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Melanocortin 4 Receptor (MC4R) Agonist

Long-Term Setmelanotide for Obesity

Phase 2 & 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
Patients aged 2 or older who have completed participation in a previous setmelanotide trial and demonstrated adequate safety and meaningful clinical benefit (efficacy)
Timeline
Screening 8 weeks
Treatment 52 weeks
Follow Up 3 days
Awards & highlights

Study Summary

This trial is to study the safety and tolerability of setmelanotide, a drug used to treat obesity, in patients who have completed a previous trial on the same drug.

Who is the study for?
This trial is for patients aged 2 or older who have previously been treated with setmelanotide for obesity linked to genetic defects and saw benefits. They must be able to follow the study plan, use effective birth control, and not have significant liver disease, severe kidney issues, certain psychiatric disorders, a history of melanoma or suicidal behavior.Check my eligibility
What is being tested?
The trial is testing the long-term safety and effectiveness of continued setmelanotide treatment in those who've shown positive results from earlier trials. Setmelanotide targets specific genetic causes of obesity by acting on a pathway that controls weight.See study design
What are the potential side effects?
While not explicitly listed here, potential side effects may include reactions at the injection site, increased skin pigmentation, nausea or vomiting due to its action on pathways involved in appetite regulation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am over 2 years old and have safely benefited from a prior setmelanotide trial.

Timeline

Screening ~ 8 weeks
Treatment ~ 52 weeks
Follow Up ~3 days
This trial's timeline: 8 weeks for screening, 52 weeks for treatment, and 3 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Safety and tolerability of setmelanotide
Secondary outcome measures
Assessment of Health Status
Assessment of Quality of Life
Biomarker Assays
+6 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
7%
Torticollis
7%
Eye naevus
7%
Chest pain
7%
Decreased appetite
7%
Lentigo
7%
Bronchitis
7%
Lipodystrophy acquired
7%
Folate deficiency
7%
Affect lability
7%
Fungal infection
7%
Pigmentation disorder
7%
Glucose tolerance impaired
7%
Drug abuse
7%
Cholecystitis
7%
Ear pain
7%
Hypogonadism
7%
Otitis externa
7%
Urticaria
7%
Gout
7%
Sciatica
7%
Hair growth rate abnormal
7%
Rash
7%
Influenza
7%
Migraine
7%
Dyslipidaemia
7%
Presyncope
7%
Hyperkeratosis
7%
Sleep paralysis
7%
Tic
7%
Pain in extremity
7%
Arthritis viral
7%
Gastric Banding Reversal
7%
Syncope
7%
Tinnitus
7%
Lower respiratory tract infection
7%
Pruritus
7%
Gastroenteritis
7%
Pain of skin
7%
Blood uric acid increased
7%
Fear of injection
7%
Road Traffic Accident
7%
Suicidal Ideation
7%
Flushing
7%
Injection site atrophy
7%
Injection site reaction
7%
Injection site urticaria
7%
Medical device pain
7%
Medical device site erythema
7%
Oedema
7%
Pyrexia
7%
Xerosis
7%
Suicidal ideation
7%
Illusion
7%
Dysmenorrhoea
7%
Ejaculation disorder
7%
Metrorrhagia
7%
Amenorrhoea
7%
Ovarian cyst
7%
Vaginal haemorrhage
7%
Arthropod bite
7%
Foot fracture
7%
Joint Injury
7%
Ligament sprain
7%
Alanine aminotransferase increased
7%
Blood creatine phosphokinase abnormal
7%
Blood follicle stimulating hormone increased
7%
Blood lactate dehydrogenase increased
7%
Blood luteinising hormone increased
7%
Blood urea decreased
7%
Heart rate increased
7%
Insulin tolerance test abnormal
7%
Neutrophil count increased
7%
Weight increased
7%
Cardiac flutter
7%
Oropharyngeal pain
7%
Asthma
7%
Eosinophilia
7%
Iron deficiency anemia
7%
Vertigo
7%
Abdominal pain
7%
Gingival discolouration
7%
Abdominal discomfort
7%
Abdominal distension
7%
Dyspepsia
7%
Gastrooesophageal reflux disease
7%
Haemorrhoids
7%
Cholestasis
7%
Hepatocellular injury
7%
Haematuria
7%
Proteinuria
7%
Renal colic
7%
Renal failure
7%
Skin striae
7%
Vitamin A deficiency
7%
Injection site abscess
7%
Musculoskeletal pain
7%
Musculoskeletal chest pain
7%
Neck pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Setmelanotide

Trial Design

1Treatment groups
Experimental Treatment
Group I: SetmelanotideExperimental Treatment1 Intervention
Once daily subcutaneous injection
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Setmelanotide
FDA approved

Find a Location

Who is running the clinical trial?

