CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 40 enrolled
Drug / intervention
Liraglutide +2 moredrug
Likely dose
Liraglutide 3.0 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03712098
NCT03712098Phase 2Completed

Glucagon-like Peptide-1 Receptor Agonists as Novel Pharmacotherapies for Nicotine Dependence

Rebecca Ashare·interventional·Posted Oct 19, 2018·Updated Sep 21, 2023

In Brief

A Phase 2 clinical trial evaluating Liraglutide, Placebo, and 1 other intervention for Smoking Cessation and Weight, Body. Completed, enrolled 40 participants across 1 site.

Detailed Summary

This clinical research trial examines the effects of the GLP-1 receptor agonist liraglutide on smoking behavior, food intake, and weight gain. In this double-blind, placebo-controlled, parallel arm pilot study, overweight and obese smokers (N=40; 20 female and 20 male) will be randomized to 32 weeks of liraglutide or placebo and undergo 8 sessions of smoking cessation behavioral counseling. Outcomes are smoking abstinence and weight change.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsNovo Nordisk A/S

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedOct 19, 2018
Enrollment StartNov 29, 2018
Primary CompletionMay 25, 2022
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 7.7 years ago

Interventions

Liraglutidedrug

Liraglutide 3.0 mg is an injectable medicine that may help some adults with excess weight (BMI ≥27) who also have weight-related medical problems or obesity (BMI ≥30) lose weight and keep the weight off. Liraglutide is approved by the U.S. Food and Drug Administration (FDA) for chronic weight management when combined with a reduced-calorie meal plan and physical activity.

Placebodrug

The placebo is an inactive substance that is designed to look like liraglutide but contains no medication.

Smoking Cessation Counselingbehavioral

All participants receive manual-based counseling from a trained smoking cessation counselor. The counseling sessions are designed to enhance awareness of the harmful effects of smoking, assist the participant in developing skills to quit, and avoid relapse.