Semaglutide for Weight Management After Quitting Smoking

Recruiting at 1 trial location

Overseen By Heather Leidy, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: The University of Texas Health Science Center, Houston

Must not be taking: Glucose-lowering, Smoking cessation, Weight management, Corticosteroids

Disqualifiers: Diabetes, Renal disease, Substance abuse, others

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

197 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests semaglutide, a medication, to determine its effectiveness in helping people manage weight after quitting smoking. Researchers aim to understand how semaglutide affects body weight, appetite, and food intake. Participants will receive either semaglutide or a placebo, a harmless pill with no active ingredient, to compare results. Ideal candidates have smoked at least 5 cigarettes a day for a year, wish to quit smoking soon, and face challenges in managing their weight. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

You may need to stop taking certain medications before joining the trial. Specifically, you cannot be using medications for smoking cessation, glucose-lowering medications, or weight management drugs. Additionally, you should not have taken medications affecting appetite or weight in the last 14 days before screening.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that semaglutide, the treatment under study, is generally well-tolerated. One study on semaglutide for weight management found no serious safety issues. Participants in that study took a dose of 2.4 mg once a week, the same dosage used in this trial.

Some minor side effects, such as nausea and vomiting, were reported but were usually temporary and manageable. Importantly, the FDA has already approved semaglutide for treating type 2 diabetes and weight management, indicating it has passed strict safety checks for those uses.

Overall, evidence suggests semaglutide is safe, but individual experiences can vary. Participants should discuss any concerns with their healthcare provider before joining a trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Semaglutide is unique because it is a GLP-1 receptor agonist, which means it mimics a hormone that helps regulate appetite and food intake. This is different from most weight management treatments that often focus on reducing fat absorption or increasing metabolism. Researchers are excited about semaglutide because it not only helps control weight but may also support people who have recently quit smoking by reducing weight gain, a common challenge after quitting. Additionally, semaglutide has shown promise in managing other metabolic conditions, making it a versatile option compared to standard treatments.

What evidence suggests that semaglutide might be an effective treatment for weight management after quitting smoking?

Research has shown that semaglutide, which participants in this trial may receive, can aid in weight loss, particularly for those attempting to quit smoking. One study found that taking 2.4 mg of semaglutide weekly led to noticeable weight loss and assisted individuals in stopping smoking. Semaglutide targets specific receptors in the body that control appetite and food intake. Additionally, it has been linked to improved success in quitting smoking. These findings suggest that semaglutide might effectively support both weight loss and smoking cessation. ^{1 2 5 6 7}

Who Is on the Research Team?

Luba Yammine, PhD

Principal Investigator

The University of Texas Health Science Center, Houston

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

My BMI is over 30, or it's over 27 with a condition like high blood pressure, heart disease, high cholesterol, or sleep apnea.

I agree to use birth control if I can have children, unless my partner had a vasectomy.

My doctor agrees I'm fit for the study based on my health history and a quick check-up.

Exclusion Criteria

Systolic blood pressure (SBP) >159 mmHg and/or diastolic blood pressure (DBP) >99 mmHg)

Psychoactive substance abuse or dependence (excluding nicotine dependence) within the past 3 months prior to screening (existing diagnosis or as determined by the structured interview).

Urine drug test positive, before randomization, for any of the following substances: benzodiazepines, cocaine, opioids, amphetamines, methamphetamine, buprenorphine, barbiturates, 3,4-methylenedioxy-methamphetamine (MDMA), Tetrahydrocannabinol (THC)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive semaglutide 2.4mg or placebo to assess its effect on weight management during smoking cessation

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Semaglutide

Trial Overview 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.

How Is the Trial Designed?

