Phase 3
N=242
A Research Study to See How Well Semaglutide Helps People Who Have a Body Weight Above the Healthy Weight Range
Overweight · Obesity
Bottom Line
View on ClinicalTrials.gov: NCT06041217 ↗Enrolled (actual)
242
Serious AEs
6.6%
Results posted
May 2026
Primary outcome: Primary: Change in Body Weight (%) — -12.2; -2.2 Percentage change in body weight — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Semaglutide (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novo Nordisk A/S
- Primary completion
- Apr 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Body Weight (%) |
-12.2; -2.2 | <0.0001 sig |
| PRIMARY Number of Participants Who Achieved Body Weight Reduction Greater Than or Equal to (≥) 5% (Yes/No) |
128; 19; 31; 59 | <0.0001 sig |
| SECONDARY Number of Participants Who Achieved Body Weight Reduction ≥ 10% (Yes/No) |
96; 9; 63; 69 | — |
| SECONDARY Change in Waist Circumference |
-9.1; -2.4 | — |
| SECONDARY Change in Body Weight (kg) |
-9.3; -1.7 | — |
| SECONDARY Change in Body Mass Index |
-3.4; -0.6 | — |
| SECONDARY Change in Waist-height Ratio (WtHR) |
-0.05; -0.01 | — |
| SECONDARY Change in Systolic Blood Pressure |
-7; -4 | — |
| SECONDARY Change in Diastolic Blood Pressure |
-4; -2 | — |
| SECONDARY Change in Total Cholesterol (mmol/L) - Ratio to Baseline |
0.94; 1.01 | — |
| SECONDARY Change in High Density Lipoprotein (HDL) Cholesterol (mmol/L) - Ratio to Baseline |
1.04; 1.06 | — |
| SECONDARY Change in Low Density Lipoprotein (LDL) Cholesterol (mmol/L) - Ratio to Baseline |
0.97; 1.02 | — |
| SECONDARY Change in Very Low-Density Lipoproteins (VLDL) Cholesterol (mmol/L) - Ratio to Baseline |
0.72; 0.93 | — |
| SECONDARY Change in Triglycerides (mmol/L) - Ratio to Baseline |
0.71; 0.91 | — |
| SECONDARY Change in Free Fatty Acids (mmol/L) - Ratio to Baseline |
0.88; 0.99 | — |
| SECONDARY Change in High Sensitivity C-Reactive Protein (hsCRP) - Ratio to Baseline |
0.69; 0.68 | — |
| SECONDARY Change in HbA1c (%) |
-0.4; 0.0 | — |
| SECONDARY Change in HbA1c (mmol/Mol) |
-4.2; 0.5 | — |
| SECONDARY Change in Fasting Plasma Glucose (mg/dL) |
-12.3; 0.5 | — |
| SECONDARY Change in Fasting Plasma Glucose (mmol/L) |
-0.7; 0.0 | — |
| SECONDARY Number of Treatment Emergent Adverse Events (TEAEs) |
614; 183 | — |
| SECONDARY Number of Serious Adverse Events (SAEs) |
14; 3 | — |
| SECONDARY Change in Pulse |
3; 1 | — |
| SECONDARY Number of Clinically Significant Hypoglycaemic Episodes (Level 2) Less Than (<) 3.0 mmol/L Confirmed by Blood Glucose (BG) Meter - Participants With Type 2 Diabetes (T2D) |
1; 0 | — |
Summary
This study will look at how the investigational dose of semaglutide works in helping people with excess body weight, to lose weight. This study will compare the weight loss in people taking semaglutide to people taking "dummy" medicine (placebo). The study will last for about 1 year. The participants will have 12 visits at the clinic and 3 remote visits by phone calls with the study doctor or staff.
Eligibility Criteria
Inclusion Criteria
- Age greater than or equal to 18 years at the time of signing informed consent.
- Body mass index (BMI) of greater than or equal to 24 and less than 28 kilogram per square meter ( kg/m^2) with the presence of at least one weight related complication (treated or untreated): Type 2 diabetes (T2D), hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease or BMI greater than or equal to 28 and less 30 kg/m^2, with or without weight related complications at screening.
- History of at least one self-reported unsuccessful dietary effort to lose body weight.
For participants with T2D at screening:
- Diagnosed with T2D greater than or equal to 180 days prior to the day of screening
Treated with either:
- Diet and exercise alone or with 1-3 marketed oral antidiabetic drugs (metformin, alpha glucosidase, Sulfonylureas (SU), glinides, sodium-glucose co-transporter 2 inhibitors (SGLT2i) or glitazone as a single agent or in combination) according to local label.
- Treatment with oral anti-diabetic drugs should be stable (same drug(s) or active ingredient, dose, and dosing frequency) for at least 60 days before screening
- Glycated haemoglobin (HbA1c) of less than or equal to 10.0 percent (less than or equal to 86 millimoles per mol [mmol/mol]) as measured by the central laboratory at screening.
Exclusion Criteria
- A self-reported change in body weight greater than 5 kilograms (kg) within 90 days before screening irrespective of medical records.
- Treatment with any medication for the indication of obesity within the past 90 days before screening.
- Personal or first-degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma.
For participants without T2D at screening:
- HbA1c greater than or equal to 6.5percent (48 mmol/mol) as measured by the laboratory.
For participants with T2D at screening:
- Renal impairment with estimated Glomerular Filtration Rate (eGFR) value of less than 30 milliliter per minute per 1.73 square meter (mL/min/1.73 m^2) according to Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation as defined by Kidney Disease Improving Global Outcomes (KDIGO) 2012 classification 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.
Data sourced from ClinicalTrials.gov (NCT06041217). 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.