Exenatide for Smoking Cessation

Recruiting at 1 trial location

Overseen By Jessica Vincent

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: The University of Texas Health Science Center, Houston

Must not be taking: NRT, Antidepressants, Corticosteroids, others

Disqualifiers: Substance abuse, Diabetes, Cardiovascular, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 15

Duration: 12 weeks

216 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether exenatide, a medication typically used for diabetes, can help people quit smoking and prevent weight gain after quitting. Participants will receive either exenatide injections or a placebo, along with nicotine patches and counseling. The trial seeks individuals who have smoked at least five cigarettes a day for a year, want to quit within a month, and have a BMI (Body Mass Index) of 25 or higher, often indicating being overweight. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important findings.

Will I have to stop taking my current medications?

The trial requires that you stop using certain medications, such as those for smoking cessation, weight management, and glucose lowering. If you're taking any of these, you may need to stop before joining the study.

Is there any evidence suggesting that exenatide is likely to be safe for humans?

Research has shown that exenatide has been tested to help people quit smoking. In these studies, participants used exenatide once a week along with nicotine patches and counseling. Most participants found the treatment manageable, and serious side effects were rare.

The FDA has already approved exenatide for another use, indicating its safety for that purpose. This provides some reassurance about its general safety. However, since this study is in an early stage, further research is needed to confirm these results.

In summary, exenatide appears safe, with no major safety issues reported in studies so far. However, because research is ongoing, joining a trial might involve unknown risks. Always consult a healthcare provider before making a decision. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for smoking cessation?

Unlike standard smoking cessation treatments like nicotine replacement therapy (NRT) and counseling, exenatide is unique because it focuses on a different mechanism of action. Exenatide, a medication originally used for diabetes, targets the brain's reward system, which could help reduce cravings and withdrawal symptoms more effectively. Researchers are excited about this approach because it offers a new way to tackle nicotine addiction, potentially increasing the success rates for those trying to quit smoking.

What evidence suggests that exenatide might be an effective treatment for smoking cessation?

In this trial, participants will receive either exenatide or a placebo alongside nicotine replacement therapy (NRT) and smoking cessation counseling. Research has shown that combining exenatide with NRT can aid in quitting smoking. Studies have found that it not only increases the chances of quitting but also reduces cravings and withdrawal symptoms. Additionally, exenatide helps prevent weight gain in those who successfully quit. For individuals who smoked more than 20 cigarettes a day, exenatide proved more effective than a placebo. These findings suggest that exenatide could be a helpful tool for those looking to stop smoking. ^{1 3 4 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?

Adults aged 18-75 who smoke at least 5 cigarettes daily for a year, want to quit within a month, have stable vital signs and HbA1C levels between 5.7-6.4%, or BMI ≥25 kg/m2. Women must use birth control and not be pregnant. Excludes those with certain mental health disorders, substance abuse issues, severe diseases like diabetes or cardiovascular conditions, or using weight management drugs.

Inclusion Criteria

Have vital signs as follows: resting pulse between 50 and 95 bpm, BP between 90-150 mmHg systolic and 45-95 mmHg diastolic

Have been smoking ≥5 cigarettes per day for at least 1 year and provide positive cotinine test

I am a woman who can have children and have a negative pregnancy test.

Exclusion Criteria

I cannot speak or understand English well.

I have a serious heart condition.

Urine drug test positive, before randomization, for specified substances

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive once weekly exenatide or placebo injections, daily nicotine patches, and weekly smoking cessation counseling

12 weeks

12 visits (in-person)

Follow-up

Participants are monitored for smoking abstinence and weight gain post-treatment

14 weeks

2 visits (in-person)

Extended Follow-up

Participants are further monitored for smoking abstinence at 24 weeks post-target quit day

12 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Exenatide

Trial Overview The trial is testing if exenatide helps smokers quit while preventing weight gain after quitting compared to placebo. Participants also receive nicotine patches and smoking cessation counseling to support their efforts in quitting smoking.

How Is the Trial Designed?

Group I: Exenatide, NRT, and Smoking Cessation Counseling Active Control 3 Interventions

Participants will receive once weekly exenatide injections, daily nicotine patches (NRT), and once weekly individual smoking cessation counseling sessions.

Group II: Placebo, NRT, and Smoking Cessation Counseling Placebo Group 3 Interventions

Participants will receive once weekly saline injections, daily nicotine patches (NRT), and once weekly individual smoking cessation counseling sessions.

Exenatide is already approved in United States, European Union for the following indications:

Approved in United States as Byetta for:

• Type 2 diabetes mellitus

Approved in United States as Bydureon for:

• Type 2 diabetes mellitus

Approved in United States as Bydureon BCise for:

• Type 2 diabetes mellitus

Approved in European Union as Byetta for:

• Type 2 diabetes mellitus

Approved in European Union as Bydureon for:

• Type 2 diabetes mellitus

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

Bydureon, a long-acting formulation of exenatide, allows for once-weekly injections, significantly reducing glycated hemoglobin (HbA1c) levels while maintaining similar weight loss and better digestive tolerance compared to the original twice-daily formulation.

