Phase 3 · Semaglutide

STEP7 trial results

Effect and Safety of Semaglutide 2.4 mg Once-weekly on Weight Management in Subjects With Overweight or Obesity.

Change From Baseline in Body Weight (Percentage [%]) (Percentage change), Baseline (week 0), week 44. Semaglutide 2.4 mg: -12.5; Placebo: -3.6.

Participants
375
Status
completed
Completed
2022-08-23
Sponsor
Novo Nordisk A/S

As posted on ClinicalTrials.gov (NCT04251156), updated at source Jan 29, 2026. Read again whenever the registry updates it. Registry figures can differ from a published paper, which may use another analysis.

Primary outcome

What STEP7 measured first

Change From Baseline in Body Weight (Percentage [%])Percentage change · Baseline (week 0), week 44 · mean
Semaglutide 2.4 mgn=238Placebon=116
-12.5(7.4)-3.6(5.9)
Number of Participants Who Achieved Body Weight Reduction Greater Than or Equal (>=) to 5% (Yes/No)Participants · At week 44 · count of participants
MeasureSemaglutide 2.4 mgn=238Placebon=116
Yes20336
No3580
Side effects by arm

Side effects in STEP7

Percent of participants affected, Week 0 to week 51. The most common events the registry lists.

EventSema 2.4 mgPlacebo
Any serious event5.6%6.3%
Diarrhoea26.1%10.3%
Nausea24.1%7.1%
Upper respiratory tract infection20.5%20.6%
Decreased appetite17.3%4%
Constipation11.6%5.6%
Abdominal distension10%0.8%
Vomiting8.4%0%
Abdominal pain upper6%3.2%
Arthralgia6%2.4%
COVID-196%4%
Dyspepsia5.6%0%
Eructation5.6%0%
Abdominal pain5.2%2.4%
Dizziness5.2%4.8%
Secondary outcomes

What else it measured

Number of Participants Who Achieved Body Weight Reduction Greater Than or Equal (>=) to 10% (Yes/No)Participants · At week 44 · count of participants
MeasureSemaglutide 2.4 mgn=238Placebon=116
Yes15112
No87104
Number of Participants Who Achieved Body Weight Reduction Greater Than or Equal (>=) to 15% (Yes/No)Participants · At week 44 · count of participants
MeasureSemaglutide 2.4 mgn=238Placebon=116
Yes827
No156109
Change From Baseline in Waist CircumferenceCentimeter (cm) · Baseline (week 0), week 44 · mean
Semaglutide 2.4 mgn=238Placebon=116
-11.1(7.2)-3.8(5.8)
Change From Baseline in Body Weight (Kilogram [kg])Kilogram (kg) · Baseline (week 0), week 44 · mean
Semaglutide 2.4 mgn=238Placebon=116
-11.9(7.3)-3.4(6.0)
Change From Baseline in Body Mass Index (BMI)Kilograms per square meter (kg/m^2) · Baseline (week 0), week 44 · mean
Semaglutide 2.4 mgn=238Placebon=116
-4.3(2.6)-1.2(2.1)
Number of Participants Who Achieved Body Weight Reduction Greater Than or Equal (>=) to 20% (Yes/No)Participants · At week 44 · count of participants
MeasureSemaglutide 2.4 mgn=238Placebon=116
Yes342
No204114
Change From Baseline in Systolic Blood PressureMillimeters of mercury (mmHg) · Baseline (week 0), week 44 · mean
Semaglutide 2.4 mgn=238Placebon=116
-7(12)-2(12)
Change From Baseline in Short Form-36 (SF-36) - Physical Functioning ScoreScore on a scale · Baseline (week 0), week 44 · mean
Semaglutide 2.4 mgn=237Placebon=116
1.3(4.7)0.2(5.7)
Change From Baseline in Impact of Weight on Quality of Life-Lite for Clinical Trials (IWQOL-Lite for CT) - Physical Function Domain (5-items) ScoreScore on a scale · Baseline (week 0), week 44 · mean
Semaglutide 2.4 mgn=236Placebon=115
8.0(16.4)2.3(18.5)
Change From Baseline in Glycosylated Haemoglobin (HbA1c) (Percentage [%])Percentage of HbA1c · Baseline (week 0), week 44 · mean
Semaglutide 2.4 mgn=235Placebon=111
-0.8(0.8)-0.1(0.8)
Change From Baseline in HbA1c (Millimoles Per Mole [mmol/Mol])Millimoles per mole (mmol/mol) · Baseline (week 0), week 44 · mean
Semaglutide 2.4 mgn=235Placebon=111
-8.9(9.2)-1.3(8.3)
Change From Baseline in Fasting Plasma Glucose (FPG) (Milligrams Per Deciliter [mg/dL])Milligrams per deciliter (mg/dL) · Baseline (week 0), week 44 · mean
Semaglutide 2.4 mgn=234Placebon=112
-18.9(25.3)-1.1(18.7)
The trial

How STEP7 was run

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.

  • Semaglutide: Once-weekly injections of gradually increased doses of semaglutide
  • Placebo (semaglutide): Once-weekly injections of gradually increased doses of semaglutide placebo
Who could join the trial

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.

Published papers

Papers from STEP7

Trial averages do not predict what one person will experience. Results are shown as the registry posts them, without interpretation.

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