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

Phase 1

• Conditions: Obesity; MedDRA version: 20.0 Level: PT Classification code 10029883 Term: Obesity System Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2017-003436-36-GB
• Lead Sponsor: ovo Nordisk A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-02-12
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• 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