Actively Recruiting

Phase 2
Age: 18Years - 75Years
All Genders
Healthy Volunteers
NCT06173778

Semaglutide for Post-Smoking Cessation Weight Management

Led by The University of Texas Health Science Center, Houston · Updated on 2026-02-11

197

Participants Needed

2

Research Sites

118 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Semaglutide for Post-Smoking Cessation Weight Management

Who Can Participate

Age: 18Years - 75Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Ability to provide informed consent and comply with study procedures
  • Body mass index (BMI) �30 kg/m2 or �27 kg/m2 with at least one weight-related condition such as hypertension, cardiovascular disease, dyslipidemia, or obstructive sleep apnea
  • Smoking at least 5 cigarettes per day for at least 1 year and positive cotinine test
  • Desire to quit smoking within one month
  • Use of effective contraception if female and of child-bearing potential, or male partner is surgically sterile
  • Negative urine pregnancy test for women of child-bearing potential
  • Normal cognitive restraint with a score less than 4 on the Three Factor Eating Habits Questionnaire
  • No clinically significant contraindications as determined by study physicians
Not Eligible

You will not qualify if you...

  • Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2
  • Acute pancreatitis within the past 6 months
  • History or presence of chronic pancreatitis
  • Type 1 or type 2 diabetes mellitus or HbA1C �38 mmol/mol (6.5%) at screening
  • End stage renal disease or eGFR less than 15 ml/min/1.73 m2
  • Recent major cardiovascular events within 60 days
  • High blood pressure with systolic >159 mmHg or diastolic >99 mmHg
  • History of malignant cancers within 5 years, except certain skin cancers
  • Severe gastrointestinal diseases like gastroparesis
  • Hypersensitivity to nicotine, semaglutide, or related products
  • Pregnancy, lactation, or not using accepted contraception if of childbearing potential
  • Any condition preventing safe study completion as judged by investigators
  • Recent substance abuse except nicotine
  • Positive urine drug test for specific drugs before randomization
  • Psychotic, bipolar, or eating disorders; moderate to high suicidality risk
  • Previous bariatric surgery
  • Weight change of 4.5 kg or more in past 6 months
  • Current enrollment in behavioral weight management
  • Uncontrolled thyroid disease
  • Use of other tobacco products
  • Current use of glucose-lowering or smoking cessation medications
  • Recent use of weight management or appetite-affecting medications
  • Enrollment in conflicting research studies
  • Not planning to live locally for study duration
  • Scheduled surgery during study except minor procedures
  • Inability to communicate fluently in English

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

The University of Texas at Austin

Austin, Texas, United States, 78723

Actively Recruiting

2

The University of Texas Health Science Center at Houston

Houston, Texas, United States, 77054

Actively Recruiting

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Research Team

L

Luba Yammine, PhD

CONTACT

J

Jessica Vincent

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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