drugset / Trial / NCT02963935

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

NCT02963935 ↗

Phase 3 Completed 282 enrolled Novo Nordisk A/S
RandomizedParallel-groupDouble-blindTreatment

Summary

This trial is conducted in the United States of America (USA). The purpose of the trial is to investigate the effect and safety of liraglutide 3.0 mg as an adjunct to intensive behaviour therapy for obesity in a non-specialist setting (IBT-CMS: Intensive Behaviour Therapy for obesity in a primary care setting according to Centers for Medicare \& Medicaid Services (CMS) visit schedule).

Timeline

Start
2017-02-06
Primary completion
2018-05-23
Completion
2018-06-19

Outcome

Met primary endpoint

registry analysis (superiority test); Liraglutide 3.0 mg vs Placebo; p = 0.0003; Treatment difference -3.45 (95% CI -5.31 to -1.59); ANCOVA NCT02963935 ↗

registry analysis (superiority test); Liraglutide 3.0 mg vs Placebo; p = 0.0003; Odds Ratio (OR) 2.51 (95% CI 1.53 to 4.14); Regression, Logistic NCT02963935 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Liraglutide Peptide 3 mg Subcutaneous