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Melanocortin-4 Receptor Agonist

Setmelanotide for Obesity

Q: Has Setmelanotide been sanctioned by the Food and Drug Administration?

Our team at Power judged Setmelanotide's safety on a scale of 1 to 3, awarding it 2 points. This is because there are some studies affirming its security yet no data that proves the drug's effectiveness.

Q: Does this trial represent a breakthrough in its field?

Presently, 4 extant clinical trials for Setmelanotide are in progress across 38 cities and 10 nations. Rhythm Pharmaceuticals Inc's initial investigation into the drug was spearheaded in 2018 with a cohort of 150 participants; it completed its Phase 2 &#x26; 3 testing stage before being implemented more broadly. Since then, 18331 additional studies have been finalized.

Q: Are there any Canadian healthcare facilities currently administering this trial?

The current clinical trial is accepting participants at 21 healthcare centres, including Amarillo, Philadelphia and <a href="https://www.withpower.com/clinical-trials/new-york">New york</a>. To reduce travel requirements, it's recommended that you select the closest medical centre to your residence.

Q: How many participants are participating in this experiment?

Affirmative. Clinicaltrials.gov attests that this clinical trial is presently recruiting participants, which were first posted on November 30th 2021 and last edited on November 28th 2022. 150 patients need to be recruited across 21 sites for the study to move forward.

Q: Is it possible to participate in this experimental program?

Candidates between 6 and 65 years old that meet the criteria of <a href="https://www.withpower.com/clinical-trials/obesity">obesity</a> are eligible to participate in this medical research. The trial has a proposed enrollment goal of 150 participants.

Q: What are the main aims of this trial?

According to Rhythm Pharmaceuticals, Inc., the principal measurement of efficacy in this trial will be the proportion of patients with genetic variants in the MC4R pathway who experience a clinically relevant reduction in body weight over 16 weeks. Additionally, secondary outcomes include changes in mean maximal hunger scores and BMI for <a href="https://www.withpower.com/clinical-trials/all">all</a> enrollees as well as those aged 12 or older; moreover, there is an evaluation into how many participants achieve at least a two-point improvement on their weekly average daily maximal hunger score.

Q: Is this research endeavor open to individuals aged 45 or over?

This trial is restricted to individuals aged 6 and 65, with 207 trials specifically targeting younger patients while 598 studies are tailored for those over the age of retirement.

Q: Is this research initiative still taking new participants?

Per the information posted on clinicaltrials.gov, this study is actively recruiting trial participants. It was initially made public on November 30th 2021 and recently updated in late November 2022.

Q: Has Setmelanotide been evaluated in other research studies?

The first trials of setmelanotide were conducted in 2018 at Marshfield Clinic Research Institute. To date, 18331 studies have been finished and 4 new ones are actively recruiting participants mainly from Amarillo, <a href="https://www.withpower.com/clinical-trials/pennsylvania">Pennsylvania</a>.

Q: What therapeutic effects have been observed with Setmelanotide?

The hormone analog Setmelanotide is effective at treating chronic weight management therapy, <a href="https://www.withpower.com/clinical-trials/obesity">obesity</a>, and Pomc deficiency-related obesity.

Phase 2

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

Patients must have a pre-identified genetic variant in an established MC4R pathway gene that contributes to obesity

Age 6 to 65 years, inclusive

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to end of stage 1 (16 weeks)

Awards & highlights

Study Summary

This trial is testing whether setmelanotide can help people with obesity who have gene variants that affect the melanocortin-4 receptor pathway.

Who is the study for?

This trial is for people aged 6-65 with severe obesity linked to specific genetic changes in the MC4R pathway. Participants must understand the study, use effective birth control, and have a BMI ≥40 kg/m2 (adults) or ≥97th percentile for their age/gender (children). Excluded are those with certain other genetic conditions, recent bariatric surgery, significant health issues like liver disease or melanoma risk, psychiatric disorders, or recent weight loss treatments.Check my eligibility

What is being tested?

The DAYBREAK study tests Setmelanotide's effectiveness on obesity due to MC4R pathway gene variants. It starts with an open-label phase where everyone gets Setmelanotide followed by a blind phase where participants randomly receive either Setmelanotide or a placebo without knowing which one they're getting.See study design

What are the potential side effects?

While not specified here, potential side effects of Setmelanotide may include reactions at the injection site, increased pigmentation of skin or hair, nausea and possibly others based on its action in regulating appetite and energy expenditure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have a genetic variant linked to obesity.

Select...

I am between 6 and 65 years old.

Select...

I often feel an uncontrollable urge to eat.

Select...

