Evidence map›Paper›PMID 40518455›Full record

Trial reportInternational journal of obesity (2005)2025

Predictors of BMI reduction with phentermine/topiramate in adolescents with obesity.

Megan O Bensignor, Rebecca L Freese, Kyle D Rudser, Aaron S Kelly, Alicia Kunin-Batson, Amy C Gross, Carolyn Bramante, Winnie Shih, Craig Peterson, Claudia K Fox

Abstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in International journal of obesity (2005), 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. Review
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.

Megan O BensignorDepartment of Pediatrics, Medical School, University of Minnesota, Minneapolis, MN, USA. moberle@umn.edu.ORCID 0000-0002-9341-1858
Rebecca L FreeseClinical and Translational Science Institute, Biostatistical Design and Analysis Center, University of Minnesota, Minneapolis, MN, USA.
Kyle D RudserClinical and Translational Science Institute, Biostatistical Design and Analysis Center, University of Minnesota, Minneapolis, MN, USA.
Aaron S KellyDepartment of Pediatrics, Medical School, University of Minnesota, Minneapolis, MN, USA.
Alicia Kunin-BatsonDepartment of Pediatrics, Medical School, University of Minnesota, Minneapolis, MN, USA.
Amy C GrossDepartment of Pediatrics, Medical School, University of Minnesota, Minneapolis, MN, USA.ORCID 0000-0003-2809-8460
Carolyn BramanteCenter for Pediatric Obesity Medicine, University of Minnesota Medical School, Minneapolis, MN, USA.ORCID 0000-0001-5858-2080
Winnie ShihVIVUS LLC, Campbell, CA, USA.
Craig PetersonVIVUS LLC, Campbell, CA, USA.
Claudia K FoxDepartment of Pediatrics, Medical School, University of Minnesota, Minneapolis, MN, USA.ORCID 0000-0001-5732-0062

Funding

University of Minnesota Clinical and Translational Science Institute (UMN CTSI)UM1TR004405 · NCATS · UNIVERSITY OF MINNESOTA · PI Bruce R Blazar, Damien A Fair · 2023 to 2026
$30.8M
Anti-obesity pharmacotherapy to decrease BMI and improve insulin sensitivity in adolescents with obesity and type 2 diabetesK23DK129721 · NIDDK · UNIVERSITY OF MINNESOTA · PI BENSIGNOR, MEGAN O · 2021 to 2025
$1.0M
NCATS NIH HHS UM1 TR004405NIDDK NIH HHS K23 DK129721
6 · The paper itself

Abstract

BACKGROUND/

objectivesObesity treatment can produce variable outcomes for different individuals. The aim of this analysis in adolescents with obesity was to investigate if baseline participant characteristics associated with BMI reduction from baseline to 56 weeks when treated with mid- or top-dose phentermine/topiramate (PHEN/TPM) compared to placebo.

methodsA secondary analysis of a randomized, double-blind, placebo-controlled, clinical trial evaluating PHEN/TPM in adolescents with obesity was conducted. Participants, aged 12 to <17 years with a BMI ≥95th percentile, were randomly assigned in a 1:1:2 ratio to receive either placebo, mid-dose (PHEN/TPM 7.5 mg/46 mg) or top-dose (PHEN/TPM 15 mg/92 mg). Baseline characteristics included in the analysis were BMI, age, sex, race/ethnicity, pubertal status, diabetes status, depression status, cognitive function score, and quality of life score. The primary analysis used linear regression with BMI percent change from baseline to 56 weeks as the outcome with either mid- or top-dose PHEN/TPM compared to placebo.

resultsTwo-hundred twenty-two participants were included in the final analysis. None of the baseline characteristics were statistically significantly associated with BMI reduction with mid- or top-dose PHEN/TPM compared to placebo.

conclusionsBaseline characteristics were not predictive of BMI reduction with either dose of PHEN/TPM compared to placebo in adolescents with obesity.

Indexed as

Anti-Obesity AgentsPediatric ObesityPhentermineTopiramateWeight LossAdolescentBody Mass IndexChildDouble-Blind MethodFemaleHumansMaleSecondary Data AnalysisTreatment OutcomeAnti-Obesity AgentsPhentermineTopiramate

Identifiers

PMID40518455
PMCPMC12463650

What Socratic holds

Textmetadata
LicenceCC BY
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Registered trials

None linked

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.