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This is a long-term, open-label extension study of bivamelagon in participants with Hypothalamic Obesity (HO) who have transitioned from the index study, LG-MCCL005. The study will last up to 2 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bivamelagon (open-label) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bivamelagon | Drug | daily dose of oral bivamelagon |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of bivamelagon as assessed by the number and frequency of AEs | Baseline to up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change and mean percentage change from Baseline in BMI in participants ≥18 years of age. | Baseline to up to 2 years | |
| Mean change in BMI z-score in participants >18 years of age. | Baseline to up to 2 years |
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Key Inclusion Criteria:
Key Exclusion Criteria:
Other protocol defined Inclusion/Exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| David Meeker, MD | Rhythm Pharmaceuticals, Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital Colorado | Aurora | Colorado | 80045 | United States | ||
| University of Iowa Children's Hospital |
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| Mean change in and mean percentage change in weight | Baseline to up to 2 years |
| Mean change in percentage of the 95th percentile of BMI in participants <18 years of age. | Baseline to up to 2 years |
| Percentage of patients who achieve ≥5%,≥10%, ≥15%, and ≥20% reduction in BMI from baseline | Baseline to up to 2 years |
| Mean change from Baseline in Physical function (and total score) for the Impact of Weight on Quality of Life-Lite (IWQoL) in participants ≥18 years of age | Baseline to up to 2 years |
| Change from Baseline in total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, and triglycerides | Baseline to up 2 years |
| Iowa City |
| Iowa |
| 52242 |
| United States |
| Tufts Medical Center | Boston | Massachusetts | 02111 | United States |
| Columbia University | New York | New York | 10027 | United States |
| The University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27514 | United States |
| St. Jude Children's Research Hospital | Memphis | Tennessee | 38105 | United States |
| Birmingham Women's and Children's NHS Foundation Trust | Birmingham | B15 2TG | United Kingdom |
| University of Cambridge | Cambridge | CB2 1TN | United Kingdom |
| Great Ormond Street Hospital for Children | London | WC1N 3JH | United Kingdom |
| ID | Term |
|---|---|
| D050035 | Sexual Infantilism |
| ID | Term |
|---|---|
| D006059 | Gonadal Dysgenesis |
| D012734 | Disorders of Sex Development |
| D014564 | Urogenital Abnormalities |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
| D007006 | Hypogonadism |
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