Rhythm Pharmaceuticals

Rhythm Pharmaceuticals works on 3 rare diseases tracked on Trial Friend, including Addison Disease, Prader-Willi Syndrome, Stargardt Disease, with 6 recruiting clinical trials and 1 FDA-approved rare disease drug.

Rhythm Pharmaceuticals develops precision medicines targeting the MC4R pathway for rare genetic and hypothalamic obesity. IMCIVREE (setmelanotide) is FDA-approved for obesity caused by POMC, PCSK1, or LEPR deficiency, for Bardet-Biedl syndrome, and for acquired hypothalamic obesity (March 2026 expansion). Prader-Willi syndrome is in Phase 2 clinical development.

Type
Rare Disease Specialist
Ticker
RYTM
Headquarters
Boston, United States
Founded
2008
6
Active Rare Disease Trials
1
Approved Rare Disease Drugs
3
Rare Diseases in Portfolio
18
Years Active

Focus areas at Rhythm Pharmaceuticals

As a rare disease specialist, Rhythm Pharmaceuticals has active clinical trial programs and drug development efforts across 3 rare diseases, including Addison Disease, Prader-Willi Syndrome, Stargardt Disease. These programs may span orphan drug designation, novel therapeutic mechanisms, and precision medicine approaches targeting the underlying causes of each disease.

The clinical trials section below shows all active and recruiting studies sponsored by Rhythm Pharmaceuticals, sourced live from ClinicalTrials.gov. Each trial includes its current recruitment status, study phase (Phase 1 through Phase 4), conditions under investigation, and the number of active trial sites. The FDA-approved drugs section lists treatments that have received U.S. Food and Drug Administration approval, with brand names, generic names, approval dates, and matched rare disease indications from the openFDA database.

Rhythm Pharmaceuticals is headquartered in Boston, United States, founded in 2008, publicly traded under the ticker symbol RYTM. The company dedicates its research and development resources exclusively to rare and orphan diseases, working to bring innovative treatments to patients with conditions that have historically had limited or no treatment options.

Rhythm Pharmaceuticals Drug Pipeline

Rhythm Pharmaceuticals has 6 active clinical trials across 4 development stages, with 6 currently recruiting participants. Clinical trials advance through phases: Phase 1 tests safety in a small group, Phase 2 evaluates effectiveness and side effects, Phase 3 confirms benefit in a larger population, and Phase 4 monitors long-term safety after FDA approval.

Note: This pipeline includes all of Rhythm Pharmaceuticals's active interventional trials, not only those targeting rare diseases. We show the full pipeline because a company's broader research activity, therapeutic expertise, and development infrastructure directly shape its ability to advance rare disease programs. A strong overall pipeline often signals deeper clinical operations, faster enrollment capabilities, and greater commitment to bringing new treatments to patients.

Understand Rhythm Pharmaceuticals's pipeline
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2
Phase 22 trials
Recruiting
Hypothalamic Obesity+2 more
Recruiting
2
Phase 32 trials
Hypothalamic Obesity
Recruiting
Hypothalamic Obesity+4 more
Recruiting
1
Phase 4 / Post-Market1 trial
Bardet Biedl Syndrome (BBS)+3 more
Recruiting
1
Other1 trial
Obesity, Childhood+4 more
Recruiting

Rhythm Pharmaceuticals Clinical Trials (6)

Active and recruiting clinical trials sponsored by Rhythm Pharmaceuticals, sourced live from ClinicalTrials.gov. Each trial card shows the study phase, current recruitment status, conditions under investigation, study locations, eligibility criteria, and a direct link to the full ClinicalTrials.gov record. You can also download a one-page PDF summary to share with your doctor.

Note: Recruitment statuses on ClinicalTrials.gov may not immediately reflect recent FDA decisions, sponsor announcements, or enrollment changes. Always confirm a trial's current status directly with the study coordinator.

Ask about Rhythm Pharmaceuticals's trials
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ACTIVE NOT RECRUITINGPHASE3Recently updatedNCT05774756

A Trial of Setmelanotide in Acquired Hypothalamic Obesity

Intervention: Setmelanotide, Placebo

Hypothalamic Obesity

The goal of this trial is to learn how well Setmelanotide works to improve weight reduction, hunger, and quality of life in patients 4 years of age and older with acquired Hypothalamic Obesity (HO). To determine how well setmelanotide works and how safe it is, patients with HO will take a daily injection of either setmelanotide or placebo and complete trial assessments for 52 weeks on a therapeutic regimen. A separate sub-study in patients with congenital HO is detailed under NCT06760546.

