Phase 2
Completed N=957
Investigation of Safety and Efficacy of Once-daily Semaglutide in Obese Subjects Without Diabetes Mellitus
Metabolism and Nutrition Disorder · Obesity
Source: ClinicalTrials.gov NCT02453711 ↗
Enrolled (actual)
957
Serious AEs
7.6%
Results posted
Apr 2020
Primary outcomePrimary: Relative Change in Body Weight (%) — -5.99; -8.62; -11.60; -11.17 Percentage (%) of body weight — p==0.0055
Summary
This trial is conducted globally. The aim of this trial is to investigate safety and efficacy of once-daily semaglutide in obese subjects without diabetes mellitus.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Relative Change in Body Weight (%) |
-5.99; -8.62; -11.60; -11.17; -13.84; -11.38 | =0.0055 sig |
| SECONDARY Participants With Weight Loss of ≥5% of Baseline Body Weight |
53.50; 67.49; 74.91; 80.52; 82.52; 72.19 | — |
| SECONDARY Participants With Weight Loss of ≥10% of Baseline Body Weight |
18.94; 36.57; 55.95; 57.76; 64.61; 58.45 | — |
| SECONDARY Change in Body Weight (kg) |
-6.66; -9.34; -12.30; -12.45; -15.15; -12.54 | — |
| SECONDARY Change in Waist Circumference |
-6.11; -8.75; -11.02; -10.91; -12.31; -11.06 | — |
| SECONDARY Change in Waist to Hip Circumference Ratio |
-0.01; -0.02; -0.02; -0.03; -0.02; -0.02 | — |
| SECONDARY Change in BMI |
-2.37; -3.36; -4.38; -4.40; -5.40; -4.48 | — |
| SECONDARY Change in HbA1c |
-0.13; -0.21; -0.28; -0.23; -0.29; -0.25 | — |
| SECONDARY Change in FPG |
-0.29; -0.35; -0.40; -0.39; -0.43; -0.38 | — |
| SECONDARY Change in Glycaemic Category (Normoglycaemia, Pre-diabetes, T2D) |
— | — |
| SECONDARY Change in SBP |
-4.46; -5.76; -6.26; -6.41; -5.81; -6.07 | — |
| SECONDARY Change in DBP |
-2.55; -2.65; -4.09; -2.98; -3.61; -2.20 | — |
| SECONDARY Change in Lipids (Total Cholesterol, LDL Cholesterol, HDL Cholesterol, VLDL Cholesterol, Triglycerides and FFA) |
0.96; 0.95; 0.93; 0.93; 0.93; 0.93 | — |
| SECONDARY Change in hsCRP |
0.71; 0.65; 0.57; 0.66; 0.54; 0.58 | — |
| SECONDARY Change in IWQoL Lite |
— | — |
| SECONDARY Change in SF-36 |
1.85; 3.01; 4.27; 3.82; 5.16; 1.88 | — |
| SECONDARY Participants With Change in Concomitant Medications (Antihypertensive and Lipid-lowering Medications) |
37; 31; 28; 31; 36; 32 | — |
| SECONDARY Compliance With Nutritional Counselling |
6.85; 7.30; 7.17; 7.07; 7.20; 7.05 | — |
| SECONDARY Number of AEs During the Trial |
547; 730; 738; 587; 775; 737 | — |
| SECONDARY Number of Hypoglycaemic Episodes During the Trial |
1; 6; 4; 8; 10; 20 | — |
| SECONDARY Number of New and Ongoing Nausea, Vomiting, Diarrhoea, and Constipation Events by Week |
41; 80; 74; 69; 94; 106 | — |
| SECONDARY Nausea: Individual Scores of Nausea Questionnaire and Severity by NRS Score |
0; 1; 0; 0; 0; 0 | — |
| SECONDARY Change in ECG |
70; 69; 74; 62; 62; 70 | — |
| SECONDARY Change in Pulse |
-0.33; 3.46; 1.88; 2.38; 2.54; 2.34 | — |
| SECONDARY Change in Haematology: Haemoglobin |
0.01; -0.08; -0.02; -0.07; 0.00; -0.07 | — |
| SECONDARY Change in Haematology: Haematocrit |
-0.25; -0.58; -0.42; -0.49; -0.31; -0.68 | — |
| SECONDARY Change in Haematology: Thrombocytes, Leucocytes and Differential Count |
-2.08; 2.95; -8.17; 2.79; -0.52; -5.76 | — |
| SECONDARY Change in Haematology: Erythrocytes |
-0.01; -0.06; -0.03; -0.04; -0.01; -0.04 | — |
| SECONDARY Change in Biochemistry: Creatinine and Bilirubin (Total) |
-1.14; -0.85; -1.09; 0.76; 1.48; 1.05 | — |
| SECONDARY Change in Biochemistry: Creatinine Kinase, Amylase, Lipase, ALT, AST and ALP |
0.53; -44.75; -13.20; -46.34; -29.91; -8.86 | — |
| SECONDARY Change in Biochemistry: Urea, Sodium, Potassium and Calcium (Total) |
-0.04; 0.16; -0.01; -0.10; -0.00; -0.06 | — |
| SECONDARY Change in Biochemistry: Albumin |
0.03; 0.01; 0.07; 0.05; 0.03; 0.01 | — |
| SECONDARY Change in Biochemistry: Calcitonin |
0.08; 0.03; 0.04; 0.04; 0.17; -0.01 | — |
| SECONDARY Change in Biochemistry: TSH |
-0.31; -0.10; -0.22; -0.18; -0.10; -0.12 | — |
| SECONDARY Change in Mental Health Assessed by C-SSRS |
0; 0; 1; 2; 1; 0 | — |
| SECONDARY Change in Mental Health Assessed by PHQ-9 |
2.5; 1.7; 2.1; 1.5; 2.5; 1.7 | — |
| SECONDARY Anti-semaglutide Antibodies During and After Treatment |
0; 0; 0; 0; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria: - Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial - Male or female, age 18 years or older at the time of signing inform consent - Body mass index (BMI) equal or above 30.0 kg/m^2 at the screening visit - At least one unsuccessful weight loss attempt per investigator judgement Exclusion Criteria: - A HbA1c (glycosylated haemoglobin) equal to or above 6.5% at screening or diagnosed with type 1 or type 2 diabetes mellitus - Treatment with glucose lowering agent(s) within 90 days before screening - Screening calcitonin equal to or above 50 ng/L (pg/mL) - Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2 - History of pancreatitis (acute or chronic) - Obesity induced by endocrine disorders (e.g. Cushing Syndrome) - Treatment with any medication within 90 days before screening that based on investigator's judgement may cause significant weight change - Previous surgical treatment for obesity (liposuction and/or abdominoplasty performed 1 year before screening is allowed) - History of major depressive disorder within 2 years before randomisation - Any lifetime history of a suicidal attempt - Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using an adequate contraceptive method (adequate contraceptive measures as required by local regulation or practice)
Data sourced from ClinicalTrials.gov (NCT02453711). 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.