Phase 3
N=375
Research Study of How Well Semaglutide Works in People Living With Overweight or Obesity.
Overweight · Obesity · Diabetes Mellitus, Type 2
Bottom Line
View on ClinicalTrials.gov: NCT04251156 ↗Enrolled (actual)
375
Serious AEs
5.9%
Results posted
Nov 2024
Primary outcome: Primary: Change From Baseline in Body Weight (Percentage [%]) — -12.5; -3.6 Percentage change — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Semaglutide (Drug); Placebo (semaglutide) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novo Nordisk A/S
- Primary completion
- Aug 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Body Weight (Percentage [%]) |
-12.5; -3.6 | <0.0001 sig |
| PRIMARY Number of Participants Who Achieved Body Weight Reduction Greater Than or Equal (>=) to 5% (Yes/No) |
203; 36; 35; 80 | <0.0001 sig |
| SECONDARY Number of Participants Who Achieved Body Weight Reduction Greater Than or Equal (>=) to 10% (Yes/No) |
151; 12; 87; 104 | — |
| SECONDARY Number of Participants Who Achieved Body Weight Reduction Greater Than or Equal (>=) to 15% (Yes/No) |
82; 7; 156; 109 | — |
| SECONDARY Change From Baseline in Waist Circumference |
-11.1; -3.8 | — |
| SECONDARY Change From Baseline in Body Weight (Kilogram [kg]) |
-11.9; -3.4 | — |
| SECONDARY Change From Baseline in Body Mass Index (BMI) |
-4.3; -1.2 | — |
| SECONDARY Number of Participants Who Achieved Body Weight Reduction Greater Than or Equal (>=) to 20% (Yes/No) |
34; 2; 204; 114 | — |
| SECONDARY Change From Baseline in Systolic Blood Pressure |
-7; -2 | — |
| SECONDARY Change From Baseline in Short Form-36 (SF-36) - Physical Functioning Score |
1.3; 0.2 | — |
| SECONDARY 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 |
8.0; 2.3 | — |
| SECONDARY Change From Baseline in Glycosylated Haemoglobin (HbA1c) (Percentage [%]) |
-0.8; -0.1 | — |
| SECONDARY Change From Baseline in HbA1c (Millimoles Per Mole [mmol/Mol]) |
-8.9; -1.3 | — |
| SECONDARY Change From Baseline in Fasting Plasma Glucose (FPG) (Milligrams Per Deciliter [mg/dL]) |
-18.9; -1.1 | — |
| SECONDARY Change From Baseline in FPG (Millimoles Per Liter [mmol/L]) |
-1.1; -0.1 | — |
| SECONDARY Change From Baseline in Fasting Serum Insulin: Ratio to Baseline |
0.76; 0.98 | — |
| SECONDARY Change From Baseline in Diastolic Blood Pressure |
-4; -1 | — |
| SECONDARY Change From Baseline in Total Cholesterol: Ratio to Baseline |
0.94; 1.04 | — |
| SECONDARY Change From Baseline in High-Density Lipoproteins (HDL)-Ratio to Baseline |
1.05; 1.08 | — |
| SECONDARY Change From Baseline in Low-Density Lipoproteins (LDL)-Ratio to Baseline |
0.97; 1.04 | — |
| SECONDARY Change From Baseline in Very Low-Density Lipoproteins (VLDL)-Ratio to Baseline |
0.71; 0.96 | — |
| SECONDARY Change From Baseline in Free Fatty Acids-Ratio to Baseline |
0.91; 1.05 | — |
| SECONDARY Change From Baseline in Triglycerides-Ratio to Baseline |
0.71; 0.96 | — |
| SECONDARY Change From Baseline in SF-36 All Domains (Except Physical Functioning) and 2 Component Summary Scores |
0.5; -0.8; -0.3; -1.2; 3.2; 1.6 | — |
| SECONDARY Change From Baseline in IWQOL-Lite for Physical Domain Score, Psychological Domain Score and Total Score |
7.2; 2.0; 12.0; 4.8; 10.3; 3.8 | — |
| SECONDARY Number of Participants Who Achieved Responder Definition Value for SF-36 Physical Functioning Score (Yes/No) |
69; 27; 168; 89 | — |
| SECONDARY Number of Participants Who Achieved Responder Definition Value For IWQoL-Lite for CT Physical Function (5-items) Score (Yes/No) |
83; 22; 153; 93 | — |
| SECONDARY Number of Participants With Type 2 Diabetes (T2D) Who Achieved HbA1c Less Than (<) 7.0 Percent (%) (53 mmol/Mol) |
57; 8; 5; 20 | — |
| SECONDARY Number of Participants With T2D Who Achieved HbA1c Less Than or Equal to (<=) 6.5% (48 mmol/Mol) |
51; 4; 11; 24 | — |
| SECONDARY Change From Baseline in Glycaemic Category (Normo-Glycaemia, Pre-Diabetes, T2D) in Participants With no T2D at Baseline |
158; 53; 15; 29; 0; 2 | — |
| SECONDARY Change From Baseline in Number of Participants With Antihypertensive Medication (Decrease, No Change, Increase) |
8; 2; 57; 23; 9; 4 | — |
| SECONDARY Change From Baseline in Number of Participants With Lipid-Lowering Medication (Decrease, No Change, Increase) |
3; 1; 31; 13; 1; 4 | — |
| SECONDARY Change From Baseline in Number of Participants With Concomitant Oral Antidiabetic Medication (Decrease, No Change, Increase) in Participants With No T2D at Baseline |
16; 2; 35; 16; 1; 6 | — |
| SECONDARY Change From Baseline in Number of Participants in Fatty Liver Index (FLI) Score Category |
67; 8; 62; 17; 107; 88 | — |
| SECONDARY Number of Participants Who From Randomization Permanently Discontinued Randomized Trial Product |
18; 16 | — |
| SECONDARY Time to Permanent Discontinuation of Randomized Trial Product (Weeks) |
16.7; 18.8 | — |
| SECONDARY Number of Treatment Emergent Adverse Events (TEAEs) |
1122; 415 | — |
| SECONDARY Number of Serious Adverse Events (SAEs) |
14; 8 | — |
| SECONDARY Number of Treatment Emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemia Episodes (Yes/No) in Participants With T2D at Week 0 |
2; 1 | — |
| SECONDARY Change From Baseline in Pulse |
4; 1 | — |
| SECONDARY Change From Baseline in Amylase: Ratio to Baseline |
1.19; 1.08 | — |
| SECONDARY Change From Baseline in Lipase: Ratio to Baseline |
1.54; 1.08 | — |
| SECONDARY Change From Baseline in Calcitonin: Ratio to Baseline |
1.04; 0.92 | — |
Summary
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT04251156). 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.