaglutide 2.4 mg151
Placebo12
Secondary outcomeCount of participants· At week 44

Number of Participants Who Achieved Body Weight Reduction Greater Than or Equal (>=) to 15% (Yes/No)

GroupValue (Participants)
Semaglutide 2.4 mg82
Placebo7
Secondary outcomeMean· Baseline (week 0), week 44

Change From Baseline in Waist Circumference

GroupValue (Centimeter (cm))Spread
Semaglutide 2.4 mg-11.17.2
Placebo-3.85.8
Secondary outcomeMean· Baseline (week 0), week 44

Change From Baseline in Body Weight (Kilogram [kg])

GroupValue (Kilogram (kg))Spread
Semaglutide 2.4 mg-11.97.3
Placebo-3.46.0
Secondary outcomeMean· Baseline (week 0), week 44

Change From Baseline in Body Mass Index (BMI)

GroupValue (Kilograms per square meter (kg/m^2))Spread
Semaglutide 2.4 mg-4.32.6
Placebo-1.22.1
Secondary outcomeCount of participants· At week 44

Number of Participants Who Achieved Body Weight Reduction Greater Than or Equal (>=) to 20% (Yes/No)

GroupValue (Participants)
Semaglutide 2.4 mg34
Placebo2

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Sema 2.4 mgParticipants initiated at a once weekly dose of 0.25 mg semaglutide s.c. followed a fixed-dose escalation regimen, with dose increasing every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), to reach maintenance dose after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once-weekly for an additional 28 weeks until week 44 adjunct to a reduced calorie diet and increased physical activity.0 / 24914 / 249180 / 249
PlaceboParticipants received placebo matched to semaglutide s.c. once weekly for 44 weeks0 / 1268 / 12657 / 126

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

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2024

4 results

Efficacy and safety of once weekly semaglutide 2·4 mg for weight management in a predominantly east Asian population with overweight or obesity (STEP 7): a double-blind, multicentre, randomised controlled trial.

Mu et al. 2024The lancet. Diabetes & endocrinologycited by 102

PMID 38330988DOI 10.1016/s2213-8587(23)00388-1PUB-38330988

Full text at the publisher4 results
Publisher pageSee results (4)

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 18 years or older at the time of signing informed consent * History of at least one self-reported unsuccessful dietary effort to lose body weight For subjects without T2D at screening: * Body mass index (BMI) of : * greater than or equal to 30 kg/m\^2 * greater 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 For subjects with T2D at screening: * Diagnosed with T2D above or equal to 180 days prior to the day of screening * Treated with either: * diet and exercise alone or * stable treatment (same drug(s), dose and dosing frequency) for at least 60 days prior to the day of screening with up to 3 oral antidiabetic medications alone or in any combination (metformin, α-glucosidase inhibitor (AGI), SU, glinides, SGLT2i or glitazone) according to local label * HbA1c 7.0-10.0% (53-86 mmol/mol) (both inclusive) * BMI greater than or equal to 27 kg/m\^2 Exclusion Criteria: * A self-reported change in body weight above 5 kg (11 lbs) within 90 days before screening irrespective of medical records For subjects without T2D at screening: \- HbA1c equal to or above 6.5% (48 mmol/mol) as measured by the central laboratory at screening For subjects with T2D at screening : * Renal impairment measured as estimated Glomerular Filtration Rate (eGFR) value of below 30 mL/min/1.73 m\^2 (below 60 mL/min/1.73 m\^2 in subjects treated with SGLT2i) according to CKDEPI creatinine equation as defined by KDIGO 2012 by the central laboratory at screening * Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 90 days prior to screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.

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