Evidence mapPaperPMID 42528856Full record

Trial reportFrontiers in behavioral neuroscience2026

Quality of life improvements with setmelanotide treatment in acquired hypothalamic obesity: TRANSCEND trial interview results from US participants.

Christian L Roth, Susan A Phillips, Shana E McCormack, Katie Larson Ode, Megan M Kelsey, Jieruo Liu, Claire Ervin, Usha G Mallya, Lindsey Norcross, Jennifer L Miller

Registry-linked trialAbstract readClinical Trial
In one paragraph

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.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05774756 phase3active not recruitingnot on this map

A Phase 3, Double Blind, Randomized, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Setmelanotide in Patients With Acquired Hypothalamic Obesity

TypeinterventionalSponsorRhythm Pharmaceuticals, Inc.Ran2023 to 2027Enrolled143ConditionsHypothalamic ObesityArmsSetmelanotide, Placebo
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors.

Christian L RothSeattle Children's Research Institute, Seattle, WA, United States.
Susan A PhillipsRady Children's Hospital, University of California, San Diego, San Diego, CA, United States.
Shana E McCormackDivision of Endocrinology and Diabetes, Children's Hospital of Philadelphia, Philadelphia, PA, United States.
Katie Larson OdeDepartment of Pediatrics, University of Iowa-Stead Family Children's Hospital, Fraternal Order of Eagles Diabetes Research Center, University of Iowa, Iowa City, IA, United States.
Megan M KelseyDepartment of Pediatrics, University of Colorado School of Medicine and Children's Hospital Colorado, Aurora, CO, United States.
Jieruo LiuRhythm Pharmaceuticals, Inc., Boston, MA, United States.
Claire ErvinRTI Health Solutions, Durham, NC, United States.
Usha G MallyaRhythm Pharmaceuticals, Inc., Boston, MA, United States.
Lindsey NorcrossRTI Health Solutions, Durham, NC, United States.
Jennifer L MillerPediatric Endocrinology, Department of Pediatrics, College of Medicine, University of Florida, Gainesville, FL, United States.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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.

Indexed as

acquired hypothalamic obesityhyperphagiaquality of lifesetmelanotideTRANSCEND trial

Identifiers

PMID42528856
PMCPMC13415934

What Socratic holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.