← Back to Search

Melanocortin 4 Receptor (MC4R) Agonist

Setmelanotide for Hypothalamic Obesity

Phase 3
Waitlist Available
Research Sponsored by Rhythm Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline to week 60
Awards & highlights

Study Summary

This trial will test if an injection can reduce weight & hunger in children & adults with acquired Hypothalamic Obesity. Participants take daily injections & complete assessments up to 60 weeks to see if it works & is safe.

Who is the study for?
This trial is for people aged 4 and older with acquired Hypothalamic Obesity, marked by weight gain after hypothalamic injury. Adults must have a BMI of ≥30 kg/m2, while children need a BMI in the top 95th percentile. Participants should agree to use effective contraception during and post-trial.Check my eligibility
What is being tested?
The study tests Setmelanotide's effectiveness on weight reduction, hunger control, and life quality in HO patients compared to placebo. It involves daily injections and assessments over up to 60 weeks.See study design
What are the potential side effects?
Potential side effects are not explicitly listed but may include reactions at the injection site, general discomfort or changes related to hormone activity due to Setmelanotide's role as an appetite regulator.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline to week 60
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to week 60 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Mean % change in BMI
Secondary outcome measures
Mean BMI-z score and BMI percentile reduction in patients <18 (using combined height and weight to report BMI in kg/m2)
Mean change in Symptoms of Hyperphagia total score
Mean change in physical functioning score and total score for the Impact of Weight on Quality of Life-Lite (IWQOL)
+8 more

Side effects data

From 2022 Phase 4 trial • 77 Patients • NCT05046132
46%
Nausea
39%
Injection site pain
29%
Vomiting
25%
Injection site erythema
21%
Ephelides
21%
Decreased appetite
18%
Skin hyperpigmentation
14%
Injection site swelling
14%
Headache
14%
Erection increased
11%
Fatigue
11%
Injection site pruritus
7%
Abdominal pain
7%
Constipation
4%
Hepatitis acute
4%
Asthenia
4%
Chills
4%
Medical device site dermatitis
4%
Aphthous ulcer
4%
Change of bowel habit
4%
Gingival discolouration
4%
Pruritus
4%
Cough
4%
Dyspnoea
4%
Rhinorrhoea
4%
Pain in extremity
4%
Blood creatine phosphokinase increased
4%
Pancreatitis acute
4%
Injection site induration
4%
Chapped lips
4%
Hyperaesthesia teeth
4%
Diarrhoea
4%
Rash
4%
Dry throat
4%
Muscle spasms
4%
Skin abrasion
4%
Palpitations
4%
Abnormal dreams
100%
80%
60%
40%
20%
0%
Study treatment Arm
Group 1: Setmelanotide 2 mg
Group 1: Setmelanotide 3 mg
Group 1: Setmelanotide 7 mg
Group 1: Setmelanotide 5 mg
Group 2: Placebo
Group 2: Moxifloxacin 400mg
Group 3: Moxifloxacin 400mg
Group 3: Placebo

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: SetemelanotideExperimental Treatment1 Intervention
Randomized 2:1 (Setmelanotide: Placebo)
Group II: PlaceboPlacebo Group1 Intervention
Randomized 2:1 (Setmelanotide: Placebo)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Setmelanotide
2017
Completed Phase 4
~650

Find a Location

Who is running the clinical trial?

Rhythm Pharmaceuticals, Inc.Lead Sponsor
26 Previous Clinical Trials
9,211 Total Patients Enrolled
3 Trials studying Hypothalamic Obesity
136 Patients Enrolled for Hypothalamic Obesity
David Meeker, MDStudy ChairRhythm Pharmaceuticals, Inc.
14 Previous Clinical Trials
1,473 Total Patients Enrolled
2 Trials studying Hypothalamic Obesity
46 Patients Enrolled for Hypothalamic Obesity

Media Library

Hypothalamic Obesity Clinical Trial 2023: Setmelanotide Highlights & Side Effects. Trial Name: NCT05774756 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What risks does a patient incur when taking Setemelanotide?

"Our team at Power gives setemelanotide a safety rating of 3, as it is currently undergoing Phase 3 trials and there are sufficient indications that the drug has efficacy and poses no major risk."

Answered by AI

How many individuals are enrolled in this trial currently?

"Absolutely. According to clinicaltrials.gov, the trial that was initially posted on March 26th 2023 is presently seeking patients; it was most recently updated on 16th of March in the same year. The protocol envisages recruiting 120 participants from a single medical facility."

Answered by AI

Is there availability for individuals to actively participate in this experiment?

"Affirmative. Clinicaltrials.gov confirms that this medical research is currently accepting participants, after first being posted on March 26th 2023 and recently updated on the 16th of March in the same year. There are 120 positions available at a single location."

Answered by AI

Who else is applying?

What state do they live in?
California
Alberta
Washington
Other
What site did they apply to?
Children's Minnesota
Seattle Children's Hospital, Research and Foundation - Center for Integrative Brain Research
Lynn Health Science Institute
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
3+
0
2
1

Why did patients apply to this trial?

Nothing works to lose weight I just keep gaining. I(Jocelyn) have spoken with Dr Miller previously regarding my daughter Emily.
PatientReceived 2+ prior treatments
Have struggled with life altering hypothalamic obesity for the last 10 years (after my craniotomy in 2013).
PatientReceived no prior treatments

What questions have other patients asked about this trial?

When does it start? How soon should we expect to hear back from someone regarding beginning the qualification process?
PatientReceived 2+ prior treatments
How long are the visits, would I have any say in date/time? Are there any over night stays? Are there any costs to me?
PatientReceived 1 prior treatment
This trial has been going awhile. Are you still recruiting and if so how quick is the process of being possibly accepted?
PatientReceived 2+ prior treatments
How often do you have to go into the clinic? From what I understand, it is daily injections…is this correct? How long is the study? If we were to receive the placebo, would we be eligible for the drug at the end of the trial and for how long?
PatientReceived 1 prior treatment

How responsive is this trial?

Average response time
  • < 2 Days
Typically responds via
Email
Most responsive sites:
  1. University of Florida: < 48 hours
  2. Children's Minnesota: < 48 hours
Recent research and studies
clinicaltrials.govStudy
A Trial of Setmelanotide in Acquired Hypothalamic Obesity
2023. "A Trial of Setmelanotide in Acquired Hypothalamic Obesity". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05774756.
All > Raymond A Wood
~57 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top