In clinical comparisons, Bydureon has shown greater efficacy than other glucose-lowering medications like sitagliptin and pioglitazone, without causing hypoglycemia, making it a safer option for managing type 2 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Bydureon: first once weekly GLP-1 receptor agonist (exenatide LAR)]. Scheen, AJ.[2022]

In a study of 150 patients with type 2 diabetes, adding once-weekly exenatide to basal insulin therapy resulted in a significant reduction in HbA1c levels by 0.7% after one year, comparable to the 0.8% reduction seen with once-daily liraglutide.

Patients on exenatide were more likely to achieve an HbA1c of less than 7% compared to those on liraglutide, with no increase in hypoglycemia incidents, indicating that exenatide is a safe and effective addition to insulin therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A real-world, observational study of weekly exenatide added to basal insulin in patients with type 2 diabetes mellitus (NCT02895672). Stryker, MD., Kane, MP., Busch, RS.[2023]

Exenatide is an effective treatment for type 2 diabetes, but its short plasma half-life of 2.4 hours limits its use, leading to the development of products like Byetta™ and Bydureon™.

Recent research has focused on creating long-acting formulations of exenatide through various methods, including sustained-release dosage forms and structural modifications, to enhance its clinical application.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-acting preparations of exenatide. Cai, Y., Wei, L., Ma, L., et al.[2021]

Exenatide extended-release (ER) significantly improves blood sugar control and reduces body weight in patients with type 2 diabetes over 24-30 weeks, with effects maintained for up to 6 years.

It is generally well tolerated with a low risk of hypoglycemia, though common side effects include mild gastrointestinal issues and headaches, making it a convenient once-weekly treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exenatide Extended-Release: An Updated Review of Its Use in Type 2 Diabetes Mellitus. Syed, YY., McCormack, PL.[2018]

Exenatide is an effective treatment for type 2 diabetes that helps lower blood sugar levels and HbA1c without causing hypoglycemia or requiring regular blood glucose monitoring, making it a convenient option for patients.

It not only stimulates insulin secretion and inhibits glucagon but also promotes weight loss and slows gastric emptying, which can be particularly beneficial for overweight or obese patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Medication of the month... Exenatide (Byetta) incretinomimetic in the treatment of type 2 diabetes after failure and as add-on therapy to oral agents]. Scheen, AJ., Van Gaal, LF.[2018]

Exenatide, a GLP-1 receptor agonist approved for type 2 diabetes, significantly reduces glycosylated hemoglobin (HbA1c) by about 1% and promotes weight loss of approximately 5.3 kg over 82 weeks, without causing hypoglycemia.

The treatment is generally safe, with a low risk of acute pancreatitis and manageable side effects like mild nausea, which led to a 6% dropout rate in clinical studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Benefit-risk assessment of exenatide in the therapy of type 2 diabetes mellitus. Gallwitz, B.[2022]

Bydureon® (Bdn) is a long-acting injectable treatment for type 2 diabetes that releases exenatide slowly over two months, minimizing initial release to reduce side effects.

The study identified that peptide acylation is a significant degradation product during the release of exenatide, which may contribute to immunogenicity, highlighting the need for further investigation into the stability and safety of the formulation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characterization of attributes and in vitro performance of exenatide-loaded PLGA long-acting release microspheres. Li, T., Chandrashekar, A., Beig, A., et al.[2021]

Exenatide (Byetta) was prescribed to a female type 2 diabetic patient for glycemic control, but she experienced gastrointestinal disturbances from the first day of treatment.

After eight days of using Exenatide, the patient developed acute pancreatitis, which was confirmed by CT scan; the medication was discontinued, and her symptoms improved with treatment for pancreatitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exenatide and acute pancreatitis. Tripathy, NR., Basha, S., Jain, R., et al.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8517504/

Exenatide Adjunct to Nicotine Patch Facilitates Smoking ... Exenatide, in combination with the NRT improved smoking abstinence, reduced craving and withdrawal symptoms, and decreased weight gain among abstainers.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33831213/

Exenatide Adjunct to Nicotine Patch Facilitates Smoking ... Exenatide, in combination with the NRT improved smoking abstinence, reduced craving and withdrawal symptoms, and decreased weight gain among abstainers.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05610800

Exenatide for Smoking Cessation and Prevention of Weight ... The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure.

4. journals.lww.com journals.lww.com/md-journal/fulltext/2018/01120/exenatide_once_weekly_for_smoking_cessation__study.28.aspx

Exenatide once weekly for smoking cessation Twenty percent of the outcome data will be double entered. In the event of major discrepancies, outcome data will receive 100% source document verification.

5. academic.oup.com academic.oup.com/ntr/article-abstract/27/7/1294/7945832

Exploring Predictors of Treatment Response to GLP-1 ... Exenatide showed stronger benefit versus placebo in participants who smoked >20 cigarettes per day (PP = 81.7%) and in those without prediabetes ...

6. 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 ...

7. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/97/NCT02975297/Prot_SAP_000.pdf

Exenatide Once Weekly for Smoking Cessation Safety of exenatide. Exenatide does ... Combined effects of venlafaxine, nicotine replacement, and brief counseling on smoking cessation.