Evidence map›Paper›PMID 41145317›Full record

Trial reportObesity (Silver Spring, Md.)2026

Application of the Lancet Commission Criteria for the Diagnosis of Obesity to a Clinical Trials Population: The LEAP Trial.

Faith Anne N Heeren, Kathleen R Ruddiman, Courtney Simmons, Brian N White, Byron C Jaeger, Nicholas M Pajewski, Stephanie A Hooker, Deborah B Horn, Katy Martin-Fernandez, Kimberly A Gudzune and 3 more

Registry-linked trialAbstract readClinical Trial, Phase IVMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Obesity (Silver Spring, Md.), 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05176626 (Long-term Effectiveness of the Antiobesity Medication Phentermine), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing 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.

NCT05176626 phase4active not recruitingnot on this map

Long-term Effectiveness of the Antiobesity Medication Phentermine

TypeinterventionalSponsorWake Forest University Health SciencesRan2022 to 2026Enrolled870ConditionsObesity, Obesity, Drug, Lifestyle, HealthyArmsOnline Lifestyle Behavioral Therapy, Phentermine Hydrochloride 8 MG
3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Trial
  2. Review
  3. Article
  4. Article
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

13 authors.

Faith Anne N HeerenDepartment of Implementation Science, Wake Forest University School of Medicine, Winston-Salem, North Carolina, USA.ORCID https://orcid.org/0000-0002-6819-8258
Kathleen R RuddimanDepartment of Internal Medicine, Endocrinology Section, Wake Forest University School of Medicine, Winston-Salem, North Carolina, USA.ORCID https://orcid.org/0009-0005-5721-1874
Courtney SimmonsDepartment of Biostatistics and Data Science, Wake Forest University School of Medicine, Winston-Salem, North Carolina, USA.ORCID https://orcid.org/0000-0002-3613-2377
Brian N WhiteDepartment of Biostatistics and Data Science, Wake Forest University School of Medicine, Winston-Salem, North Carolina, USA.
Byron C JaegerDepartment of Biostatistics and Data Science, Wake Forest University School of Medicine, Winston-Salem, North Carolina, USA.
Nicholas M PajewskiDepartment of Biostatistics and Data Science, Wake Forest University School of Medicine, Winston-Salem, North Carolina, USA.
Stephanie A HookerHealthPartners Institute, Minneapolis, Minnesota, USA.ORCID https://orcid.org/0000-0003-4222-7046
Deborah B HornDepartment of Surgery, University of Texas McGovern Medical School, Houston, Texas, USA.
Katy Martin-FernandezAtrium Health Wake Forest Baptist, Weight Management Center, Winston-Salem, North Carolina, USA.
Kimberly A GudzuneAmerican Board of Obesity Medicine Foundation, Denver, Colorado, USA.ORCID https://orcid.org/0000-0002-7782-1769
Caroline Blackwell YoungDepartment of Epidemiology and Prevention, Wake Forest University School of Medicine, Winston-Salem, North Carolina, USA.
Jamy ArdDepartment of Internal Medicine, Endocrinology Section, Wake Forest University School of Medicine, Winston-Salem, North Carolina, USA.
Kristina Henderson LewisDepartment of Implementation Science, Wake Forest University School of Medicine, Winston-Salem, North Carolina, USA.ORCID https://orcid.org/0000-0002-4921-7230

Funding

The Vanderbilt Institute for Clinical and Translational Research (VICTR)UL1TR000445 · NCATS · VANDERBILT UNIVERSITY MEDICAL CENTER · PI BERNARD, GORDON RAPHAEL · 2012 to 2016
$41.4M
Center for Clinical and Translational SciencesUM1TR004906 · NCATS · UNIVERSITY OF TEXAS HLTH SCI CTR HOUSTON · PI Maria Eulalia Fernandez, LORNA H. MCNEILL · 2024 to 2026
$16.7M
CTSA UM1 Program at Wake ForestUM1TR004929 · NCATS · WAKE FOREST UNIVERSITY HEALTH SCIENCES · PI Jamy D Ard, KRISTIE L FOLEY · 2024 to 2026
$11.9M
1/2, Clinical Coordinating Center for the Long-term Effectiveness of the Anti-obesity medication Phentermine: the LEAP TrialUH3HL155801 · NHLBI · WAKE FOREST UNIVERSITY HEALTH SCIENCES · PI ARD, JAMY D, LEWIS, KRISTINA H · 2022 to 2025
$6.7M
Cancer Prevention And Control Training Grant (CAPACITY)T32CA122061 · NCI · WAKE FOREST UNIVERSITY HEALTH SCIENCES · PI KRISTIE L FOLEY, Kathryn Elizabeth Weaver · 2019 to 2026
$2.1M
2/2, Data Coordinating Center for the Long-term Effectiveness of the Anti-obesity medication Phentermine: the LEAP TrialU24HL155802 · NHLBI · WAKE FOREST UNIVERSITY HEALTH SCIENCES · PI PAJEWSKI, NICHOLAS M. · 2021 to 2025
$1.9M
NCATS NIH HHS UL1 TR000445NCATS NIH HHS UM1 TR004906NCATS NIH HHS UM1 TR004929NCI NIH HHS T32 CA122061NHLBI NIH HHS U24 HL155802NHLBI NIH HHS U24HL155802NHLBI NIH HHS UH3 HL155801NHLBI NIH HHS UH3HL155801
6 · The paper itself

Abstract

objectiveThis study aimed to apply The Lancet Diabetes & Endocrinology criteria for diagnosing obesity among clinical trial participants and understand participants' characteristics by obesity status.

methodsThe criteria were operationalized and applied to baseline data from the Long-term Effectiveness of the Anti-obesity medication Phentermine (LEAP) trial (NCT05176626). Excess adiposity, organ and tissue dysfunction, and limitations to daily activities were assessed. We examined differences between participants with "no obesity," "pre-clinical obesity," and "clinical obesity."

resultsAmong the 860 participants, 0.8% had no obesity (mean BMI 29.0 kg/m

conclusionsAmong clinical trial participants eligible for obesity pharmacotherapy, 19.5% were classified as having no/pre-clinical obesity using the Lancet criteria. Applying the criteria was complicated in a well-resourced trial setting, which suggests potential challenges in implementing these guidelines in real-world practice.

Indexed as

ObesityAdiposityAdultAgedAnti-Obesity AgentsBody Mass IndexFemaleHumansMaleMiddle AgedPhentermineAnti-Obesity AgentsPhentermineclinical carediagnosisobesity medicationobesity treatmentpharmacotherapy

Identifiers

PMID41145317
PMCPMC12724050

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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 OpenQuestion graph.