Ages 4 Years+28 locations
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RECRUITINGPHASE4Updated a few months agoNCT07674290

Real-World Effects of MC4R Agonist Therapy in BBS and Severe Genetic Obesity

Intervention: Setmelanotide

Bardet Biedl Syndrome (BBS)Bardet Biedl SyndromeBardet-Biedl Syndrome (BBS)Alstrom Syndrome

Bardet-Biedl syndrome (BBS) and other rare disorders associated with impairment of the melanocortin-4 receptor (MC4R) pathway are characterized by severe early-onset obesity, hyperphagia, and substantial morbidity. Setmelanotide, an MC4R agonist, is approved in Europe for selected genetic obesity disorders and reimbursed in Germany for eligible patients. This study aims to evaluate the effectiveness, safety, treatment persistence, metabolic outcomes, and patient-reported outcomes of Setmelanotide under real-world conditions. The registry is designed to allow future inclusion of additional MC4R agonists as they become approved and clinically available. The study will primarily be conducted at University Hospital Essen and will collect longitudinal routine clinical data from pediatric and adult patients receiving MC4R agonist therapy according to approved indications.

Ages not specified1 location
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ACTIVE NOT RECRUITINGPHASE2No updates in a whileNCT06772597

A Study of Setmelanotide in Patients With Prader-Willi Syndrome

Intervention: Setmelanotide

Prader-Willi SyndromeObesityHyperphagia

This is a Phase 2, open-label study designed to assess the safety and efficacy of setmelanotide in patients with obesity due to Prader-Willi Syndrome (PWS) who are 6 to 65 years of age. Up to 20 patients are planned to be enrolled. Patients will take a daily subcutaneous dose of open-label setmelanotide for up to 52 weeks.

Ages 6 Years - 65 Years1 location
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RECRUITINGPHASE3No updates in a whileNCT06760546

A Trial of Setmelanotide in Patients With Congenital Hypothalamic Obesity (Sub-study of NCT05774756)

Intervention: Setmelanotide, Placebo

Hypothalamic ObesityMultiple Pituitary Hormone Deficiency Genetic FormSepto-Optic DysplasiaOptic Nerve HypoplasiaChildhood-onset Combined Pituitary Hormone Deficiency

This is a sub-study of Study RM-493-040 (NCT05774756). The goal of this sub-study is to learn how well Setmelanotide works to improve weight reduction, hunger, and quality of life in patients 4 years of age and older with congenital Hypothalamic Obesity (cHO). To determine how well setmelanotide works and how safe it is, patients with cHO will take a daily injection of either setmelanotide or placebo and complete trial assessments for up to 26 weeks on a therapeutic regimen.

Ages 4 Years+11 locations
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RECRUITINGPHASE1, PHASE2No updates in a whileNCT06239116

A Study of RM-718 in Healthy Subjects and Patients With MC4R Pathway Impairment

Intervention: Part A: RM-718 or placebo (matched to specific RM-718 dose cohort), Part B: RM-718 or placebo (matched to specific RM-718 dose cohort), Part C: RM-718, Part D: RM-718

Hypothalamic ObesityPrader-Willi SyndromePWS

The purpose of this study is to evaluate the safety, tolerability, and PK of RM-718 in healthy subjects with obesity and in patients with MC4R Pathway Impairment

Ages 12 Years - 65 Years7 locations
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ACTIVE NOT RECRUITINGNo updates in a whileNCT06239064

Early Genetic Identification of Obesity

Intervention: Genetic testing via blood collection

Obesity, ChildhoodHyperphagiaRetinopathySyndactylyPolydactyly

TITLE: Whole genetic approach in Early Genetic Identification of Obesity (WEGIO) DESIGN: Multicenter epidemiological study STUDY POPULATION: Participants at risk for a syndromic or a monogenic genetic obesity, incl. participants clinically diagnosed with Bardet-Biedl-Syndrome (BBS) NUMBER OF PARTICIPANTS: 1000 for initial genetic sequencing and app. 40 for the follow-up documentation COORDINATING INVESTIGATOR: Prof. Dr. Arndt Rolfs

Ages 2 Years+37 locations
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Rhythm Pharmaceuticals FDA-Approved Drugs (1)

Medications developed or marketed by Rhythm Pharmaceuticals that have received U.S. Food and Drug Administration approval. Drug data is sourced from the openFDA database and includes brand names, generic names, approval dates, and matched rare disease indications. Where a drug treats a condition covered by Trial Friend, the disease name links directly to that disease page.

Drug NameBrand NameRare DiseasesApproval Date
SETMELANOTIDE
Melanocortin 4 Receptor Agonist [EPC]
Imcivree
subcutaneous
Nov 25, 2020

Rhythm Pharmaceuticals Trial Locations

Rhythm Pharmaceuticals clinical trials are running at 85 sites in 6 countries. Click any country to drill down by state, city, and individual research facility. Proximity to a trial site is one of the most important factors in deciding whether to participate.

Germany
42▼
United States
32▼
United Kingdom
6▼
Japan
3▼
Canada
1▼
Netherlands
1▼

Rare Disease Focus Areas (3)

Diseases targeted by Rhythm Pharmaceuticals's clinical trial and drug development programs

Patient Resources

Organizations and resources related to Rhythm Pharmaceuticals's rare disease focus areas

Frequently Asked Questions About Rhythm Pharmaceuticals

Common questions about Rhythm Pharmaceuticals's rare disease programs, clinical trials, and treatments.