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RHYTHM PHARMACEUTICALS, INC. (RYTM)

Rhythm Pharmaceuticals, Inc. is a biopharmaceutical company with commercial products, dedicated to the discovery, development, and market launch of therapies addressing rare genetic conditions that cause obesity. Its leading pharmaceutical, IMCIVREE, functions as a powerful agonist of the melanocortin-4 receptor (MC4R). This medication is indicated for treating obesity stemming from deficiencies in pro-opiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1), or the leptin receptor (LEPR), alongside its use in patients with Bardet-Biedl and Alström syndromes. Furthermore, the company is progressing setmelanotide (the active compound in IMCIVREE) through Phase II clinical trials. These studies are evaluating its potential for a broader spectrum of applications, including obesity caused by heterozygous POMC or LEPR deficiencies, steroid receptor coactivator 1 (SRC1) deficiency, SH2B1 deficiency, MC4 receptor deficiency, and obesity associated with Smith-Magenis syndrome, POMC epigenetic disorders, and other MC4R-related conditions. Rhythm Pharmaceuticals holds a collaborative research agreement with the Clinical Registry Investigating Bardet-Biedl Syndrome. The firm, headquartered in Boston, Massachusetts, was established in 2008 and changed its name from Rhythm Metabolic, Inc. to Rhythm Pharmaceuticals, Inc. in October 2015.

Sector: Pharmaceutical Preparations

Industry: Biotechnology

Rhythm Pharmaceuticals, Inc. logo

Rhythm Pharmaceuticals, Inc.

NASDAQ:RYTMHealthcare
-0.54%$92.57
AH$92.57+0.00%vs close
Mkt Cap$6.37B
Float64.39M
O/S68.85M
Vol
$ Vol
RVOL
Inst Own-
SI17.1%
Earnings
Dilution
Rhythm Pharmaceuticals, Inc. logoNASDAQ:RYTM$92.57-0.54%
Phase Distribution
29 lead-sponsored trials·5 active·23 completed
Phase 13
Phase 1/22
Phase 29
Phase 2/31
Phase 39
Phase 41
Not applicable4
(4 more as collaborator)
Status Overview
Recruiting2
Active, not recruiting3
Completed23
Expanded access1

Trials need funding. See this company's dilution risk and cash position.

Clinical Trials
Sponsor role
Status
Phase
  • Phase 4
    Completed

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

    Setmelanotide, Moxifloxacin

    Healthy

    Enrollment
    77
    Start
    Aug 2021
    Primary Completion
    Apr 2022
    Completion
    Apr 2022
    NCT05046132
  • Phase 3
    Completed

    Setmelanotide for the Treatment of Early-Onset Pro-Opiomelanocortin (POMC) Deficiency Obesity

    Setmelanotide, Placebo

    Pro-opiomelanocortin (POMC) Deficiency Obesity

    Enrollment
    15
    Start
    Feb 2017
    Primary Completion
    May 2020
    Completion
    May 2020
    NCT02896192
  • Phase 3
    Completed

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

    Setmelanotide, Placebo

    Leptin Receptor Deficiency Obesity

    Enrollment
    15
    Start
    Jan 2018
    Primary Completion
    Sep 2020
    Completion
    Sep 2020
    NCT03287960
  • Phase 3
    Completed

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

    Setmelanotide, Placebo

    Bardet Biedl Syndrome (BBS), Alström Syndrome (AS)

    Enrollment
    52
    Start
    Nov 2018
    Primary Completion
    Nov 2020
    Completion
    Mar 2021
    NCT03746522
  • Phase 3
    Completed

    Setmelanotide in Pediatric Participants With Rare Genetic Diseases of Obesity

    Setmelanotide

    Bardet-Biedl Syndrome, POMC Deficiency Obesity +2

    Enrollment
    12
    Start
    Mar 2022
    Primary Completion
    Sep 2023
    Completion
    Nov 2024
    NCT04966741
  • Phase 3
    Completed

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

    Setmelanotide, Placebo

    Obesity, Genetic Obesity

    Enrollment
    296
    Start
    Dec 2021
    Primary Completion
    Dec 2025
    Completion
    Jun 2026
    NCT05093634
  • Phase 3
    Completed

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

    Setmelanotide 2 mg, Setmelanotide 2.5 mg

    Bardet-Biedl Syndrome, POMC Deficiency

    Enrollment
    19
    Start
    Dec 2021
    Primary Completion
    Oct 2023
    Completion
    Oct 2023
    NCT05194124
  • Phase 3
    Active, not recruiting

    A Trial of Setmelanotide in Acquired Hypothalamic Obesity

    Setmelanotide, Placebo

    Hypothalamic Obesity

    Enrollment
    143
    Start
    Apr 2023
    Primary Completion
    Mar 2025
    Completion
    Apr 2027est.
    NCT05774756
  • Phase 3
    Completed

    Open-Label Extension Study of Setmelanotide

    Setmelanotide

    Obesity Associated With Defects in Leptin-melanocortin Pathway

    Enrollment
    28
    Start
    Oct 2024
    Primary Completion
    Jun 2026
    Completion
    Jun 2026
    NCT06596135
  • Phase 3
    Recruiting

