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Quality of life improvements with setmelanotide treatment in acquired hypothalamic obesity: TRANSCEND trial interview results from US participants
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DOI：10.3389/fnbeh.2026.1830070.png)
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Abstract
En 中文
IntroductionAcquired 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.MethodsIn-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/).ResultsOf the 30 interview participants; 14 were trial participants (4 adolescents and 10 adults) and 16 were caregivers of participants aged < 12 years (n = 8) and ≥ 12 years (n = 8); 23 received setmelanotide and 7 received placebo. All interview participants reported insatiable hunger and accelerated and sustained weight gain after hypothalamic injury but before starting the trial; 29 of 30 interview participants reported reduced energy level. Consistently; trial participants who received setmelanotide and their caregivers reported beneficial changes in hunger; weight; energy level; and physical activity; and indicated these changes were meaningful; while in placebo-treated participants; no such changes were observed.ConclusionThese 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 registrationClinicalTrials.gov; identifier NCT05774756.
Keywords:
quality of life
hyperphagia
setmelanotide
acquired hypothalamic obesity
TRANSCEND trial
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