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Trial · Interventional

CompletedPhase 3Results postedRegistry data

Individualized Obesity Pharmacotherapy

NCTNCT03374956 (opens ClinicalTrials.gov in a new tab)Other id17-003449
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
193 participants (actual)
Sponsor
Mayo Clinic · Other
Design
Randomized · Triple masking
Countries
1 country

United States

Start
11 Dec 2017
Primary completion
26 May 2022
Completion
26 May 2022
First posted
15 Dec 2017
Last update posted
18 Jul 2023
Conditions
Obesity

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2017201820192020202120222023
  1. Ph 3

    Individualized Obesity Pharmacotherapy

    NCT03374956

    11 Dec 2017 to 26 May 2022

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The researchers are trying to identify the specific characteristics (phenotypes) that may be useful to help select the right medication for weight loss.

Interventions

  • Phentermine-TopiramateDrug
  • LiraglutideDrug
  • Naltrexone/bupropionDrug
  • PhentermineDrug

Arms2

  • Experimental

    Intervention group

    Phenotype-guided pharmacotherapy, which includes Phentermine-Topiramate, Liraglutide, Naltrexone/bupropion or Phentermine plus Exercise

  • Active comparator

    Control Group

    Randomly assigned pharmacotherapy, which includes Phentermine-Topiramate, Liraglutide, Naltrexone/bupropion or Phentermine

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change in Total Body Weight

    Time frame · baseline to 12 weeks

    Registry description

    Percent change in body weight

Secondary outcomes(2)

  1. Percentage of Responders

    Time frame · baseline to 12 weeks

    Registry description

    Percentage of participants who loss 5% or more of total body weight

  2. Percentage of Responders

    Time frame · baseline to 12 weeks

    Registry description

    Percentage of participants with at least 10% total body weight loss

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMedian· baseline to 12 weeks

Change in Total Body Weight

GroupValue (percent change)
Intervention Group-7.7
Control Group-6.5
Secondary and other outcome results(2)
Secondary outcomeNumber· baseline to 12 weeks

Percentage of Responders

GroupValue (percentage of participants)
Intervention Group81
Control Group80
Secondary outcomeNumber· baseline to 12 weeks

Percentage of Responders

GroupValue (percentage of participants)
Intervention Group44
Control Group40

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Intervention GroupPhenotype-guided pharmacotherapy, which includes Phentermine-Topiramate, Liraglutide, Naltrexone/bupropion or Phentermine plus Exercise Phentermine-Topiramate: Extended Release at dose of 7.5/46 mg oral daily Liraglutide: dose of 3 mg subcutaneous daily Naltrexone/bupropion: Oral naltrexone extended-release/bupropion extended-release at dose of 32/360 mg oral daily (divided in 2 tables in morning and 2 tablets in evening)0 / 930 / 9323 / 93
Control GroupRandomly assigned pharmacotherapy, which includes Phentermine-Topiramate, Liraglutide, Naltrexone/bupropion or Phentermine Phentermine-Topiramate: Extended Release at dose of 7.5/46 mg oral daily Liraglutide: dose of 3 mg subcutaneous daily Naltrexone/bupropion: Oral naltrexone extended-release/bupropion extended-release at dose of 32/360 mg oral daily (divided in 2 tables in morning and 2 tablets in evening) Phentermine: 15-37.5 mg oral daily0 / 1000 / 10025 / 100

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

More studies

1 study on this page

PubMed tag: none · 2021

Corrected

Selection of Antiobesity Medications Based on Phenotypes Enhances Weight Loss: A Pragmatic Trial in an Obesity Clinic.

Acosta et al. 2021Obesity (Silver Spring, Md.)cited by 173

PMID 33759389PMC8168710DOI 10.1002/oby.23120PUB-33759389

Free to read · publisher termsCC BY-NC-ND
Read at sourceRead the notice

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 75 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion criteria: * Adults with obesity (BMI \>30 Kg/m2); these will be otherwise healthy individuals with no unstable psychiatric disease and controlled comorbidities or other diseases. * Gender: Men or women. Women of childbearing potential will have negative pregnancy tests within 48 hours of enrollment and before each radiation exposure. Exclusion criteria * Abdominal bariatric surgery * Positive history of chronic gastrointestinal diseases, or systemic disease that could affect gastrointestinal motility, or use of medications that may alter gastrointestinal motility, appetite or absorption, e.g., orlistat, within the last 6 months. * Significant untreated psychiatric dysfunction based upon screening with the Hospital Anxiety and Depression Inventory (HAD), and the Questionnaire on Eating and Weight Patterns (binge eating disorders and bulimia). If such a dysfunction is identified by an anxiety or depression score \>11 or difficulties with substance or eating disorders, the participant will be excluded and given a referral letter to his/her primary care doctor for further appraisal and follow-up. * Hypersensitivity to any of the study medications. * No contraindications to all FDA-approved medications

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