Study S000426

Combining Lifestyle Modification and Liraglutide to Improve Weight Loss and Health Outcomes

Name: LivingGLP1 adjudicated trial data and network meta-analysis results
Creator: Ahmad Sofi-Mahmudi
License: https://creativecommons.org/licenses/by/4.0/

ClinicalTrials.gov record Study Protocol and Statistical Analysis Plan (PDF)

Registration

Registration: NCT02911818
Acronym: MODEL
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE4
Masking: NONE
Status: COMPLETED
Enrollment: 150
Start: 2016-09
Primary completion: 2018-11
Lead sponsor: University of Pennsylvania
Conditions: Obesity
Interventions: BEHAVIORAL:CMS-recommended lifestyle counseling; DRUG:Liraglutide 3.0mg; OTHER:Portion-Controlled Diet; DRUG:Placebo Oral Tablet; DRUG:Phentermine 15 MG; BEHAVIORAL:Extension Study CMS-recommended lifestyle counseling
Results posted: TRUE
Individual participant data sharing: NO

Registered primary outcomes

Percent Change in Baseline Weight [Randomization and 52 weeks]
Extension Study Primary Outcome: Percent Change in Re-randomization Weight [Re-randomization and 12 weeks]

Linked records (3)

Automatic links, confirmed or rejected during screening. A record citing this registration may be a secondary analysis, a commentary or a review that mentions the trial.

Record	Title	Year	Design	Identifiers	Link basis
R0024499	Effects of liraglutide on appetite, food preoccupation, and food liking: results of a randomized controlled trial. Tronieri JS, International journal of obesity (2005)	2020	Randomized trial	PMID 30926955 DOI	cites ClinicalTrials.gov:NCT02911818; registry reference DERIVED:30926955
R0024015	Effects of liraglutide plus phentermine in adults with obesity following 1 year of treatment by liraglutide alone: A randomized placebo-controlled pilot trial. Tronieri JS, Metabolism: clinical and experimental	2019	Randomized trial	PMID 30902750 DOI	cites ClinicalTrials.gov:NCT02911818; registry reference DERIVED:30902750
R0024864	Intensive Behavioral Therapy for Obesity Combined with Liraglutide 3.0 mg: A Randomized Controlled Trial. Wadden TA, Obesity (Silver Spring, Md.)	2019	Randomized trial	PMID 30421856 DOI	cites ClinicalTrials.gov:NCT02911818; registry reference DERIVED:30421856