In short
Clinical trials are studying Setmelanotide in people with obesity linked to specific genetic variants and in people with ROHHAD syndrome. These studies look at whether Setmelanotide can help with weight changes and other symptoms, and they measure safety and effectiveness in different patient groups.
Key points
- Clinical trials of Setmelanotide are studying two rare patient groups: people with obesity linked to specific genetic variants and people with ROHHAD syndrome. One study is Phase 3 and plans to enroll 385 participants, while the other is Phase 2 and plans to enroll 5 patients. The obesity study measures body weight change after 52 weeks compared with placebo. The ROHHAD study measures changes in signs and symptoms of hypothalamic dysfunction at 16, 32, and 52 weeks. Both trials are authorised and are focused on how well Setmelanotide may help in these specific conditions.
Clinical trial overview
These studies are interventional trials, which means researchers give a study treatment and then measure the results in people.
Both trials are listed as authorised, and both are designed to study Setmelanotide in specific patient groups.
Phase 3 study in obesity with specific genetic variants
The first trial, NCT05093634, is a Phase 3 study in patients with obesity linked to specific genetic variants.
The study title says it is for patients with obesity with specific genetic variants, and the condition description says it involves improper function of certain messenger materials in the body that control body weight and hunger in people.
This trial plans to enroll 385 participants.
The brief summary says the goal is to evaluate the efficacy of Setmelanotide on changes in body weight.
Phase 2 ROHHAD syndrome study
The second trial, 2024-516753-45-00, is a Phase 2 study called the ROH-SET study.
It is studying Setmelanotide in people with ROHHAD syndrome, a rare condition named in the trial data.
This study plans to enroll 5 patients.
The brief summary says the study aims to evaluate the effect of Setmelanotide on hypothalamic dysfunction in these patients after 16 weeks, 32 weeks, and 52 weeks.
What the trials measure
The Phase 3 obesity trial uses a primary outcome based on the difference in mean change in body weight from baseline at 52 weeks, compared with placebo.
The same outcome is also described as percent change from baseline body mass index (BMI), which is a number based on height and weight.
The ROHHAD study measures changes in overall scores for signs and symptoms of hypothalamic dysfunction at 16, 32, and 52 weeks.
Hypothalamic dysfunction means problems in the hypothalamus, a part of the brain that helps control hunger, weight, and other body functions.
Who these trials are for
These trials are not for general obesity or general illness; they focus on people with the specific conditions named in the trial records.
The first study is for patients with obesity and specific genetic variants, while the second is for patients with ROHHAD syndrome.
Together, the studies show that research on Setmelanotide is focused on rare or special patient groups where the main questions are whether the treatment can improve weight-related outcomes or symptoms linked to hypothalamic dysfunction.