Investigation of safety and efficacy of once-daily semaglutide in obese subjects without diabetes mellitus

Phase 1

Conditions: Obesity
MedDRA version: 19.0Level: PTClassification code 10029883Term: ObesitySystem Organ Class: 10027433 - Metabolism and nutrition disorders
Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

Registration Number: EUCTR2014-001540-38-DE

Lead Sponsor: ovo Nordisk A/S

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 935

Inclusion Criteria

1. 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
2. Male or female, age = 18 years at the time of signing inform consent
3. Body mass index (BMI) = 30.0 kg/m^2 at the screening visit
4. At least one unsuccessful weight loss attempt per investigator judgement
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 885
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

Exclusion Criteria

1. A HbA1c = 6.5% at screening or diagnosed with type 1 or type 2 diabetes mellitus
2. Treatment with glucose lowering agent(s) within 90 days before screening
3. Screening calcitonin = 50 ng/L (pg/mL)
4. Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2
5. History of pancreatitis (acute or chronic)
6. Obesity induced by endocrine disorders (e.g. Cushing Syndrome)
7.Treatment with any medication within 90 days before screening that based on investigator’s judgement may cause significant weight change
8. Previous surgical treatment for obesity (liposuction and/or abdominoplasty performed > 1 year before screening is allowed)
9. History of major depressive disorder within 2 years before randomisation
10. Any lifetime history of a suicidal attempt
11. 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)

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess and compare the dose-response of five doses of once-daily semaglutide versus placebo in inducing and maintaining weight loss after 52 weeks in obese subjects without diabetes mellitus;Secondary Objective: 1. To compare the effect of once-daily semaglutide versus once-daily liraglutide 3.0 mg in inducing and maintaining weight loss after 52 weeks in obese subjects without diabetes mellitus<br>2. To compare the effects of once-daily semaglutide to placebo and once-daily liraglutide 3.0 mg on:<br>– Glucose metabolism parameters;Primary end point(s): Relative change from baseline in body weight (%) ;Timepoint(s) of evaluation of this end point: At 52 weeks

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1. Proportion (%) of subjects with weight loss of = 5% of baseline body weight <br>2. Proportion (%) of subjects with weight loss of = 10% of baseline body weight<br>Change in other parameters of weight loss:<br>3. Body weight (kg)<br>Change in glucose metabolism parameters:<br>4. Glycosylated haemoglobin (HbA1c)<br>5. Fasting plasma glucose (FPG);Timepoint(s) of evaluation of this end point: 1 + 2: At 52 weeks<br>3 + 4 + 5: From baseline to 52 weeks