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GLP-1 Receptor Agonist
Semaglutide for Weight Management After Quitting Smoking
Phase 2
Recruiting
Led By Luba Yammine, PhD
Research Sponsored by The University of Texas Health Science Center, Houston
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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, cardiovascular disease, dyslipidemia, or obstructive sleep apnea
Be older than 18 years old
Must not have
Personal or first-degree relative(s) history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN 2).
History or presence of chronic pancreatitis.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Summary
This trial will explore how a drug can help people lose weight and quit smoking.
Who is the study for?
This trial is for adults who smoke more than 5 cigarettes a day, want to quit smoking within a month, and are overweight or obese. They must be willing to follow the study procedures and use contraception if applicable. People with diabetes, severe kidney disease, recent heart issues, uncontrolled blood pressure, certain cancers in the last 5 years, or gastrointestinal diseases cannot join.
What is being tested?
The trial tests whether semaglutide can help manage weight gain after quitting smoking. Participants will receive either semaglutide or a placebo alongside nicotine patches and brief counseling for smoking cessation to see how it affects their weight and appetite control.
What are the potential side effects?
Semaglutide may cause digestive problems like nausea or diarrhea, potential inflammation of the pancreas (pancreatitis), allergic reactions at injection sites, changes in blood sugar levels even without diabetes history; nicotine patches might cause skin irritation or sleep disturbances.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My BMI is over 30, or it's over 27 with a condition like high blood pressure, heart disease, high cholesterol, or sleep apnea.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I or my close family have a history of MTC or MEN 2.
Select...
I have a history of or currently have chronic pancreatitis.
Select...
I have a severe stomach condition that slows digestion.
Select...
I do not have a diagnosed psychotic, bipolar, or severe mood disorder, nor an eating disorder.
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I use tobacco products like cigars, chewing tobacco, or e-cigarettes.
Select...
My kidneys are in the final stage of chronic kidney disease.
Select...
I have not had a heart attack, stroke, or severe chest pain in the last 60 days.
Select...
I have diabetes, confirmed by a high HbA1C level.
Select...
I am allergic to nicotine products or semaglutide.
Select...
I am not pregnant, planning to become pregnant, breastfeeding, or if capable of becoming pregnant, I am using contraception.
Select...
I have had weight loss surgery in the past.
Select...
I am currently taking medication to lower my blood sugar.
Select...
I am currently using medication to help me stop smoking.
Select...
I have taken medication that affects my appetite or weight in the last 14 days.
Select...
I can communicate fluently in English.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: semaglutideExperimental Treatment3 Interventions
Group II: placeboPlacebo Group3 Interventions
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Who is running the clinical trial?
The University of Texas Health Science Center, HoustonLead Sponsor
946 Previous Clinical Trials
344,388 Total Patients Enrolled
28 Trials studying Obesity
15,103 Patients Enrolled for Obesity
Luba Yammine, PhDPrincipal InvestigatorThe University of Texas Health Science Center, Houston
3 Previous Clinical Trials
303 Total Patients Enrolled
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