Rhythm Pharmaceuticals, Inc.Lead Sponsor
25 Previous Clinical Trials
9,003 Total Patients Enrolled
17 Trials studying Obesity
2,638 Patients Enrolled for Obesity
Murray Stewart, MDStudy ChairRhythm Pharmaceuticals, Inc.
2 Previous Clinical Trials
60 Total Patients Enrolled
2 Trials studying Obesity
60 Patients Enrolled for Obesity
David Meeker, MDStudy ChairRhythm Pharmaceuticals, Inc.
13 Previous Clinical Trials
1,265 Total Patients Enrolled
9 Trials studying Obesity
995 Patients Enrolled for Obesity

Media Library

Setmelanotide (Melanocortin 4 Receptor (MC4R) Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT03651765 — Phase 2 & 3
Obesity Research Study Groups: Setmelanotide
Obesity Clinical Trial 2023: Setmelanotide Highlights & Side Effects. Trial Name: NCT03651765 — Phase 2 & 3
Setmelanotide (Melanocortin 4 Receptor (MC4R) Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03651765 — Phase 2 & 3
Obesity Patient Testimony for trial: Trial Name: NCT03651765 — Phase 2 & 3

Frequently Asked Questions

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

How is Setmelanotide most often employed?

"Setmelanotide is an effective chronic weight management therapy for patients with obesity, especially those with POMC deficiency obesity."

Answered by AI

Are there other ongoing Setmelanotide studies that you are aware of?

"The drug setmelanotide was first studied at the Marshfield Clinic Research Institute in 2018. There have been a total of 12 completed clinical trials since then, with 4 more currently ongoing. A large number of these live trials are based out of Nashville, Tennessee."

Answered by AI

To your knowledge, is this research unique in comparison to other similar investigations?

"There have been a total of 4 studies completed for Setmelanotide as of now. They were conducted in 31 cities across 9 different countries, with the first study taking place in 2018. The initial trial was sponsored by Rhythm Pharmaceuticals, Inc. and involved 150 patients. It successfully completed its Phase 2 & 3 drug approval stages. Since then, an additional 12 trials have been carried out."

Answered by AI

Are new patients currently being taken in for this experiment?

"The clinical trial is currently recruiting patients, as denoted by information available on clinicaltrials.gov. This research was originally posted on July 15th, 2018 with the most recent update occurring November 9th, 2022."

Answered by AI

How many places are responsible for this clinical trial's organization?

"As of now, 20 patients have been enrolled in the trial with locations including Vanderbilt University Medical Center in Nashville, Honor Health Research Institute in Scottsdale, Obesity Institute at Geisinger Clinic in Danville, and other centres."

Answered by AI

How many total patients are being surveyed in this investigation?

"That is correct. The clinical trial, which began recruitment on July 15th 2018, is still seeking 150 participants from 20 different sites, according to the latest information available on clinicaltrials.gov."

Answered by AI

Who else is applying?

What state do they live in?
North Carolina
New York
Other
Texas
How old are they?
65+
18 - 65
What site did they apply to?
Honor Health Research Institute
Synexus Clinical Research US, Inc. - Phoenix Southeast
Baylor College of Medicine
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
2
3+
1
0

Why did patients apply to this trial?

Help with obesity. Due to my obesity. Would like to be in a study to lose weight.
PatientReceived 1 prior treatment
Tried other drugs with no success hoping for help. I hope that this medication helped me lose weight.
PatientReceived no prior treatments

What questions have other patients asked about this trial?

Is this double blind study? How long does this trial last? When does it start? What is entailed?
PatientReceived 1 prior treatment
Is this compensation or non compensation?
PatientReceived no prior treatments

How responsive is this trial?

Typically responds via
Email
Phone Call
Most responsive sites:
  1. University at Buffalo: < 48 hours
  2. Baylor College of Medicine: < 48 hours
Average response time
  • < 2 Days
~28 spots leftby Dec 2024