Actively Recruiting
A Study of RM-718 in Healthy Subjects and Patients With MC4R Pathway Impairment
Led by Rhythm Pharmaceuticals, Inc. · Updated on 2025-12-22
150
Participants Needed
7
Research Sites
243 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to evaluate the safety, tolerability, and PK of RM-718 in healthy subjects with obesity and in patients with MC4R Pathway Impairment
CONDITIONS
Official Title
A Study of RM-718 in Healthy Subjects and Patients With MC4R Pathway Impairment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- For Parts A and B: Male and female healthy adults aged 18 to 55 years
- BMI of 30 kg/m2 or higher for Parts A and B
- Medically healthy with normal or insignificant screening results for Parts A and B
- Use of highly effective contraception and agreement to follow contraception requirements
- Ability to communicate, understand the trial, and provide informed consent in English for Parts A and B
- For Part C: Male and female patients aged 12 to 65 years with documented acquired hypothalamic obesity
- Documented brain lesion affecting hypothalamus with prior surgery, chemotherapy, or radiation at least 6 months before screening (Part C)
- Weight gain related to hypothalamic injury and BMI 30 kg/m2 or higher if 18 or older, or BMI at/above 95th percentile for age and sex if 12 to under 18 (Part C)
- Use of highly effective contraception and agreement to follow contraception requirements (Part C)
- Ability to communicate, understand the trial, and provide informed consent/assent (and parental consent if under 18) for Part C
- For Part D: Confirmed diagnosis of Prader-Willi syndrome
- Age 12 to 65 years inclusive
- BMI 30 kg/m2 or higher if 18 or older, or at/above 95th percentile for age and sex if under 18
- Ability to meet contraception requirements
You will not qualify if you...
- For Parts A and B: Clinically significant abnormalities on labs or exam
- History or active significant medical conditions including renal, hepatic, pulmonary, gastrointestinal, cardiovascular, genitourinary, endocrine, immunologic, metabolic, neurologic, or hematological disease
- Obesity due to genetic, syndromic, or endocrine causes
- History of renal transplant or end-stage renal disease
- Severe psychiatric disorders
- Significant pulmonary, cardiac, metabolic, or oncologic diseases interfering with study
- Smoking or dependence on caffeine, alcohol, drugs; inability to abstain 24 hours before and after visits
- Recent surgery within 60 days
- Participation in other clinical trials with investigational drugs/devices within 3 months or 5 half-lives
- Pregnancy, breastfeeding, or desire to become pregnant during trial
- For Part C: Diagnosis of PWS or ROHHADNET
- Weight loss over 2% in last 3 months or use of anti-obesity medications
- Bariatric surgery or procedure within last 2 years
- Severe psychiatric disorders including suicidal ideation or behavior
- Significant diseases interfering with trial
- Renal transplant or end-stage renal disease
- Participation in other clinical trials or prior setmelanotide trial
- Pregnancy, breastfeeding, or desire to become pregnant during trial
- Obesity due to other genetic or syndromic conditions prior to hypothalamic injury
- For Part D: Weight loss over 2% in last 3 months or therapies for obesity or hyperphagia
- Metabolic or bariatric surgery within last 6 months
- Severe psychiatric disorders including suicidal ideation or behavior
- Significant diseases interfering with trial
- Pregnancy, breastfeeding, or desire to become pregnant during trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
UAB Pediatric Endocrinology (Part C and Part D)
Birmingham, Alabama, United States, 35233
Actively Recruiting
2
Ann and Robert H. Lurie Children's Hospital of Chicago (Part C and Part D)
Chicago, Illinois, United States, 60611
Actively Recruiting
3
Boston Children's Hospital (Part C only)
Boston, Massachusetts, United States, 021115
Actively Recruiting
4
Brigham and Women's Hospital (Part C and Part D)
Boston, Massachusetts, United States, 02115
Actively Recruiting
5
Vanderbilt University Medical Center (Part C only)
Nashville, Tennessee, United States, 37232
Actively Recruiting
6
Worldwide Clinical Trials (Part A and Part B)
San Antonio, Texas, United States, 78217
Completed
7
University of Utah Pediatric Endocrine Clinic (Part C and Part D)
Salt Lake City, Utah, United States, 84112
Actively Recruiting
Research Team
R
Rhythm Clinical Trials
CONTACT
P
Physician Inquiry Clinical Trials
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
17
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