4433: NNC0174-0833 for weight management
Research type
Research Study
Full title
Investigation of safety and efficacy of NNC0174-0833 for weight management – a dose finding trial
IRAS ID
254750
Contact name
Catherine Carrington
Contact email
Sponsor organisation
Novo Nordisk Ltd
Eudract number
2018-001945-14
Duration of Study in the UK
1 years, 1 months, 10 days
Research summary
The prevalence of obesity is increasing; globally, more than 600 million people have obesity. People suffering from overweight or obesity are more likely to get diseases like type 2 diabetes and high blood pressure. Losing weight has been shown to lower the risk and impact of these diseases.
Being overweight or obese is most often treated with changes to food intake and physical activity; this does not result in a weight loss for all people. Completed studies show that a new medicine called NNC0174-0833 may help lower body weight. NNC0174-0833 is similar to the hormone amylin that is naturally made in your body. It acts like the body’s own hormone which helps the body to feel full.
This study will look mainly at change in body weight. Weight loss of people taking different doses of NNC0174-0833 will be compared to the weight loss of people taking liraglutide (a medicine that is already available) or placebo (a dummy medication).
If eligible, participants will be randomised to either once weekly doses of NNC0174-0833/NNC0174-0833placebo or once daily doses of ligarlutide/liraglutide placebo.All treatments will be administered by subcutaneous (under the skin) injection. The study is blinded – this means that neither the participant nor the study doctor will know whether the participant is taking active medication or placebo. In addition to the study medication, all trial participants will also receive diet and physical activity counselling.
Study duration is 33 weeks: a 1 week screening period, a 26 week treatment period and a 6 week follow-up period. The study consists of 12 clinic visits. The study plans to include 700 participants across 11 countries. In the UK the planned number of participants is 70 across 7 sites.
REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
18/EM/0364
Date of REC Opinion
18 Dec 2018
REC opinion
Further Information Favourable Opinion