Health TrialsbyHealthPanel

Semaglutide for Post-Smoking Cessation Weight Management

ConditionsObesityOverweightCigarette Smoking
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorThe University of Texas Health Science Center, Houston

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Ability to provide informed consent before any study-related activity, willing to comply with al study procedures, and be available for the duration of the study.

Body mass index (BMI) ≥30 kg/m2 or ≥27 kg/m2 with the presence of at least one of the following weight-related comorbidities (treated or untreated): hypertension (unless meets medical exclusion criterion 7), cardiovascular disease (unless meets medical exclusion criterion 6), dyslipidemia, or obstructive sleep apnea

Have been smoking ≥5 cigarettes per day for at least 1 year (prior to screening) and provide positive cotinine test.

Desire to quit smoking (defined as "intend to quit within one month")

Disqualifiers

Personal or first-degree relative(s) history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN 2).

Acute pancreatitis within the past 6 months prior to screening.

History or presence of chronic pancreatitis.

Type 1 or type 2 Diabetes Mellitus (previously diagnosed or indicated by HbA1C ≥48 mmol/mol (6.5%) as measured by central laboratory at screening).

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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 or 0.25mg 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.

Treatment groups

197 Participants
are divided into 2 treatment groups
Group A: semaglutideExperimental treatment 3 interventions
Group B: placeboPlacebo comparator 3 interventions

Trial outcomes

Primary outcomes

1

Change in Body Weight Percent

Time frame
Baseline to Week 28

Secondary outcomes

1

Change in body weight as measured in kilograms (kg)

Time frame
Baseline to Week 28
2

Change in body fat mass as measured in kilograms (kg)

Time frame
Baseline to Week 28
3

Change in waist circumference as measured in centimeters(cm)

Time frame
Baseline to Week 28

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The University of Texas Health Science Center, Houston

Lead sponsor

Source ClinicalTrials.gov
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