Exenatide, NRT, and Smoking Cessation Counseling for Weight Gain

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Weight Gain+2 More
Exenatide 2 milligram (mg) Injection - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

The purpose of this study is to determine if exenatide improves end-of-treatment smoking abstinence rates and to determine if exenatide mitigates post-cessation weight gain.

Eligible Conditions
  • Smoking, Cessation
  • Weight Gain

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Weight Gain

Study Objectives

2 Primary · 3 Secondary · Reporting Duration: Week 26

Baseline, Week 15
Weight change in kilograms at 12 weeks post-target quit day
Baseline, Week 26
Weight change in kilograms at 24 weeks post-target quit day
Week 1, Week 3
Change in amplitude of the late positive potential evoked by visual stimuli
Week 15
Percentage of participants with 4-week continuous abstinence at 12 weeks post-target quit day as assessed by self-report timeline followback (TLFB) and verified by breath carbon monoxide (CO) level
Week 26
Percentage of participants with 4-week continuous abstinence at 24 weeks post-target quit day as assessed by self-report timeline followback (TLFB) and verified by breath carbon monoxide (CO) level

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Weight Gain

Trial Design

2 Treatment Groups

Exenatide, NRT, and Smoking Cessation Counseling
1 of 2
Placebo, NRT, and Smoking Cessation Counseling
1 of 2
Active Control
Non-Treatment Group

216 Total Participants · 2 Treatment Groups

Primary Treatment: Exenatide, NRT, and Smoking Cessation Counseling · Has Placebo Group · Phase 2

Exenatide, NRT, and Smoking Cessation CounselingActiveComparator Group · 3 Interventions: Exenatide 2 milligram (mg) Injection, Nicotine patch, Smoking Cessation Counseling · Intervention Types: Drug, Drug, Behavioral
Placebo, NRT, and Smoking Cessation CounselingPlaceboComparator Group · 3 Interventions: Nicotine patch, Smoking Cessation Counseling, Placebo · Intervention Types: Drug, Behavioral, Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: week 26

Who is running the clinical trial?

The University of Texas Health Science Center, HoustonLead Sponsor
799 Previous Clinical Trials
249,843 Total Patients Enrolled
Luba Yammine, PhDPrincipal InvestigatorThe University of Texas Health Science Center, Houston
2 Previous Clinical Trials
87 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are male or female, 18-75 years of age.
You have a desire to quit smoking.
You have a HbA1C level between 5.7 and 6.
You are a woman of child-bearing potential who has not had a pregnancy within the past 12 months.
You are willing and able to sign and date an informed consent form, willing to comply with all study procedures, and be available for the duration of the study.
You have hematology and chemistry laboratory tests that are within reference limits (±10%), with the following exception: pancreatic tests (lipase and amylase) must be within normal limits.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 29th, 2021

Last Reviewed: October 15th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

Who else is applying?

What state do they live in?
Texas100.0%
How old are they?
18 - 65100.0%
What site did they apply to?
The University of Texas Health Science Center at Houston100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%
How many prior treatments have patients received?
0100.0%