A Study of RM-718 Weekly Formulation in Healthy Subjects With Obesity and in Patients With Hypothalamic Obesity (HO)

Status: Recruiting
Location: See all (7) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

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 hypothalamic obesity (HO).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Maximum Age: 65
Healthy Volunteers: t
View:

∙ Parts A and B:

• Male and female subjects in good health aged 18-55 years of age at Screening.

• Body mass index (BMI) ≥30 kg/m2.

• Subjects who are medically healthy with normal or clinically insignificant screening results.

• Subjects must use a highly effective form of contraception and follow the study contraception requirements.

• Ability to communicate well with the Investigator, understand and comply with the requirements of the trial, and understand English and sign the written informed consent.

∙ Part C:

• Male and female patients with HO, aged 12-65 years of age at Screening.

• Patient has documented evidence of acquired HO defined as:

‣ Diagnosis of craniopharyngioma or other brain lesion affecting the hypothalamic region and has undergone surgery, or chemotherapy, or radiation therapy involving the hypothalamus at least 6 months before Screening, OR

⁃ Documented injury to the hypothalamus at least 6 months before Screening for which surgery/radiation is not indicated.

• Weight gain associated with the hypothalamic injury either before or following therapy (surgery and/or following chemotherapy or radiotherapy), and a BMI of ≥30 kg/m2 for patients ≥18 years of age or BMI ≥95th percentile for age and sex for patients 12 to \<18 years of age.

• Patients must use a highly effective form of contraception and follow the study contraception requirements.

• Ability to communicate with the Investigator, understand and comply with the requirements of the trial, and understand and sign the written informed consent and assent (for patients aged \<18 years), and informed consent for a parent or guardian of any patient \<18.

Locations
United States
Alabama
UAB Pediatric Endocrinology
RECRUITING
Birmingham
Illinois
Ann and Robert H. Lurie Children's Hospital of Chicago
RECRUITING
Chicago
Massachusetts
Boston Children's Hospital
NOT_YET_RECRUITING
Boston
Brigham and Women's Hospital
RECRUITING
Boston
Tennessee
Vanderbilt University Medical Center
RECRUITING
Nashville
Texas
Worldwide Clinical Trials
COMPLETED
San Antonio
Utah
University of Utah Pediatric Endocrine Clinic
RECRUITING
Salt Lake City
Contact Information
Primary
Rhythm Clinical Trials
clinicaltrials@rhythmtx.com
(857) 264-4280
Backup
Physician Inquiry Clinical Trials
clinicaltrials@rhythmtx.com
(857) 264-4280
Time Frame
Start Date: 2024-03-05
Estimated Completion Date: 2026-05-04
Participants
Target number of participants: 120
Treatments
Experimental: RM-718 (Cohort A1)
Single dose of RM-718 (4) or placebo (2)
Experimental: RM-718 (Cohort A2)
Single dose of RM-718 (4) or placebo (2)
Experimental: RM-718 (Cohort A3)
Single dose of RM-718 (4) or placebo (2)
Experimental: RM-718 (Cohort A4)
Single dose of RM-718 (4) or placebo (2)
Experimental: RM-718 (Cohort A5)
Single dose of RM-718 (4) or placebo (2)
Experimental: RM-718 (Cohort A6)
Single dose of RM-718 (4) or placebo (2)
Experimental: RM-718 (Cohort B1)
Multiple doses of RM-718 (4) or placebo (2)
Experimental: RM-718 (Cohort B2)
Multiple ascending doses of RM-718 (4) or placebo (2)
Experimental: RM-718 (Cohort B3)
Multiple ascending doses of RM-718 (4) or placebo (2)
Experimental: RM-718 (Cohort B4)
Multiple ascending doses of RM-718 (4) or placebo (2)
Experimental: RM-718 (Cohort B5)
Multiple ascending doses of RM-718 (4) or placebo (2)
Experimental: RM-718 (Cohort C1)
Multiple ascending doses of RM-718 (30)
Experimental: RM-718 (Cohort B6)
Multiple ascending doses of RM-718 (4) or placebo (2)
Related Therapeutic Areas
Sponsors
Leads: Rhythm Pharmaceuticals, Inc.

This content was sourced from clinicaltrials.gov