Trial reportFrontiers in behavioral neuroscience2026
Quality of life improvements with setmelanotide treatment in acquired hypothalamic obesity: TRANSCEND trial interview results from US participants.
Trial report in Frontiers in behavioral neuroscience, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05774756 (A Phase 3, Double Blind, Randomized, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Setmelanotide in Patients With Acquired Hypothalamic Obesity), which is not on this map. Not yet cited in PubMed.
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A Phase 3, Double Blind, Randomized, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Setmelanotide in Patients With Acquired Hypothalamic Obesity
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10 authors.
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Abstract
Introduction: Acquired hypothalamic obesity (HO), caused by hypothalamic injury, is characterized by hyperphagia (i.e., insatiable hunger and abnormal food-seeking behaviors), reduced energy expenditure, and accelerated and sustained weight gain, all of which substantially impact quality of life. In the Phase 3, randomized, double-blind, placebo-controlled TRANSCEND trial (ClinicalTrials.gov identifier: NCT05774756), setmelanotide demonstrated significant improvements compared with placebo in body mass index, hunger, symptoms of hyperphagia, and quality of life in participants with acquired HO. This substudy further characterizes changes in hunger, weight, energy level, and physical activity with setmelanotide and assesses the perceived meaningfulness of such benefits to patients and their caregivers. Methods: In-depth, 75-min qualitative interviews were conducted from July 2024 to January 2025 with eligible and consented English-speaking TRANSCEND trial participants or their caregivers in the United States. Interviews followed a semistructured interview guide tailored to facilitate discussion about participant experiences or caregiver observations regarding changes in weight, hunger, and energy level before and during trial participation. Interview participants were also asked to describe the perceived meaningfulness of any changes experienced. Interviews were audio recorded and transcribed; thematic analysis was conducted using ATLAS.ti (https://atlasti.com/). Results: Of the 30 interview participants, 14 were trial participants (4 adolescents and 10 adults) and 16 were caregivers of participants aged < 12 years ( Conclusion: These findings support the Phase 3 TRANSCEND efficacy outcomes pertaining to weight, hunger, energy levels, and quality of life and that the impactful changes with setmelanotide in patients with acquired HO and their caregivers extend beyond body mass index and weight reduction. Clinical trial registration: ClinicalTrials.gov, identifier NCT05774756.
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