Setmelanotide

Generic Name: Setmelanotide

Brand Names: Imcivree

Drug Type: Small Molecule

Chemical Formula: C_₄₉H_₆₈N_₁₈O_₉S_₂

CAS Number: 920014-72-8

Unique Ingredient Identifier: N7T15V1FUY

Background: Setmelanotide is the first available treatment for patients with pro-opiomelanocortin, proprotein subilisin/kexin type 1, or leptin deficiencies. It is an agonist of the melanocortin 4 receptor. Earlier attempts at agonizing MC4R (such as LY2112688) lead to successful weight loss, but also an increase in blood pressure and heart rate. Other earlier treatment...

Indication: Setmelanotide is indicated for chronic weight management in patients 6 years and older with obesity due to pro-opiomelanocortin (POMC) deficiency, proprotein subtilisin/kexin type 1 (PCSK1) deficiency, or leptin receptor (LEPR) deficiency as determined by an approved test demonstrating variants in POMC, PCSK1, or LEPR genes that are interpreted as pathogenic...

Associated Conditions: Leptin Receptor Deficiency Obesity, Obesity, Pro-opiomelanocortin (POMC) Deficiency Obesity, Proprotein convertase subtilisin/kexin type 1 (PCSK1) deficiency obesity

Associated Therapies: Chronic Weight Management therapy

Clinical Trials

Open-Label Extension Study of Setmelanotide

Phase 3

Conditions: Obesity Associated With Defects in Leptin-melanocortin Pathway

Interventions: Drug: Setmelanotide

First Posted Date: 2024-09-19

Last Posted Date: 2024-11-13

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 Trial of Setmelanotide in Acquired Hypothalamic Obesity

Phase 3

Conditions: Hypothalamic Obesity

Interventions: Drug: Placebo
Drug: Setmelanotide

First Posted Date: 2023-03-20

Last Posted Date: 2024-12-20

Lead Sponsor: Rhythm Pharmaceuticals, Inc.

Target Recruit Count: 120

Registration Number: NCT05774756

Locations: 🇬🇧
Birmingham Women and Children's Hospital NHS Trust, Birmingham, United Kingdom
🇺🇸
UAN Pediatric Endocrinology, Birmingham, Alabama, United States
🇺🇸
Rady Children's Hospital, San Diego, California, United States

and more 25 locations

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

Phase 3

Recruiting

Conditions: Genetic Obesity
Obesity

Interventions: Drug: Setmelanotide
Drug: Placebo

First Posted Date: 2021-10-26

Last Posted Date: 2024-11-08

Lead Sponsor: Rhythm Pharmaceuticals, Inc.

Target Recruit Count: 400

Registration Number: NCT05093634

Locations: 🇺🇸
UPMC Montefiore, Pittsburgh, Pennsylvania, United States
🇺🇸
Marshfield Clinic Research Foundation, a Division of Marshfield Clinic, Inc, Marshfield, Wisconsin, United States
🇵🇷
University of Puerto Rico, San Juan, Puerto Rico

and more 53 locations

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

Phase 4

Completed

Conditions: Healthy

Interventions: Drug: Moxifloxacin
Drug: Setmelanotide
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

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: Drug: Setmelanotide

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: Setmelanotide
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: Drug: Setmelanotide

First Posted Date: 2021-01-26

Last Posted Date: 2023-09-21

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: Drug: Setmelanotide

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
Drug: Setmelanotide

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

Active, not recruiting

Conditions: Obesity Associated With Defects in Leptin-melanocortin Pathway

Interventions: Drug: Setmelanotide

First Posted Date: 2018-08-29

Last Posted Date: 2024-10-28

Lead Sponsor: Rhythm Pharmaceuticals, Inc.

Target Recruit Count: 300

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

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