Bimagrumab in obese patients with type 2 diabetes
Research type
Research Study
Full title
A randomized, subject- and investigator-blinded, placebo-controlled study to assess the safety, pharmacokinetics and efficacy of intravenous bimagrumab in overweight and obese patients with type 2 diabetes
IRAS ID
226279
Contact name
Annelize Koch
Contact email
Sponsor organisation
Novartis Pharma Services AG
Eudract number
2016-004124-26
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 3 months, 3 days
Research summary
The study will investigate how a 48 week treatment period with intravenous bimagrumab works to reduce total fat body mass in obese patients with type 2 diabetes. This is measured using imaging techniques (DXA scan), blood sample analysis, body measurements, patient questionnaires and muscle function tests. For patients who consent for the optional MRI, the liver, visceral and subcutaneous fat content will be assessed.
Bimagrumab is a monoclonal antibody and is known to bind to Activin type 2 receptors (ActRII) in the body. Blocking ActRII is known to increase skeletal muscle mass and is hypothesized to improve insulin sensitivity. Inhibiting ActRII has been shown to reduce fat tissue in mice and in previous human studies bimagrumab resulted in a reduction in fat mass, an increase in lean mass and improved insulin sensitivity. This study is designed to evaluate these effects in obese patients with type 2 diabetes.
This study is subject and investigator blinded which means that participants and the doctors/nurses treating them will not know which treatment they have been randomly assigned (bimagrumab or placebo). Eligible subjects will be randomized in a 1:1 ratio to bimagrumab or placebo.
This is a parallel study which means that subjects receiving bimagrumab or placebo will do so at roughly the same time.
Subjects will have 12 blinded 4-weekly intravenous infusions, then an 8 week follow-up period.
Subjects will be on study for approximately 14 months and the aim is to recruit 8 patients in the one UK site (approximately 60 patients are planned to be enrolled in total globally).REC name
Wales REC 2
REC reference
17/WA/0274
Date of REC Opinion
16 Sep 2017
REC opinion
Favourable Opinion