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

Trial Summary

What is the purpose of this trial?

The purpose of this study is to determine if exenatide improves end-of-treatment smoking abstinence rates and to determine if exenatide mitigates post-cessation weight gain.

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 Exenatide safe for humans?

Exenatide, used for type 2 diabetes, is generally safe but can cause nausea and, in rare cases, acute pancreatitis (inflammation of the pancreas). Most side effects are mild and temporary, and it does not increase the risk of low blood sugar. ^{1 2 3 4 5}

How is the drug Exenatide unique for smoking cessation?

Exenatide is unique because it is a once-weekly injectable drug originally used for type 2 diabetes, which works by mimicking a hormone that helps regulate blood sugar and appetite. This long-acting formulation allows for a more convenient dosing schedule compared to other treatments that may require daily administration. ^{1 5 6 7 8}

Research Team

Luba Yammine, PhD

Principal Investigator

The University of Texas Health Science Center, Houston

Eligibility Criteria

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 between 18 and 75 years old.

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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, 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]

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]

References

1. England 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). [2023]

2. Belgium 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]. [2018]

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

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

4. India pubmed.ncbi.nlm.nih.gov

Exenatide and acute pancreatitis. [2018]

5. Belgium pubmed.ncbi.nlm.nih.gov

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

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

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

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

Long-acting preparations of exenatide. [2021]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Characterization of attributes and in vitro performance of exenatide-loaded PLGA long-acting release microspheres. [2021]