NCT06239116 A Study of RM-718 in Healthy Subjects and Patients With MC4R Pathway Impairment
| NCT ID | NCT06239116 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Rhythm Pharmaceuticals, Inc. |
| Condition | Hypothalamic Obesity |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2024-03-05 |
| Primary Completion | 2027-11-01 |
Trial Parameters
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Brief 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 MC4R Pathway Impairment
Eligibility Criteria
Key Inclusion Criteria: 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 i
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