STEP 5: Two-year research study investigating how well semaglutide works in people suffering from overweight or obesity

Phase 1

• Conditions: ObesityOverweight; MedDRA version: 20.0Level: PTClassification code 10029883Term: ObesitySystem Organ Class: 10027433 - Metabolism and nutrition disorders; MedDRA version: 20.0Level: PTClassification code 10033307Term: OverweightSystem Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2017-003726-32-ES
• Lead Sponsor: ovo Nordisk A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-06-27
• Study Completion: 2021-03-23
• Last Update Posted: 19 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 304

Inclusion Criteria

1. Male or female, age 18 years or older at the time of signing informed consent
2. Body mass index (BMI) equal to or above 30 kg/sqm or equal to or above 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 270
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

1. HbA1c equal to or above 48 mmol/mol (6.5%) as measured by the central laboratory at screening
2. A self-reported change in body weight above 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