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

NCT02963935 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 282

Last updated 2020-03-11

Study results available
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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

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

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-06
Primary Completion
2018-05-23
Completion
2018-06-19
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02963935 on ClinicalTrials.gov