Study S000712

Effect and Safety of Liraglutide 3.0 mg as an Adjunct to Intensive Behaviour Therapy for Obesity in a Non-specialist Setting

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

Included trial: extracted data ClinicalTrials.gov record Study Protocol (PDF)Statistical Analysis Plan (PDF)

Registration

Registration: NCT02963935
Acronym: SCALE™ IBT
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE3
Masking: DOUBLE
Status: COMPLETED
Enrollment: 282
Start: 2017-02-06
Primary completion: 2018-05-23
Lead sponsor: Novo Nordisk A/S
Conditions: Metabolism and Nutrition Disorder; Obesity
Interventions: DRUG:liraglutide; DRUG:placebo; BEHAVIORAL:CMS Intensive Behavior Therapy
Results posted: TRUE
Individual participant data sharing: YES
Secondary identifiers: OTHER:U1111-1177-5059

Registered primary outcomes

Change in Body Weight (%) [Week 0, week 56]
Proportion of Subjects Losing at Least 5% of Baseline Body Weight at Week 56 [Week 56]

Linked records (5)

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
R0024012	Liraglutide 3.0 mg and Intensive Behavioral Therapy (IBT) for Obesity in Primary Care: The SCALE IBT Randomized Controlled Trial. Wadden TA, Obesity (Silver Spring, Md.)	2020	Randomized trial	PMID 32090517 DOI	registry reference RESULT:32090517
R0024896	SAT-099 Liraglutide 3.0 mg as an Adjunct to Intensive Behavior Therapy in Individuals with Obesity: SCALE IBT 56-Week Randomized, Double-Blind, Placebo-Controlled Trial Wadden T, Journal of the Endocrine Society	2019	Randomized trial	DOI	cites ClinicalTrials.gov:NCT02963935
R0024974	MON-120 Effect of Weight Loss on Physical Function Measured by the 6-Minute Walking Distance Test in Individuals with Obesity: Results from the SCALE IBT Trial of Liraglutide 3.0 Mg Rubino D, Journal of the Endocrine Society	2019	Randomized trial	DOI	cites ClinicalTrials.gov:NCT02963935
R0048875	SAT-105 Weight Loss As Determined By Adherence To Reduced Caloric Diet, Increased Physical Activity, Liraglutide 3.0 Mg and Placebo: A Sub-analysis Of The SCALE IBT Trial Jena Shaw Tronieri, Journal of the Endocrine Society	2019	Randomized trial	DOI	cites ClinicalTrials.gov:NCT02963935
R0051746	SAT-097 Weight Loss With Liraglutide 3.0 Mg Versus Placebo For Individuals Who Adhere To The Trial Drug: A Secondary Analysis From SCALE IBT Jena Shaw Tronieri, Journal of the Endocrine Society	2019	Randomized trial	DOI	cites ClinicalTrials.gov:NCT02963935