← Back to Search

Melanocortin-4 Receptor Agonist

Setmelanotide for Obesity

Phase 3
Recruiting
Research Sponsored by Rhythm Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must have a homozygous, heterozygous, or compound heterozygous variant in the NCOA1 (SRC1)
Patients must have a pre-identified heterozygous genetic variant in the POMC gene or PCSK1 gene
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 52 weeks
Awards & highlights

Study Summary

This trialtests a drug to treat obesity in people with certain gene variants. Results will be compared to placebo.

Who is the study for?
This trial is for people aged 6-65 with obesity and specific genetic variants affecting the MC4R pathway. They should have tried diet and exercise, experienced childhood obesity, and not be pregnant or breastfeeding. Exclusions include recent bariatric surgery, severe psychiatric or medical conditions, a history of melanoma or certain skin lesions, significant weight loss recently, or participation in other drug trials within the last three months.Check my eligibility
What is being tested?
The EMANATE trial is testing Setmelanotide against a placebo to see if it helps with weight loss in patients who have certain gene variants linked to obesity. It's randomized (participants are put into groups by chance), double-blind (neither participants nor researchers know who gets what treatment), and has identical goals across different sub-studies focusing on various genes.See study design
What are the potential side effects?
While the side effects for Setmelanotide aren't detailed here, similar medications can cause reactions at injection sites, nausea, increased pigmentation of skin or hair areas previously affected by inflammation like scars or moles; fullness; headache; fatigue; elevated blood pressure; and hormonal changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My genetic test shows a variant in the NCOA1 gene.
Select...
I have a genetic variant in the POMC or PCSK1 gene.
Select...
I have a specific genetic change in the LEPR gene.
Select...
I am between 6 and 65 years old.
Select...
I have a genetic variation or deletion in the SH2B1 gene.
Select...
I have a history of excessive hunger.
Select...
I am considered obese based on my BMI.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 52 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 52 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Difference in mean change in body weight in patients treated with setmelanotide compared to placebo, assessed as percent change in BMI
Secondary outcome measures
The difference in mean change in body weight in adult patients treated with setmelanotide compared to placebo, assessed as percent change in baseline body weight
The difference in mean percent change in the weekly average most hunger score in patients treated with setmelanotide compared to placebo
The proportion of patients who achieve at least 10% reduction in BMI in patients treated with setmelanotide compared to placebo
+1 more

Trial Design

4Treatment groups
Experimental Treatment
Group I: SH2B1 variantExperimental Treatment2 Interventions
1:1 Randomization
Group II: POMC or PCSK1 variantExperimental Treatment2 Interventions
1:1 Randomization
Group III: NCOA1 (SRC1) variantExperimental Treatment2 Interventions
1:1 Randomization
Group IV: LEPR variantExperimental Treatment2 Interventions
1:1 Randomization
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Setmelanotide
FDA approved
Placebo
1995
Completed Phase 3
~2670

Find a Location

Who is running the clinical trial?

Rhythm Pharmaceuticals, Inc.Lead Sponsor
25 Previous Clinical Trials
8,903 Total Patients Enrolled
17 Trials studying Obesity
2,538 Patients Enrolled for Obesity
David Meeker, MDStudy ChairRhythm Pharmaceuticals, Inc.
13 Previous Clinical Trials
1,165 Total Patients Enrolled
9 Trials studying Obesity
895 Patients Enrolled for Obesity
Linda Shapiro, MD PhDStudy ChairRhythm Pharmaceuticals, Inc.

Media Library

Setmelanotide (Melanocortin-4 Receptor Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT05093634 — Phase 3
Obesity Research Study Groups: NCOA1 (SRC1) variant, POMC or PCSK1 variant, LEPR variant, SH2B1 variant
Obesity Clinical Trial 2023: Setmelanotide Highlights & Side Effects. Trial Name: NCT05093634 — Phase 3
Setmelanotide (Melanocortin-4 Receptor Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05093634 — Phase 3
Obesity Patient Testimony for trial: Trial Name: NCT05093634 — Phase 3

Frequently Asked Questions

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

Could you tell me the exact number of establishments engaged in this trial?

"As of now, this medical research is accepting participants from twelve different centres. Some cities that are included in the list are Houston, Suwanee and Dearborn along with nine other locales. To make sure your commute is as short as possible, consider joining a trial at the closest location to you."

Answered by AI

To what maladies is the POMC or PCSK1 variant usually prescribed?

"POMC or PCSK1 variant are both suitable treatments for chronic weight management therapy, obesity, and POMC deficiency obesity."

Answered by AI

Are investigators currently taking on new participants for this research?

"Information available on clinicaltrials.gov indicates that this medical trial is currently accepting applications; the initial posting was made on December 10th 2021, with the last update occuring on November 21st 2022."

Answered by AI

Has any research uncovered the implications of POMC or PCSK1 variation?

"In 2018, the Marshfield Clinic Research Institute first evaluated POMC and PCSK1 variants. Since then, 18339 trials have been completed in total - 4 of which are ongoing and conducted primarily from Houston, GA."

Answered by AI

Could you provide an estimate of the maximum amount of participants enrolled in this clinical trial?

"To adequately conduct the trial, Rhythm Pharmaceuticals, Inc. requires 400 participants who satisfy its inclusion criteria. Two medical centres have been identified to manage the study: Texas Children's Hospital in Houston and InQuest Medical Research in Suwanee, Michigan."

Answered by AI

Who would be an ideal candidate to join this clinical research program?

"This trial is recruiting 400 individuals between the ages of 6 and 65 who are currently living with obesity. Participants must also present a Heterozygous genetic variant in either the POMC or PCSK1 gene, Homozygous, heterozygous, or compound heterozygous variant in SH2B1 gene, 16p11.2 chromosomal deletion encompassing SH2B1 gene; BMI ≥30 kg/m² for those aged 18+ and ≥ 95th percentile for those under 17 years; have tried to treat their condition through diet and exercise before enrolling; agree to use highly effective contraception during the study period as"

Answered by AI

What potential risks and benefits come with utilizing a POMC or PCSK1 variant for individuals?

"The POMC or PCSK1 variant has been evaluated with a score of 3, as the Phase 3 trial it is part of provides ample evidence for both its efficacy and safety."

Answered by AI

Are participants below the age of 25 eligible to join this research trial?

"This clinical trial is seeking participants aged between 6 and 65. For those outside of this range, there are 206 trials for individuals below 18 years old and 599 studies available to patients above the age of 65."

Answered by AI

Is this endeavor a pioneering trial?

"Rhythm Pharmaceuticals, Inc. is behind the initial trial for POMC or PCSK1 variant from 2018, which has since progressed through both Phase 2 and 3 drug approval stages with 150 participants involved. Since then, 38 cities across 10 countries have seen 4 active studies involving a total of 18339 trials conducted in the past four years."

Answered by AI

Who else is applying?

What state do they live in?
Indiana
Tennessee
New Jersey
Other
What site did they apply to?
HonorHealth Bariatric Center
Endocrine Associates of Dallas and Plano
Children's Hospital Los Angeles
Other
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0
3+

What questions have other patients asked about this trial?

When can I start? Is screening in person or on the phone?
PatientReceived 1 prior treatment

Why did patients apply to this trial?

Im worried about my weight, my index is over 30. I am extremely desperate and looking for any help.
PatientReceived 2+ prior treatments
My doctor has office in Burbank , I am motivated because of my health will improve.
PatientReceived no prior treatments
I have tried everything over my life and nothing is working… pills, diets, therapy.
PatientReceived no prior treatments
~80 spots leftby Dec 2024