Semaglutide for Post-Smoking Cessation Weight Management

Part of paid clinical trials in Austin, Texas.

Sponsor
The University of Texas Health Science Center, Houston
Study ID
NCT06173778
Phase
PHASE2
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Accepted

Interventions

  • semaglutide 2.4mg — DRUG
    Semaglutide 2.4mg will be self-administered once a week under the surface of the skin and will be started at 0.24mg once a week for 4 weeks; in 4-week intervals, the dose will be increased until a dose of 2.4mg is reached
  • Placebo — DRUG
    Non-active medication, self-administered
  • Nicotine Replacement Therapy (NRT, nicotine patch) — DRUG
    Participants who smoke \>10 cigarettes/day will use 21 mg patches for the first 6 weeks, 14 mg patches during weeks 7 and 8, and 7 mg patches during weeks 9 and 10. Participants who smoke 5-10 cigarettes per day will use 14 mg patches for the first 6 weeks and 7 mg patches for weeks 7-10.
  • Brief Smoking Cessation Counseling — BEHAVIORAL
    Participants will receive weekly, manual-based individual smoking cessation counseling. Counseling will be provided by master's level clinicians.

Study Details

This trial will examine the effect of semaglutide 2.4mg on changes in body weight, body composition, and peripheral and central mechanisms that control appetite, satiety, and food intake in the context of smoking cessation.

Key Dates

Start date
Apr 23, 2024
Status verified
Feb 2026
Primary completion
Jul 1, 2026
Completion
Aug 1, 2026

Study Design

Enrollment
197 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: semaglutide
  • Placebo Comparator: placebo

Primary Outcome Measure

Change in Body Weight Percent [ Time Frame: Baseline to Week 28 ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
The University of Texas at AustinAustinTexas78723
Heather Leidy, PhD
573-825-2620
Connor Roenfeldt
314-704-3842
Heather Leidy, PhD (PRINCIPAL_INVESTIGATOR)
The University of Texas Health Science Center at HoustonHoustonTexas77054
Luba Yammine, PhD
713-486-2737
Jessica Vincent
713-486-2803
Luba Yammine, PhD (PRINCIPAL_INVESTIGATOR)

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