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

Trial Summary

What is the purpose of 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.

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.

What data supports the effectiveness of the drug Semaglutide for weight management after quitting smoking?

Research shows that Semaglutide, a drug used for weight management, has been effective in helping people lose significant weight, with reductions of about 15% of initial weight over 68 weeks. It has also been shown to help people with type 2 diabetes achieve both weight loss and better blood sugar control. ^{1 2 3 4 5}

Is semaglutide safe for humans?

Semaglutide has been shown to be generally safe in humans for managing type 2 diabetes and weight loss, with studies indicating it is well-tolerated and has a safety profile similar to other medications in its class. It has been tested in various forms, including injections and oral tablets, and is considered safe for use in people with high cardiovascular risk. ^{4 6 7 8 9}

How is the drug semaglutide unique for weight management after quitting smoking?

Semaglutide is unique because it is a once-weekly injection that not only helps with weight loss but also improves blood sugar control, making it different from other weight management drugs. It has shown superior weight loss results compared to other similar treatments, and it is already approved for managing obesity and type 2 diabetes. ^{1 2 3 6 10}

Research Team

Luba Yammine, PhD

Principal Investigator

The University of Texas Health Science Center, Houston

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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, 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]

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 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]

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]

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]

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]

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]

References

1. United States 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. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

GREATER COMBINED REDUCTIONS IN HbA1C ≥1.0% AND WEIGHT ≥5.0% WITH SEMAGLUTIDE VERSUS COMPARATORS IN TYPE 2 DIABETES. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Semaglutide for the treatment of obesity. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

High-Dose Once-Weekly Semaglutide: A New Option for Obesity Management. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Once-weekly 2.4 mg Semaglutide for Weight Management in Obesity: A Game Changer? [2022]

6. Belgium pubmed.ncbi.nlm.nih.gov

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

7. England 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. [2023]

8. New Zealand pubmed.ncbi.nlm.nih.gov

Clinical Insight on Semaglutide for Chronic Weight Management in Adults: Patient Selection and Special Considerations. [2023]

9. Belgium pubmed.ncbi.nlm.nih.gov

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

10. England pubmed.ncbi.nlm.nih.gov

Semaglutide as a promising antiobesity drug. [2020]