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

    Setmelanotide, Placebo

    Hypothalamic Obesity, Multiple Pituitary Hormone Deficiency Genetic Form +4

    Enrollment
    39
    Start
    Sep 2025
    Primary Completion
    Mar 2027est.
    Completion
    Mar 2028est.
    NCT06760546
  • Phase 2/3
    Completed

    Long Term Extension Trial of Setmelanotide

    Setmelanotide

    Obesity Associated With Defects in Leptin-melanocortin Pathway

    Enrollment
    205
    Start
    Jul 2018
    Primary Completion
    Jan 2025
    Completion
    Jan 2025
    NCT03651765
  • Phase 2
    Completed

    Phase 2 Study to Evaluate Safety and Efficacy of RM-493 in Obese Participants

    Setmelanotide, Placebo

    Overweight

    Enrollment
    74
    Start
    Jan 2013
    Primary Completion
    Sep 2013
    Completion
    Sep 2013
    NCT01749137
  • Phase 2
    Completed

    Phase 2 Trial to Evaluate Safety and Efficacy of Setmelanotide (RM-493) in Obese Participants With Prader-Willi Syndrome

    Setmelanotide, Placebo

    Prader-Willi Syndrome

    Enrollment
    40
    Start
    Mar 2015
    Primary Completion
    Oct 2016
    Completion
    Oct 2016
    NCT02311673
  • Phase 2
    Completed

    Setmelanotide Phase 2 Treatment Trial in Participants With Rare Genetic Disorders of Obesity

    Setmelanotide

    Genetic Obesity, Obesity +1

    Enrollment
    213
    Start
    Feb 2017
    Primary Completion
    Mar 2022
    Completion
    Mar 2022
    NCT03013543
  • Phase 2
    Completed

    Setmelanotide in a Single Patient With Partial Lipodystrophy

    Setmelanotide

    Hypertriglyceridemia, Obesity

    Enrollment
    1
    Start
    Aug 2017
    Primary Completion
    Jan 2018
    Completion
    Jan 2018
    NCT03262610
  • Phase 2
    Completed

    Open-Label Study of Setmelanotide in Hypothalamic Obesity

    Setmelanotide

    Hypothalamic Obesity

    Enrollment
    18
    Start
    Jun 2021
    Primary Completion
    Jun 2022
    Completion
    Jun 2022
    NCT04725240
  • Phase 2
    Completed

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

    Setmelanotide, Placebo

    Genetic Obesity

    Enrollment
    164
    Start
    Nov 2021
    Primary Completion
    Aug 2023
    Completion
    Sep 2024
    NCT04963231
  • Phase 2
    Completed

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

    Bivamelagon, Placebo

    Hypothalamic Obesity

    Enrollment
    28
    Start
    Jul 2024
    Primary Completion
    Feb 2026
    Completion
    Feb 2026
    NCT06046443
  • Phase 2
    Active, not recruiting

    A Study of Setmelanotide in Patients With Prader-Willi Syndrome

    Setmelanotide

    Prader-Willi Syndrome, Obesity +1

    Enrollment
    18
    Start
    Mar 2025
    Primary Completion
    Oct 2026est.
    Completion
    Oct 2027est.
    NCT06772597
  • Phase 2
    Enrolling by invitation

    A Long-Term Study of Bivamelagon in Participants With Hypothalamic Obesity (HO)

    Bivamelagon

    Hypothalamic Obesity

    Enrollment
    25
    Start
    Nov 2025
    Primary Completion
    Apr 2028est.
    Completion
    Apr 2028est.
    NCT07156578
  • Phase 1/2
    Completed

    Phase 1b/2a Study to Evaluate Safety and Efficacy of Setmelanotide in Obese Patients

    Setmelanotide, Placebo

    Overweight and Obesity

    Enrollment
    99
    Start
    Jan 2014
    Primary Completion
    Aug 2014
    Completion
    Dec 2014
    NCT02041195
  • Phase 1/2
    Active, not recruiting

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

    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)

    Hypothalamic Obesity, Prader-Willi Syndrome +1

    Enrollment
    111
    Start
    Mar 2024
    Primary Completion
    May 2027est.
    Completion
    Nov 2028est.
    NCT06239116
  • Phase 1
    Completed

    Effects of RM-493 on Energy Expenditure in Obese Individuals

    Placebo, RM-493

    Obesity, Morbid Obesity

    Enrollment
    15
    Start
    May 2013
    Primary Completion
    Mar 2014
    Completion
    Mar 2014
    NCT01867437
  • Phase 1
    Completed

    Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RM-493 Administered to Healthy, Obese, Non-diabetic Volunteers

    RM-493, Placebo

    Overweight, Obese

    Enrollment
    57
    Start
    Jan 2012
    Primary Completion
    Jan 2014
    Completion
    Jan 2014
    NCT02431442
  • Phase 1
    Completed

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

    Setmelanotide

    Renal Insufficiency

    Enrollment
    32
    Start
    Jul 2020
    Primary Completion
    Apr 2021
    Completion
    Apr 2021
    NCT04348175

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