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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.

A Single-center Study of Setmelanotide in Patients With Prader-Willi Syndrome

Phase 2
Recruiting
Conditions
Prader-Willi Syndrome
Obesity
Hyperphagia
Interventions
First Posted Date
2025-01-13
Last Posted Date
2025-03-19
Lead Sponsor
Rhythm Pharmaceuticals, Inc.
Target Recruit Count
20
Registration Number
NCT06772597
Locations
🇺🇸

University of Florida, Gainesville, Florida, United States

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

Phase 3
Not yet recruiting
Conditions
Hypothalamic Obesity
Multiple Pituitary Hormone Deficiency Genetic Form
Septo-Optic Dysplasia
Optic Nerve Hypoplasia
Childhood-onset Combined Pituitary Hormone Deficiency
Pituitary Stalk Interruption Syndrome
Interventions
Drug: Placebo
First Posted Date
2025-01-07
Last Posted Date
2025-03-21
Lead Sponsor
Rhythm Pharmaceuticals, Inc.
Target Recruit Count
39
Registration Number
NCT06760546

Open-Label Extension Study of Setmelanotide

Phase 3
Conditions
Obesity Associated With Defects in Leptin-melanocortin Pathway
Interventions
First Posted Date
2024-09-19
Last Posted Date
2025-05-16
Lead Sponsor
Rhythm Pharmaceuticals, Inc.
Target Recruit Count
30
Registration Number
NCT06596135
Locations
🇺🇸

HonorHealth Research Institute, Scottsdale, Arizona, United States

🇺🇸

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

🇺🇸

University of Florida at Gainesville, Gainesville, Florida, United States

and more 10 locations

A Study of RM-718 in Healthy Subjects and in Patients With HO

Phase 1
Recruiting
Conditions
Hypothalamic Obesity
First Posted Date
2024-02-02
Last Posted Date
2025-05-09
Lead Sponsor
Rhythm Pharmaceuticals, Inc.
Target Recruit Count
120
Registration Number
NCT06239116
Locations
🇺🇸

UAB Pediatric Endocrinology, Birmingham, Alabama, United States

🇺🇸

Ann and Robert H. Lurie Children's Hospital of Chicago, Chicago, Illinois, United States

🇺🇸

Boston Children's Hospital, Boston, Massachusetts, United States

and more 4 locations

A Study to Assess Efficacy and Safety of LB54640 in Patients With Hypothalamic Obesity

Phase 2
Active, not recruiting
Conditions
Hypothalamic Obesity
Interventions
Drug: Placebo
First Posted Date
2023-09-21
Last Posted Date
2025-03-03
Lead Sponsor
Rhythm Pharmaceuticals, Inc.
Target Recruit Count
28
Registration Number
NCT06046443
Locations
🇺🇸

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

🇺🇸

University of Iowa Children's Hospital, Iowa City, Iowa, United States

🇺🇸

Tufts Medical Center, Boston, Massachusetts, United States

and more 7 locations

A Trial of Setmelanotide in Acquired Hypothalamic Obesity

Phase 3
Active, not recruiting
Conditions
Hypothalamic Obesity
Interventions
Drug: Placebo
First Posted Date
2023-03-20
Last Posted Date
2025-04-17
Lead Sponsor
Rhythm Pharmaceuticals, Inc.
Target Recruit Count
120
Registration Number
NCT05774756
Locations
🇬🇧

Birmingham Women and Children's Hospital NHS Trust, Birmingham, United Kingdom

🇺🇸

Ohio State Wexner Medical Center, Columbus, Ohio, United States

🇺🇸

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

and more 25 locations

Phase 3 Crossover Trial of Two Formulations of Setmelanotide in Participants With Specific Gene Defects in the MC4R Pathway

First Posted Date
2022-01-18
Last Posted Date
2024-11-26
Lead Sponsor
Rhythm Pharmaceuticals, Inc.
Target Recruit Count
19
Registration Number
NCT05194124
Locations
🇵🇷

UPR Medical Sciences Campus, Rio Piedras, Puerto Rico

🇳🇱

Erasmus MC, Rotterdam, Netherlands

🇩🇪

Charité - Universitätsmedizin Berlin, Campus Virchow-Klinikum, Berlin, Germany

and more 4 locations

An Expanded Access Protocol for Setmelanotide for Treatment of Bardet-Biedl Syndrome (BBS)

Conditions
Bardet-Biedl Syndrome (BBS)
Obesity
First Posted Date
2022-01-11
Last Posted Date
2022-08-10
Lead Sponsor
Rhythm Pharmaceuticals, Inc.
Registration Number
NCT05183802

EMANATE: A Study of Setmelanotide in Patients With Specific Gene Variants in the MC4R Pathway

Phase 3
Active, not recruiting
Conditions
Genetic Obesity
Obesity
Interventions
Drug: Placebo
First Posted Date
2021-10-26
Last Posted Date
2025-05-09
Lead Sponsor
Rhythm Pharmaceuticals, Inc.
Target Recruit Count
400
Registration Number
NCT05093634
Locations
🇺🇸

Phoenix Children's Hospital, Phoenix, Arizona, United States

🇺🇸

HonorHealth Bariatric Center, Scottsdale, Arizona, United States

🇺🇸

Children's Hospital Los Angeles, Los Angeles, California, United States

and more 53 locations

Study of Setmelanotide Effects on QTc (Corrected QT) Interval in Healthy Participants

Phase 4
Completed
Conditions
Healthy
Interventions
Drug: Oral Placebo
Drug: SC Placebo
First Posted Date
2021-09-16
Last Posted Date
2024-05-03
Lead Sponsor
Rhythm Pharmaceuticals, Inc.
Target Recruit Count
77
Registration Number
NCT05046132
Locations
🇺🇸

Parexel Early Phase Clinical Unit (Los Angeles), Glendale, California, United States

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