1404-0036 Phase II BI 456906 dose finding in obesity or overweight
Research type
Research Study
Full title
A Phase II, randomized, double blind, parallel group,46 weeks dose-finding study of BI 456906 administered once weekly subcutaneously compared with placebo in patients with obesity or overweight
IRAS ID
289246
Contact name
John Wilding
Contact email
Eudract number
2020-002479-37
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 11 months, 5 days
Research summary
This study is to test whether different doses of BI456906 given once a week subcutaneously, could help people who are overweight or obese. It is randomized, double blind, parallel group, 46 week dose finding study, compared to placebo. Participants, male or female aged 18-75years who meet the inclusion criteria will be randomly assigned to one of 4 active dose arms or placebo arm. A different dose escalation will apply to each active arm. The overall purpose of the trial is to assess the efficacy on weight loss and maintenance and tolerability of the 4 different doses of BI456906 compared to placebo, with the results serving as proof of concept and to select the target dose for future clinical development of BI456906.\nParticipation in the trial will approximately a year and require approximately 21 visits to the trial clinic. Each patient will have physical examinations, ECG’s, various blood tests,diet and physical activity counselling. The patient will need to complete an provided, e-diary to record level of activity and dietary compliance.
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
21/NW/0020
Date of REC Opinion
18 Mar 2021
REC opinion
Further Information Favourable Opinion