RM-Acquired Hypothalamic Obesity
Research type
Research Study
Full title
A Phase 3, Double Blind, Randomized, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Setmelanotide in Patients with Acquired Hypothalamic Obesity.
IRAS ID
1007703
Contact name
Jennifer Crowley-Bartoshevich
Contact email
Sponsor organisation
Rhythm Pharmaceuticals, Inc.
Eudract number
2022-503116-16
Research summary
The purpose of this study is to evaluate safety and efficacy of setmelanotide for weight loss and changes in hunger, in patients from 4 years who have acquired hypothalamic obesity. Hypothalamic obesity caused by an injury to the hypothalamus. The hypothalamus is responsible for helping to control weight and hunger. Injury to the hypothalamus interferes with hormones that signal the brain to make one feel hungry or full. This injury typically occurs from a tumor, brain surgery, and/or trauma. In some people this injury can result in uncontrolled weight gain. Setmelanotide mimics the natural hormones that help control body weight and appetite; the study sponsor seeks to determine if setmelanotide helps control body weight and appetite in people with this condition. In this study, patients will be randomly assigned to receive the study medication or placebo. For every 2 patients who receive setmelanotide, 1 patient will receive a placebo. Setmelanotide is approved in the USA, Europe, Great Britain and Israel to treat people 6 years and older for genetic forms of obesity, and is available under the name IMCIVREE®. It is being used in this study in an experimental way for patients with acquired hypothalamic obesity. Setmelanotide will be given once a day by injection under the skin. Study patients will be taught how to administer the injection to themselves, so they can take the daily injections at home. The duration for participation is 68 weeks, with 8-week screening period and a 60-week treatment period.
1. Screening Period: patient will sign consent when all inclusion and exclusion criteria are confirmed
2. Treatment Period: patients will receive the study drug, attend study visits, or remote telehealth or home visits, complete questionnaires and have samples taken to assess study medication tolerance.
3. End of Study: patients will complete final questionnaires, provide final blood and urine samples, and return any used and unused study medication vials.REC name
London - West London & GTAC Research Ethics Committee
REC reference
23/LO/0350
Date of REC Opinion
5 Sep 2023
REC opinion
Further Information Favourable Opinion