Research study investigating how well semaglutide works in people suffering from overweight or obesity

Phase 1

Conditions: Obesity
MedDRA version: 20.0Level: PTClassification code 10029883Term: ObesitySystem Organ Class: 10027433 - Metabolism and nutrition disorders
Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

Registration Number: EUCTR2017-003436-36-FI

Lead Sponsor: ovo Nordisk A/S

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 1950

Inclusion Criteria

1. Male or female, age = 18 years at the time of signing informed consent
2. Body mass index (BMI) = 30 kg/sqm or = 27 kg/sqm with the presence of at least one of the following weight-related comorbidities (treated or untreated): hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease
3. History of at least one self-reported unsuccessful dietary effort to lose body weight
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 1560
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 390

Exclusion Criteria

1. HbA1C = 48 mmol/mol (6.5%) as measured by the central laboratory at screening
2. A self-reported change in body weight > 5 kg (11 lbs) within 90 days before screening irrespective of medical records

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare the effect of semaglutide s.c. 2.4 mg once-weekly versus semaglutide placebo as an adjunct to a reduced-calorie diet and increased physical activity in subjects with overweight or obesity on body weight;Secondary Objective: 1. To compare the effect of semaglutide s.c. 2.4 mg once-weekly versus semaglutide placebo as an adjunct to a reduced-calorie diet and increased physical activity in subjects with overweight or obesity on:<br>- Cardiovascular risk factors<br>- Clinical Outcome Assessments (COAs)<br>2. To compare the safety and tolerability of semaglutide s.c. 2.4 mg once-weekly versus semaglutide placebo as an adjunct to a reduced-calorie diet and increased physical activity in subjects with overweight or obesity;Primary end point(s): 1. Change in body weight (%)<br>2. Subjects who achieve body weight reduction = 5% (yes/no);Timepoint(s) of evaluation of this end point: 1. From baseline at week 0 to week 68 <br>2. After 68 weeks from baseline at week 0

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1. Subjects who achieve (yes/no):<br>- Body weight reduction = 10% <br>- Body weight reduction = 15% <br>2. Change in:<br>- Waist circumference (cm)<br>- Systolic blood pressure (mmHg)<br>- Physical functioning score (SF-36)<br>- Physical function domain (5-items) score (IWQoL-Lite for CT);Timepoint(s) of evaluation of this end point: 1. After 68 weeks from baseline at week 0<br>2. From baseline at week 0 to week 68

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