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Rhythm Pharmaceuticals

Rhythm Pharmaceuticals logo
🇺🇸United States
Ownership
Public
Established
2010-02-01
Employees
226
Market Cap
-
Website
http://www.rhythmtx.com
Introduction

Rhythm Pharmaceuticals, Inc. is a commercial-stage biopharmaceutical company, which engages in the development and commercialization of therapeutics for patients with rare diseases. The firm offers IMCIVREE (setmelanotide), a precision medicine designed to treat hyperphagia and severe obesity caused by rare melanocortin-4 receptor (MC4R) diseases. It is also involved in the clinical development program for setmelanotide in other rare MC4R pathway diseases, as well as a preclinical suite of investigational candidates for the treatment of congenital hyperinsulinism. The company was founded by Bart Henderson in November 2008 and is headquartered in Boston, MA.

Setmelanotide in Pediatric Participants With Rare Genetic Diseases of Obesity

Phase 3
Completed
Conditions
Bardet-Biedl Syndrome
PCSK1 Deficiency Obesity
LEPR Deficiency Obesity
POMC Deficiency Obesity
Interventions
First Posted Date
2021-07-19
Last Posted Date
2024-11-27
Lead Sponsor
Rhythm Pharmaceuticals, Inc.
Target Recruit Count
12
Registration Number
NCT04966741
Locations
🇺🇸

Columbia University Medical Center, Division of Pediatric Endocrinology, Diabetes and Metabolism, New York, New York, United States

🇺🇸

Children's Hospital Colorado, Aurora, Colorado, United States

🇬🇧

Addenbrooke's Hospital, Wellcome Trust-MRC Institute of Metabolic Science, Cambridge, United Kingdom

and more 3 locations

DAYBREAK: A Study of Setmelanotide in Participants With Specific Gene Variants in the Melanocortin-4 Receptor (MC4R) Pathway

Phase 2
Completed
Conditions
Genetic Obesity
Interventions
Drug: Placebo
First Posted Date
2021-07-15
Last Posted Date
2024-11-08
Lead Sponsor
Rhythm Pharmaceuticals, Inc.
Target Recruit Count
164
Registration Number
NCT04963231
Locations
🇺🇸

Ten's Medical Center - Pediatric Endocrinology Clinic, Staten Island, New York, United States

🇺🇸

The Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States

🇺🇸

Endocrine Associates of Dallas and Plano, Dallas, Texas, United States

and more 33 locations

Open-Label Study of Setmelanotide in Hypothalamic Obesity

Phase 2
Completed
Conditions
Hypothalamic Obesity
Interventions
First Posted Date
2021-01-26
Last Posted Date
2025-02-07
Lead Sponsor
Rhythm Pharmaceuticals, Inc.
Target Recruit Count
18
Registration Number
NCT04725240
Locations
🇺🇸

Children's Minnesota, Saint Paul, Minnesota, United States

🇺🇸

Seattle Children's Research Institute, Seattle, Washington, United States

🇺🇸

Rady Children's Hospital, San Diego, California, United States

and more 2 locations

A Phase 1 Study to Evaluate the Pharmacokinetics of Setmelanotide in Subjects With Varying Degrees of Renal Impairment

Phase 1
Completed
Conditions
Renal Insufficiency
Interventions
First Posted Date
2020-04-16
Last Posted Date
2021-06-30
Lead Sponsor
Rhythm Pharmaceuticals, Inc.
Target Recruit Count
32
Registration Number
NCT04348175
Locations
🇺🇸

University of Miami, Miami, Florida, United States

🇺🇸

Alliance for Multispecialty Research, LLC, Knoxville, Tennessee, United States

🇺🇸

Orlando Clinical Research Center, Orlando, Florida, United States

and more 1 locations

Setmelanotide (RM-493), Melanocortin-4 Receptor (MC4R) Agonist, in Bardet-Biedl Syndrome (BBS) and Alström Syndrome (AS) Participants With Moderate to Severe Obesity

Phase 3
Completed
Conditions
Bardet Biedl Syndrome (BBS)
Alström Syndrome (AS)
Interventions
Drug: Placebo
First Posted Date
2018-11-19
Last Posted Date
2023-12-01
Lead Sponsor
Rhythm Pharmaceuticals, Inc.
Target Recruit Count
52
Registration Number
NCT03746522
Locations
🇺🇸

Wr-McCr, Llc, San Diego, California, United States

🇺🇸

Columbia University Center, New York, New York, United States

🇺🇸

M3 Wake Research, Raleigh, North Carolina, United States

and more 9 locations

Long Term Extension Trial of Setmelanotide

Phase 2
Completed
Conditions
Obesity Associated With Defects in Leptin-melanocortin Pathway
Interventions
First Posted Date
2018-08-29
Last Posted Date
2025-04-08
Lead Sponsor
Rhythm Pharmaceuticals, Inc.
Target Recruit Count
205
Registration Number
NCT03651765
Locations
🇺🇸

Obesity Institute, Geisinger Clinic, Danville, Pennsylvania, United States

🇺🇸

Wake Research, Raleigh, North Carolina, United States

🇺🇸

Wake Research TN, Chattanooga, Tennessee, United States

and more 24 locations

An Observational,Prospective Natural History Study of Early-Onset Extreme Obesity Due to Bi-Allelic Loss-of-Function Mutations in the POMC, PCSK1 or LEPR Genes

Completed
Conditions
PCSK1 Deficiency Obesity
LEPR Deficiency Obesity
POMC Deficiency Obesity
First Posted Date
2018-08-08
Last Posted Date
2021-06-30
Lead Sponsor
Rhythm Pharmaceuticals, Inc.
Target Recruit Count
8
Registration Number
NCT03621007
Locations
🇹🇷

Ege University School of Medicine of Pediatric Endocrinology, Bornova, Turkey

🇹🇷

Pediatric Endocrinology and Diabetes Marmara University Hospital, Istanbul, Turkey

🇹🇷

Dokuz Eylul Universitesi Tip Fakultesi, Balçova, Turkey

The TEMPO (Tracing the Effect of the MC4 Pathway in Obesity) Registry

Completed
Conditions
Genetic Forms of Extreme Obesity
First Posted Date
2018-03-27
Last Posted Date
2021-05-04
Lead Sponsor
Rhythm Pharmaceuticals, Inc.
Target Recruit Count
303
Registration Number
NCT03479437
Locations
🇺🇸

Nationwide Children's Hospital, Columbus, Ohio, United States

🇨🇦

University of Alberta, Edmonton, Canada

Setmelanotide for the Treatment of Leptin Receptor (LEPR) Deficiency Obesity

Phase 3
Completed
Conditions
Leptin Receptor Deficiency Obesity
Interventions
Drug: Placebo
First Posted Date
2017-09-19
Last Posted Date
2023-05-23
Lead Sponsor
Rhythm Pharmaceuticals, Inc.
Target Recruit Count
15
Registration Number
NCT03287960
Locations
🇳🇱

Erasmus Medical Center, Rotterdam, Netherlands

🇩🇪

University of Ulm, Ulm, Germany

🇨🇦

Markham Stouffville Hospital, Markham, Ontario, Canada

and more 3 locations

Setmelanotide in a Single Patient With Partial Lipodystrophy

Phase 2
Completed
Conditions
Hypertriglyceridemia
Obesity
Interventions
First Posted Date
2017-08-25
Last Posted Date
2022-01-04
Lead Sponsor
Rhythm Pharmaceuticals, Inc.
Target Recruit Count
1
Registration Number
NCT03262610
Locations
🇺🇸

University of Michigan, Ann Arbor, Michigan, United States

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