Open-Label Study of Setmelanotide in Hypothalamic Obesity (NCT04725240) | Clinical Trial Compass
CompletedPhase 2
Open-Label Study of Setmelanotide in Hypothalamic Obesity
United States18 participantsStarted 2021-06-07
Plain-language summary
Open-label, single-arm study designed to evaluate the body weight response to setmelanotide administered subcutaneously (SC) daily in participants with hypothalamic obesity (HO).
Who can participate
Age range6 Years – 40 Years
SexALL
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Inclusion Criteria:
Participants must meet all of the following criteria to be eligible for study participation:
* Participant has documented evidence of HO, including:
* Recent evidence of hypothalamic injury on magnetic resonance imaging (MRI); AND
* Diagnosis of craniopharyngioma or other non-malignant brain tumor affecting the hypothalamic region; AND
* Has undergone surgery, or chemotherapy, or radiation ≥6 months and ≤15 years before Screening.
* Participant has either unilateral hypothalamic lesions or bilateral hypothalamic lesions, as assessed by MRI.
* Obesity, documented by a body mass index (BMI) ≥35 kilograms/square meter (kg/m\^2) for participants ≥18 years of age or BMI ≥95th percentile for age and gender for participants 6 to \<18 years of age.
* Documented increase in BMI (change from pre-surgery baseline in BMI z-score ≥0.2 for participants \<18 years of age or BMI \>5% for participants \>18 years of age) either during the first 6 months following surgery or within 1 year before surgery AND still present at Screening.
* More than 6 months after the end of post-tumor treatment, including chemotherapy, surgery, or radiation.
* Highly effective contraception throughout the study and for 90 days following the study.
* Ability to communicate well with the Investigator, understand and comply with the requirements of the study, and understand and sign the written informed consent, or, for participants aged \<18 years, a parent/legal guardian that can sign.…
What they're measuring
1
Percentage of Participants With ≥ 5% Reduction in BMI From Baseline After 16 Weeks of Setmelanotide Treatment