Phase 3
Completed N=401
STEP 6: Research Study Investigating How Well Semaglutide Works in People Living With Overweight or Obesity
Source: ClinicalTrials.gov NCT03811574 ↗Enrolled (actual)
401
Serious AEs
6.0%
Results posted
Mar 2022
Primary outcomePrimary: Change in Body Weight (%) — -9.9; -13.4; -1.9 Percentage change — p=<.0001
◆ Published Evidence
Highly cited
1,262citations · ~252 / year
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.
Summary
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.
Linked Publications (3)
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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.
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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.
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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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Body Weight (%) |
-9.9; -13.4; -1.9 | <.0001 sig |
| PRIMARY Number of Participants Who Achieve (Yes/no): Body Weight Reduction More Than or Equal to 5% |
71; 160; 21; 27; 33; 79 | <.0001 sig |
| SECONDARY Number of Participants Who Achieve (Yes/no): Body Weight Reduction More Than or Equal to 10% |
41; 117; 5; 57; 76; 95 | — |
| SECONDARY Number of Participants Who Achieve (Yes/no): Body Weight Reduction More Than or Equal to 15% |
24; 79; 3; 74; 114; 97 | — |
| SECONDARY Number of Participants Who Achieve (Yes/no): Body Weight Reduction More Than or Equal to 20% |
11; 38; 2; 87; 155; 98 | — |
| SECONDARY Change in Waist Circumference Measured Midway Between the Lower Rib Margin and the Iliac Crest |
-7.8; -11.2; -1.8 | — |
| SECONDARY Change in Waist Circumference Measured According to the JASSO (Japan Society for the Study of Obesity) Guideline |
-7.6; -10.2; -1.9 | — |
| SECONDARY Change in Body Weight (Kg) |
-8.3; -11.3; -1.7 | — |
| SECONDARY Change in Body Mass Index (BMI) |
-3.1; -4.3; -0.6 | — |
| SECONDARY Change in Visceral Fat Area (VFA) (%) |
-22.3; -41.0; -7.1 | — |
| SECONDARY Change in Visceral Fat Area (VFA) Centimeter Square (cm^2) |
-41.7; -67.4; -13.8 | — |
| SECONDARY Change in HbA1c (%) |
-0.9; -1.0; 0.0 | — |
| SECONDARY Change in HbA1c (mmol/Mol) |
-9.9; -10.6; -0.1 | — |
| SECONDARY Change in Fasting Plasma Glucose |
-18.3; -19.3; 1.7 | — |
| SECONDARY Change in Fasting Serum Insulin-ratio to Baseline |
0.85; 0.71; 0.89 | — |
| SECONDARY Change in Systolic Blood Pressure |
-12; -11; -5 | — |
| SECONDARY Change in Diastolic Blood Pressure |
-5; -5; -3 | — |
| SECONDARY Change in Total Cholesterol-ratio to Baseline |
0.93; 0.91; 1.00 | — |
| SECONDARY Change in High-density Lipoproteins (HDL)-Ratio to Baseline |
1.06; 1.08; 1.06 | — |
| SECONDARY Change in Low-density Lipoproteins (LDL)-Ratio to Baseline |
0.90; 0.86; 0.95 | — |
| SECONDARY Change in Very Low-density Lipoproteins (VLDL)-Ratio to Baseline |
0.79; 0.79; 1.05 | — |
| SECONDARY Change in Free Fatty Acids-ratio to Baseline |
1.04; 0.96; 1.28 | — |
| SECONDARY Change in Triglycerides-ratio to Baseline |
0.78; 0.79; 1.05 | — |
| SECONDARY Change in High Sensitivity C-reactive Protein (hsCRP)-Ratio to Baseline |
0.64; 0.39; 0.92 | — |
| SECONDARY Change in Plasminogen Activator Inhibitor-1 Activity-ratio to Baseline |
0.83; 0.68; 1 | — |
| SECONDARY Change in Short Form 36 v2.0 Acute (SF-36) Score |
0.0; 1.0; -0.5; -1.6; -0.2; 0.3 | — |
| SECONDARY Change in Impact of Weight on Quality of Life-lite for Clinical Trials (IWQOL-Lite for CT) Score |
2.6; 4.9; 0.5; 1.9; 4.2; -0.8 | — |
| SECONDARY Number of Participants Who Achieve (Yes/no): Responder Definition Value for SF-36 Physical Functioning Score |
19; 43; 13; 79; 149; 87 | — |
| SECONDARY Number of Participants Who Achieve (Yes/no): Responder Definition Value for IWQoL-Lite for CT Physical Function (5-items) Score |
19; 49; 11; 79; 143; 89 | — |
| SECONDARY Number of Participants Who Achieved (Yes/no): HbA1c <7.0% (53 mmol/Mol) |
24; 43; 1; 1; 6; 24 | — |
| SECONDARY Number of Participants Who Achieved (Yes/no): HbA1c ≤6.5% (48 mmol/Mol) |
22; 40; 1; 3; 9; 24 | — |
| SECONDARY Number of Treatment-emergent AEs |
483; 834; 235 | — |
| SECONDARY Number of Serious Adverse Events |
10; 12; 7 | — |
| SECONDARY Number of Treatment Emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemia Episodes |
0; 0; 0 | — |
| SECONDARY Change in Pulse |
6; 4; 2 | — |
| SECONDARY Change in Amylase: Ratio to Baseline |
1.09; 1.08; 0.93 | — |
| SECONDARY Change in Lipase: Ratio to Baseline |
1.56; 1.56; 0.96 | — |
| SECONDARY Change in Calcitonin: Ratio to Baseline |
0.98; 0.95; 0.94 | — |
| SECONDARY Change in QTCF Interval |
-2.2; -2.5; 5.6 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03811574) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.