Group I: semaglutide Experimental Treatment 3 Interventions

Group II: placebo Placebo Group 3 Interventions

Semaglutide is already approved in European Union, United States, Canada, Japan for the following indications:

Approved in European Union as Ozempic for:

• Type 2 diabetes
• Cardiovascular disease
• Obesity

Approved in United States as Ozempic for:

• Type 2 diabetes
• Cardiovascular disease
• Obesity

Approved in Canada as Ozempic for:

• Type 2 diabetes
• Cardiovascular disease
• Obesity

Approved in Japan as Ozempic for:

• Type 2 diabetes
• Cardiovascular disease
• Obesity

Approved in United States as Wegovy for:

• Obesity

Approved in United States as Rybelsus for:

• Type 2 diabetes

Who Is Running the Clinical Trial?

The University of Texas Health Science Center, Houston

Lead Sponsor

Trials

974

Recruited

361,000+

Published Research Related to This Trial

In a post hoc analysis of 5,119 subjects from the SUSTAIN clinical trials, semaglutide (0.5 and 1.0 mg) led to significantly higher rates of achieving both ≥1.0% HbA1c reduction and ≥5.0% weight loss compared to other diabetes treatments, with rates ranging from 25% to 59% for semaglutide versus 2% to 23% for comparators.

Semaglutide was well tolerated and exhibited a safety profile similar to other GLP-1 receptor agonists, indicating it is a safe and effective option for managing type 2 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

GREATER COMBINED REDUCTIONS IN HbA1C ≥1.0% AND WEIGHT ≥5.0% WITH SEMAGLUTIDE VERSUS COMPARATORS IN TYPE 2 DIABETES. Rodbard, HW., Bellary, S., Hramiak, I., et al.[2022]

Semaglutide (Ozempic®) is an effective once-weekly treatment for type 2 diabetes, showing superior glucose-lowering effects and greater weight loss compared to other GLP-1 receptor agonists in Phase III clinical trials.

It is approved for use in Belgium for patients with type 2 diabetes who have not achieved adequate control with other antidiabetic therapies, particularly in those with a body mass index of 30 kg/m² or higher.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Semaglutide, once weekly GLP-1 receptor agonist (Ozempic®)]. Scheen, AJ.[2019]

Semaglutide, a once-weekly glucagon-like peptide-1 receptor agonist, has been shown to achieve significant and sustained weight loss in individuals with obesity, surpassing results from previous weight-loss medications, and has been approved for use alongside diet and exercise.

Emerging treatments like tirzepatide and cagrilintide are demonstrating even greater weight loss effects than semaglutide, indicating a shift towards more effective 'weight-centric' strategies for managing obesity and related conditions like type 2 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Once-weekly 2.4 mg Semaglutide for Weight Management in Obesity: A Game Changer? Colin, IM., Gérard, KM.[2022]

Continuing treatment with semaglutide (2.4 mg once weekly) for 48 weeks after an initial 20-week run-in led to a significant weight loss of -7.9%, compared to a weight gain of +6.9% in participants who switched to placebo, highlighting the efficacy of ongoing semaglutide treatment for weight maintenance.

Participants on semaglutide also experienced improvements in waist circumference, systolic blood pressure, and physical functioning, although gastrointestinal side effects were more common in the semaglutide group (49.1%) compared to placebo (26.1%).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Continued Weekly Subcutaneous Semaglutide vs Placebo on Weight Loss Maintenance in Adults With Overweight or Obesity: The STEP 4 Randomized Clinical Trial. Rubino, D., Abrahamsson, N., Davies, M., et al.[2022]

High-dose once-weekly semaglutide has been shown to significantly reduce weight in patients with obesity or overweight, as demonstrated in four phase 3 clinical trials involving various populations, including those with diabetes.

While gastrointestinal side effects were common, semaglutide was generally well tolerated and also led to improvements in cardiometabolic risk factors, such as waist circumference and blood pressure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-Dose Once-Weekly Semaglutide: A New Option for Obesity Management. Bradley, CL., McMillin, SM., Hwang, AY., et al.[2022]

Semaglutide, a GLP-1 receptor agonist approved for type 2 diabetes, shows superior weight loss efficacy compared to other GLP-1 RAs and has been found safe in clinical trials.

