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Setmelanotide

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.

Table of Contents

Clinical trial overview

These studies are interventional trials, which means researchers give a study treatment and then measure the results in people.[1][2]

Both trials are listed as authorised, and both are designed to study Setmelanotide in specific patient groups.[1][2]

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.[1]

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.[1]

This trial plans to enroll 385 participants.[1]

The brief summary says the goal is to evaluate the efficacy of Setmelanotide on changes in body weight.[1]

Phase 2 ROHHAD syndrome study

The second trial, 2024-516753-45-00, is a Phase 2 study called the ROH-SET study.[2]

It is studying Setmelanotide in people with ROHHAD syndrome, a rare condition named in the trial data.[2]

This study plans to enroll 5 patients.[2]

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.[2]

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.[1]

The same outcome is also described as percent change from baseline body mass index (BMI), which is a number based on height and weight.[1]

The ROHHAD study measures changes in overall scores for signs and symptoms of hypothalamic dysfunction at 16, 32, and 52 weeks.[2]

Hypothalamic dysfunction means problems in the hypothalamus, a part of the brain that helps control hunger, weight, and other body functions.[2]

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.[1][2]

The first study is for patients with obesity and specific genetic variants, while the second is for patients with ROHHAD syndrome.[1][2]

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.[1][2]

Trial ID Phase Condition studied Status Enrollment Main endpoint
NCT05093634 Phase 3 Obesity with specific genetic variants Authorised 385 Mean change in body weight at 52 weeks, measured as percent change from baseline BMI
2024-516753-45-00 Phase 2 ROHHAD syndrome Authorised 5 Change in overall signs and symptoms of hypothalamic dysfunction at 16, 32, and 52 weeks

FAQ

  • What are the Setmelanotide clinical trials studying? They are studying whether Setmelanotide can help people with obesity linked to specific genetic variants and people with ROHHAD syndrome. The trials focus on changes in body weight and signs of hypothalamic dysfunction, which means problems in a brain area that helps control many body functions.
  • Who can take part in these trials? One trial includes patients with obesity and specific genetic variants. The other trial includes 5 patients with ROHHAD syndrome. Each study has its own entry rules based on the condition being studied.
  • What phases are the Setmelanotide trials in? One study is Phase 3 and the other is Phase 2. Phase 2 studies usually look more closely at early signs of benefit, while Phase 3 studies compare treatment effects in a larger group.
  • What outcomes are being measured? The obesity trial measures the change in body weight at 52 weeks, compared with placebo, using percent change from baseline body mass index. The ROHHAD study measures changes in overall signs and symptoms of hypothalamic dysfunction at 16, 32, and 52 weeks.
  • How many people are planned for these trials? The Phase 3 obesity study plans to enroll 385 participants. The ROHHAD syndrome study plans to enroll 5 patients.

Ongoing Clinical Trials on Setmelanotide

  • Study on Setmelanotide for Improving Hypothalamic Function in Patients with ROHHAD Syndrome

    Recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    The Netherlands

  • Study of Setmelanotide for Patients with Obesity Due to Specific Genetic Variants

    Not recruiting

    3 1 1
    Investigated diseases:
    Investigated drugs:
    France Germany Greece The Netherlands Spain

Glossary

  • Clinical trial: A research study in people that tests whether a treatment is safe and works for a certain condition.
  • Interventional study: A trial where researchers give a treatment and then measure what happens.
  • Phase 2: An earlier trial phase that looks at whether a treatment may help and continues to gather safety information.
  • Phase 3: A later trial phase with more participants, used to compare a treatment with placebo or another treatment.
  • Placebo: A look-alike treatment with no active study drug, used for comparison.
  • Enrollment: The number of people planned to join a study.
  • Body mass index (BMI): A number based on height and weight that helps estimate body size.
  • Baseline: The starting point before the study treatment begins.
  • Primary outcome: The main result researchers measure to see if the treatment works.
  • Hypothalamic dysfunction: Problems in the hypothalamus, a part of the brain that helps control hunger, weight, and other body functions.
  • ROHHAD syndrome: A rare syndrome studied in one trial; the trial measures signs and symptoms linked to hypothalamic dysfunction.

References