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Melanocortin 4 Receptor (MC4R) Agonist

Setmelanotide for Hypothalamic Obesity

Q: 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.

Q: 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.

Q: 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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline to week 60

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 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: 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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Rhythm Pharmaceuticals, Inc.Lead Sponsor

25 Previous Clinical Trials

9,183 Total Patients Enrolled

2 Trials studying Hypothalamic Obesity

108 Patients Enrolled for Hypothalamic Obesity

David Meeker, MDStudy ChairRhythm Pharmaceuticals, Inc.

13 Previous Clinical Trials

1,445 Total Patients Enrolled

1 Trials studying Hypothalamic Obesity

18 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

Lynn Health Science Institute

Seattle Children's Hospital, Research and Foundation - Center for Integrative Brain Research

Other

What portion of applicants met pre-screening criteria?

Did not meet criteria

Met criteria

How many prior treatments have patients received?

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

We are motivated to join the trial because we want our daughter Emily to be at a healthier weight and not worry so much about food and her next meal. We also want to help with research for other children/adults like her.

PatientReceived 2+ 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

Most responsive sites:

University of Florida: < 48 hours
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

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Setmelanotide for Hypothalamic Obesity

Study Summary

Timeline

Treatment Details

Study Objectives

Side effects data

Trial Design

Find a Location

Who is running the clinical trial?

Media Library

Frequently Asked Questions

What risks does a patient incur when taking Setemelanotide?

How many individuals are enrolled in this trial currently?

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

Who else is applying?

What state do they live in?

What site did they apply to?

What portion of applicants met pre-screening criteria?

How many prior treatments have patients received?

Why did patients apply to this trial?

What questions have other patients asked about this trial?

How responsive is this trial?

Average response time

Typically responds via

Most responsive sites:

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