In a phase II trial, once-daily semaglutide demonstrated significant weight loss in patients with obesity (without diabetes), meeting the efficacy criteria for antiobesity drugs set by regulatory agencies, suggesting its potential as a future treatment for obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Semaglutide as a promising antiobesity drug. Christou, GA., Katsiki, N., Blundell, J., et al.[2020]

Semaglutide, a glucagon-like peptide-1 receptor agonist, has been shown to produce the largest weight loss of any obesity medication, with an average reduction of about 15% of initial body weight over 68 weeks.

In addition to significant weight loss, semaglutide also improves cardiovascular risk factors and physical functioning, making it a promising option for chronic weight management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Semaglutide for the treatment of obesity. Chao, AM., Tronieri, JS., Amaro, A., et al.[2023]

Semaglutide 2.4 mg, administered weekly, can lead to significant weight loss (average 9.6-17.4% of initial body weight) over 68 weeks, improving obesity-related health issues.

While semaglutide is effective, healthcare providers must evaluate patient suitability carefully, considering factors like safety, potential side effects, and individual health conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Insight on Semaglutide for Chronic Weight Management in Adults: Patient Selection and Special Considerations. Chao, AM., Tronieri, JS., Amaro, A., et al.[2023]

Oral semaglutide (Rybelsus®) has been shown to provide better glycaemic control and promote weight loss in patients with type 2 diabetes (T2DM) compared to standard oral glucose-lowering medications, based on data from the PIONEER clinical trial program involving 9543 patients.

The safety profile of oral semaglutide is similar to other GLP-1 receptor agonists, and it demonstrated cardiovascular safety comparable to placebo in high-risk patients, making it a viable option for T2DM management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Oral semaglutide, first oral GLP-1 receptor agonist (Rybelsus®)]. Paquot, N.[2022]

In a meta-analysis of six randomized controlled trials involving 3962 overweight or obese individuals, subcutaneous semaglutide 2.4 mg administered weekly resulted in significant and sustainable weight loss, with an average reduction of 11.8% in body weight compared to placebo.

Semaglutide was well tolerated, with the most common side effects being mild to moderate gastrointestinal issues, indicating a favorable safety profile for non-diabetic overweight or obese individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of semaglutide 2.4 mg for weight loss in overweight or obese adults without diabetes: An updated systematic review and meta-analysis including the 2-year STEP 5 trial. Qin, W., Yang, J., Deng, C., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11128349/

Targeting GLP-1 receptors to reduce nicotine use disorder Specifically, after six weeks of treatment 46.3 % of participants receiving exenatide + NRT were abstinent compared to 26.8 % of participants treated with ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S1551714425001831

A randomized controlled trial of once-weekly semaglutide ... We anticipate that semaglutide 2.4 mg once-weekly will provide a clinically meaningful effect on weight management in the context of smoking cessation.

3. ddw-online.com ddw-online.com/semaglutide-ozempic-found-to-treat-smoking-addiction-30924-202407/

Semaglutide (Ozempic) found to treat smoking addiction New research has linked semaglutide (the active ingredient in Wegovy and Ozempic) with improved smoking cessation.

4. acpjournals.org acpjournals.org/doi/10.7326/M23-2718

Association of Semaglutide With Tobacco Use Disorder in ... Semaglutide was associated with a lower risk for smoking cessation counseling compared with other antidiabetes medications with HRs ranging from 0.69 to 0.85, ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT07059377

NCT07059377 | Semaglutide for Smoking Cessation in ... Beyond their primary focus, emerging evidence shows improved clinical outcomes such as Major Adverse Cardiovascular Events (MACE) and Obstructive Sleep Apnea ( ...

6. nature.com nature.com/articles/s41380-024-02498-5

Association of semaglutide with reduced incidence and ... In summary, our results show that semaglutide was associated with a lower risk for both incident and relapse of CUD compared to non-GLP-1 RA ...

7. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/77/NCT05530577/Prot_SAP_001.pdf

Effects of Semaglutide on Nicotine Intake and Smoking ... Among numerous barriers to smoking cessation, a commonly cited clinical barrier is patient concerns about weight gain following cessation.