I am considered obese based on my BMI.

Select...

I (or my guardian) understand the study and can consent.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to end of stage 1 (16 weeks)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to end of stage 1 (16 weeks)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to end of stage 1 (16 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

The proportion of patients by genotype who achieve MC4R pathway who achieve a ≥5% reduction in BMI

Secondary outcome measures

Mean change and percent change in BMI in all patients and patients ≥18 years old, per gene

Mean change and percent change in body weight in patients ≥18 years old, per gene

Mean change in BMI Z-score in patients <18 years old, per gene

+2 more

Side effects data

From 2020 Phase 3 trial • 15 Patients • NCT03287960

73%

Injection site erythema

73%

Skin hyperpigmentation

53%

Injection site pruritus

53%

Nausea

47%

Injection site induration

47%

Injection site pain

47%

Diarrhea

40%

Injection site oedema

33%

Injection site bruising

33%

Headache

27%

Nasopharyngitis

27%

Dizziness

27%

Back pain

27%

Asthenia

27%

Insomnia

27%

Spontaneous penile erection

27%

Abdominal pain upper

27%

Arthralgia

20%

Injection site hypersensitivity

20%

Influenza like illness

20%

Anxiety

20%

Anemia

20%

Muscle spasms

13%

Rhinitis

13%

Melanocytic naevus

13%

Malaise

13%

Gastrointestinal infection

13%

Hypothyroidism

13%

Injection site haematoma

13%

Pharyngitis

13%

Fatigue

13%

Depression

13%

Depressed mood

13%

Constipation

13%

Vomiting

13%

Erythema

13%

Hyperhidrosis

Torticollis

Eye naevus

Chest pain

Decreased appetite

Lentigo

Bronchitis

Lipodystrophy acquired

Folate deficiency

Affect lability

Fungal infection

Pigmentation disorder

Glucose tolerance impaired

Drug abuse

Cholecystitis

Ear pain

Hypogonadism

Otitis externa

Urticaria

Gout

Sciatica

Hair growth rate abnormal

Rash

Influenza

Migraine

Dyslipidaemia

Presyncope

Hyperkeratosis

Sleep paralysis

Tic

Pain in extremity

Arthritis viral

Gastric Banding Reversal

Syncope

Tinnitus

Lower respiratory tract infection

Pruritus

Gastroenteritis

Pain of skin

Blood uric acid increased

Fear of injection

Road Traffic Accident

Suicidal Ideation

Flushing

Injection site atrophy

Injection site reaction

Injection site urticaria

Medical device pain

Medical device site erythema

Oedema

Pyrexia

Xerosis

Suicidal ideation

Illusion

Dysmenorrhoea

Ejaculation disorder

Metrorrhagia

Amenorrhoea

Ovarian cyst

Vaginal haemorrhage

Arthropod bite

Foot fracture

Joint Injury

Ligament sprain

Alanine aminotransferase increased

Blood creatine phosphokinase abnormal

Blood follicle stimulating hormone increased

Blood lactate dehydrogenase increased

Blood luteinising hormone increased

Blood urea decreased

Heart rate increased

Insulin tolerance test abnormal

Neutrophil count increased

Weight increased

Cardiac flutter

Oropharyngeal pain

Asthma

Eosinophilia

Iron deficiency anemia

Vertigo

Abdominal pain

Gingival discolouration

Abdominal discomfort

Abdominal distension

Dyspepsia

Gastrooesophageal reflux disease

Haemorrhoids

Cholestasis

Hepatocellular injury

Haematuria

Proteinuria

Renal colic

Renal failure

Skin striae

Vitamin A deficiency

Injection site abscess

Musculoskeletal pain

Musculoskeletal chest pain

Neck pain

100%

80%

60%

40%

20%

Study treatment Arm

Setmelanotide

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: SetmelanotideExperimental Treatment1 Intervention

Patients with specific gene variants in the MC4R pathway on setmelanotide

Group II: PlaceboPlacebo Group1 Intervention

Patients with specific gene variants in the MC4R pathway on placebo

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Setmelanotide

2017

Completed Phase 4

~650

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Rhythm Pharmaceuticals, Inc.Lead Sponsor

25 Previous Clinical Trials

9,153 Total Patients Enrolled

17 Trials studying Obesity

2,788 Patients Enrolled for Obesity

David Meeker, MDStudy ChairRhythm Pharmaceuticals, Inc.

13 Previous Clinical Trials

1,415 Total Patients Enrolled

9 Trials studying Obesity

1,145 Patients Enrolled for Obesity

Murray Stewart, BM/DMStudy ChairRhythm Pharmaceuticals, Inc.

