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

NCT02963935 · Completed

Last updated 2026-05-28

This clinical trial tested whether adding the medication liraglutide (3.0 mg) to intensive lifestyle changes helps adults with obesity lose weight in a real-world healthcare setting.

Status Completed The study has finished.

Phase Phase 3 Confirms effectiveness in a large group before approval.

Type Interventional (clinical trial)

Design Randomized, double-blind treatment study

Participants 282 people

Who can join Ages 18+ · all sexes

Timeline Started 2017-02 · est. completion 2018-06

Where 10 sites · United States

What this study is testing ClinicalTrials.gov NCT02963935 ↗

Description as written by the study sponsor.

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).

Treatments tested

liraglutide Drug

Administered subcutaneously (s.c., under the skin) once daily for 56 weeks. Dose gradually increased to 3.0 mg
placebo Drug

Administered subcutaneously (s.c., under the skin) once daily for 56 weeks. Dose gradually increased to 3.0 mg
CMS Intensive Behavior Therapy Behavioral

Intensive Behaviour Therapy for obesity

Main thing measured	Change in Body Weight (%)
Sponsor	Novo Nordisk A/S
Conditions studied	Metabolism and Nutrition Disorder, Obesity
GLP-1 drugs	liraglutide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT02963935 ↗