Study testing GIP & amylin treatments on gut-related side effects in overweight/obese participants
Research type
Research Study
Full title
A Single-Centre Study Investigating the Role of Long-Acting Subcutaneous Glucose-dependent Insulinotropic Polypeptide Receptor Agonist (GIP RA) in Combination with Long-Acting Subcutaneous Amylin Receptor Agonist on Gastrointestinal Tolerability in Participants with Overweight and Obesity
IRAS ID
1013020
Contact name
Sanaz Gabery
Contact email
Sponsor organisation
Novo Nordisk A/S
Research summary
This is a randomised, double-blinded, placebo-controlled trial at a single centre. 100 healthy female participants of 18 to 64 years will be included. The purpose of this trial is to find out if combining 2 trial medications, NNC0480-0389 and cagrilintide, can help reduce common stomach problems (like diarrhoea and feeling sick) that can occur after dosing with cagrilintide. In addition to safety and tolerability, the amount of trial medications in the body over time will be checked. The trial consists of a screening period of up to 28 days and 2 in-house stays (Treatment Periods [TPs]) of 17 days each. The TPs will be separated by a washout period of at least 8 weeks (with 6 additional visits). Dosing will be on Days 1, 2, 9 and 10 (TP 1) as well as Days 74, 75, 82 and 83 (TP 2). The trial medication will be given by injection under the skin. All participants will be followed up from Day 90 to 141 (with 6 visits) and have a last visit on Day 142. Participants will be divided into 4 groups. In all groups, participants will receive 1.7 mg cagrilintide on the 2nd day of each TP (Days 2 and 75) and 2.4 mg cagrilintide 8 days later (Days 10 and 83). In addition, the participants in 2 of the 4 groups will receive either (1 group) in the 1st period NNC0480-0389, 17 mg on Day 1 and 24 mg on Day 9, and in the 2nd period placebo (a dummy substance, on Days 74 and 82), or (other group) the other way round (placebo in the 1st period and NNC0480-0389 in the 2nd period). In the other 2 groups, participants will receive in addition either (1 group) in the 1st period NNC0480-0389, 42.5 mg on Day 1 and 60 mg on Day 9, and in the 2nd period placebo (on Days 74 and 82) or (other group) the other way round (placebo in the 1st period and NNC0480-0389 in the 2nd period).
Both trial medications are being developed by Novo Nordisk for the treatment of type 2 diabetes and weight management. So far, 3 studies have been completed with NNC0480-0389 and 11 studies with cagrilintide.REC name
London - Surrey Borders Research Ethics Committee
REC reference
25/LO/0729
Date of REC Opinion
19 Jan 2026
REC opinion
Further Information Favourable Opinion