NCT02963935

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 282 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Metabolism and Nutrition Disorder
• Obesity

Interventions

Type	Name	Description
DRUG	liraglutide	Administered subcutaneously (s.c., under the skin) once daily for 56 weeks. Dose gradually increased to 3.0 mg
DRUG	placebo	Administered subcutaneously (s.c., under the skin) once daily for 56 weeks. Dose gradually increased to 3.0 mg
BEHAVIORAL	CMS Intensive Behavior Therapy	Intensive Behaviour Therapy for obesity

Timeline

• Start date: 2017-02-06
• Primary completion: 2018-05-23
• Completion: 2018-06-19
• First posted: 2016-11-15
• Last updated: 2020-03-11
• Results posted: 2019-07-30

Locations

10 sites across 1 country: United States

Regulatory

• FDA-regulated drug study