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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Rhythm Pharmaceuticals, Inc.
Study ID
NCT06760546
Phase
PHASE3
Status
Recruiting
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Conditions

  • Childhood-onset Combined Pituitary Hormone Deficiency
  • Hypothalamic Obesity
  • Multiple Pituitary Hormone Deficiency Genetic Form
  • Optic Nerve Hypoplasia
  • Pituitary Stalk Interruption Syndrome
  • Septo-Optic Dysplasia

Eligibility Criteria

Sex
ALL
Age
4 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Setmelanotide — DRUG
    Solution for daily subcutaneous injection
  • Placebo — DRUG
    Placebo matched to setmelanotide for daily subcutaneous injection

Study Details

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.

Key Dates

Start date
Sep 23, 2025
Status verified
Feb 2026
Primary completion
Mar 13, 2027
Completion
Mar 13, 2028

Study Design

Enrollment
39 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Setemelanotide
    Randomized 2:1 (Setmelanotide: Placebo)
  • Placebo Comparator: Placebo
    Randomized 2:1 (Setmelanotide: Placebo)

Primary Outcome Measure

Mean % change in BMI [ Time Frame: From Baseline after 26 weeks on a therapeutic regimen ]

Central Contacts

Locations (8)

FacilityCityStateZIPSite coordinators
University of AlabamaBirminghamAlabama35233-
Children's Hospital ColoradoAuroraColorado80045-
Lurie Children's HospitalChicagoIllinois60611-
Boston Children's HospitalBostonMassachusetts02115-
Children's MinnesotaSaint PaulMinnesota55102-
Columbia University Irving Medical CenterNew YorkNew York10032-
Children's Hospital of PhiladelphiaPhiladelphiaPennsylvania19104-
Seattle Children's Research InstituteSeattleWashington98105-

Find similar trials in Birmingham, AL

By research site
University of Alabama· Birmingham, ALChildren's Hospital Colorado· Aurora, COLurie Children's Hospital· Chicago, ILBoston Children's Hospital· Boston, MAChildren's Minnesota· Saint Paul, MNColumbia University Irving Medical Center· New York, NY

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