Clinical trial
Setmelanotide to Treat Obesity in a Patient With Pseudohypoparathyroidism Type 1a (PHP1a)
Invitation only · Phase 2 · 1 countries · Registry ID NCT07496463
Invitation onlyPhase 2Interventional
What this study is about
The investigators plan to test the efficacy and safey of 6-months of open-label setmelanotide to treat obesity in a single patient with pseudohypoparathyroidism type 1a due to a GNAS mutation.
A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.
Basic eligibility
AgeNot listed to Not listed
SexAll
Healthy volunteersNot accepted
ConditionPseudohypoparathyroidism Type 1a, Obesity
Full registry criteria
Inclusion Criteria: * Known patient with PHP1a (confirmed GNAS mutation) * Optimized therapy for diabetes and dyslipidemia Exclusion Criteria: \- Use of medications that may affect endpoints that are changed within 3 months prior to Baseline or that are likely to require a change in dose during the open-label treatment period
Treatments and study arms
Setmelanotide
Drug
Setmelanotide will be prescribed at the standard initial dose of 2 mg SC daily. The treatment will be uptitrated at the 2-Week visit to 3 mg SC daily if tolerated. We will continue this maximal dose for a period of 6 months.
Primary outcomes
Greater than or Equal to 5% Weight lossBaseline to 6 Months
Greater than or equal to 5% weight loss from baseline
Study locations
1 locations were listed when this page was built. The first 40 are shown.
Massachusetts General Hospital🇺🇸 Boston, Massachusetts, United States