5 Previous Clinical Trials

338 Total Patients Enrolled

4 Trials studying Obesity

261 Patients Enrolled for Obesity

Media Library

Setmelanotide (Melanocortin-4 Receptor Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT04963231 — Phase 2

Obesity Research Study Groups: Setmelanotide, Placebo

Obesity Clinical Trial 2023: Setmelanotide Highlights & Side Effects. Trial Name: NCT04963231 — Phase 2

Setmelanotide (Melanocortin-4 Receptor Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04963231 — Phase 2

Obesity Patient Testimony for trial: Trial Name: NCT04963231 — Phase 2

Frequently Asked Questions

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

Has Setmelanotide been sanctioned by the Food and Drug Administration?

"Our team at Power judged Setmelanotide's safety on a scale of 1 to 3, awarding it 2 points. This is because there are some studies affirming its security yet no data that proves the drug's effectiveness."

Answered by AI

Does this trial represent a breakthrough in its field?

"Presently, 4 extant clinical trials for Setmelanotide are in progress across 38 cities and 10 nations. Rhythm Pharmaceuticals Inc's initial investigation into the drug was spearheaded in 2018 with a cohort of 150 participants; it completed its Phase 2 & 3 testing stage before being implemented more broadly. Since then, 18331 additional studies have been finalized."

Answered by AI

Are there any Canadian healthcare facilities currently administering this trial?

"The current clinical trial is accepting participants at 21 healthcare centres, including Amarillo, Philadelphia and New york. To reduce travel requirements, it's recommended that you select the closest medical centre to your residence."

Answered by AI

How many participants are participating in this experiment?

"Affirmative. Clinicaltrials.gov attests that this clinical trial is presently recruiting participants, which were first posted on November 30th 2021 and last edited on November 28th 2022. 150 patients need to be recruited across 21 sites for the study to move forward."

Answered by AI

Is it possible to participate in this experimental program?

"Candidates between 6 and 65 years old that meet the criteria of obesity are eligible to participate in this medical research. The trial has a proposed enrollment goal of 150 participants."

Answered by AI

What are the main aims of this trial?

"According to Rhythm Pharmaceuticals, Inc., the principal measurement of efficacy in this trial will be the proportion of patients with genetic variants in the MC4R pathway who experience a clinically relevant reduction in body weight over 16 weeks. Additionally, secondary outcomes include changes in mean maximal hunger scores and BMI for all enrollees as well as those aged 12 or older; moreover, there is an evaluation into how many participants achieve at least a two-point improvement on their weekly average daily maximal hunger score."

Answered by AI

Is this research endeavor open to individuals aged 45 or over?

"This trial is restricted to individuals aged 6 and 65, with 207 trials specifically targeting younger patients while 598 studies are tailored for those over the age of retirement."

Answered by AI

Is this research initiative still taking new participants?

"Per the information posted on clinicaltrials.gov, this study is actively recruiting trial participants. It was initially made public on November 30th 2021 and recently updated in late November 2022."

Answered by AI

Has Setmelanotide been evaluated in other research studies?

"The first trials of setmelanotide were conducted in 2018 at Marshfield Clinic Research Institute. To date, 18331 studies have been finished and 4 new ones are actively recruiting participants mainly from Amarillo, Pennsylvania."

Answered by AI

What therapeutic effects have been observed with Setmelanotide?

"The hormone analog Setmelanotide is effective at treating chronic weight management therapy, obesity, and Pomc deficiency-related obesity."

Answered by AI

Who else is applying?

What state do they live in?

Alabama

New Jersey

Other

Texas

How old are they?

18 - 65

What portion of applicants met pre-screening criteria?

Met criteria

Did not meet criteria

What site did they apply to?

University of Michigan

HonorHealth Bariatric Center

Endocrine Associates of Dallas and Plano

Other

How many prior treatments have patients received?

Why did patients apply to this trial?

Hoping to help and also loose weight and control my eating. I have never tried any medicine for weight loss but after emergency perforated diverticulitis surgery I have gained in excess of 30 lbs.

PatientReceived 2+ prior treatments

I am considered obese and have attempted many avenues to lose the weight unsuccessfully. I'm getting older now and it proves more difficult each day to function properly. I would truly appreciate an opportunity to try something new and advocate in the future.

PatientReceived 2+ prior treatments

I have been obese for 6 years. I look like my paternal grandmother, her siblings, and her mother. The same build and the same challenges with weight all my life since the age of 10. Starting 6 years I finally became obese. One knee has been replaced and I fear other joints will follow.

PatientReceived 2+ prior treatments