Mazdutide for Alcoholism

Recruiting at 26 trial locations

Overseen By There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Eli Lilly and Company

Must not be taking: Disulfiram, Acamprosate, Naltrexone, others

Disqualifiers: Major depressive disorder, Suicidal ideation, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 28 weeks

300 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires that you have not taken any medication for alcohol use disorder in the last 30 days. It does not specify about other medications, so it's best to discuss your current medications with the trial team.

What data supports the effectiveness of the drug Mazdutide for alcoholism?

Research on similar treatments, like exenatide, a GLP-1 receptor agonist, shows potential in reducing alcohol consumption in certain groups, such as obese patients. This suggests that drugs targeting similar pathways might help in treating alcohol use disorder. ^{1 2 3 4 5}

How does the drug Mazdutide differ from other treatments for alcoholism?

Mazdutide is unique because it is a glucagon-like peptide-1 receptor agonist (GLP-1RA), similar to semaglutide, which has shown promise in reducing alcohol consumption in preclinical studies. This mechanism is different from traditional treatments like naltrexone and acamprosate, which target opioid and glutamate receptors, respectively. ^{1 4 6 7 8}

What is the purpose of this trial?

The objective of this proof-of-concept study to evaluate mazdutide in participants with alcohol use disorder (AUD). For any individual participant, the maximum duration of study participation is approximately 36 weeks, including screening and posttreatment follow-up.

Research Team

Contact Lilly at 1-800-LillyRx (1-800-545-5979)

Principal Investigator

Eli Lilly and Company

Eligibility Criteria

This trial is for individuals who have been diagnosed with Alcohol Use Disorder (AUD) according to the DSM-5 criteria. It's designed to see if a new medication, Mazdutide, can help them.

Inclusion Criteria

I have been diagnosed with Alcohol Use Disorder (AUD).

Timeline

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

Treatment

Participants receive either mazdutide or placebo administered subcutaneously

28 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Mazdutide

Trial Overview The study tests Mazdutide against a placebo in people with AUD. Participants will be randomly assigned to receive either the actual drug or a placebo for up to 36 weeks, including screening and follow-up.

Participant Groups

Group I: Mazdutide Experimental Treatment 1 Intervention

Mazdutide administered subcutaneously (SC).

Group II: Placebo Placebo Group 1 Intervention

Placebo administered SC.

Who Is Running the Clinical Trial?

Eli Lilly and Company

Lead Sponsor

Trials

2,708

Recruited

3,720,000+

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University

Findings from Research

The FDA has approved three main drugs for treating alcoholism: disulfiram, naltrexone, and acamprosate, which are specifically designed to help individuals with alcohol dependence.

There is ongoing research into other medications, such as nalmafene, topiramate, and ondansetron, which are being used off-label, indicating a potential for new treatment options as our understanding of alcoholism improves.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Drug adjuncts for treating alcohol dependence. Collins, GB., McAllister, MS., Adury, K.[2019]

In a 12-week clinical trial with 150 alcohol-dependent individuals, topiramate significantly improved overall well-being, quality of life, and reduced harmful drinking consequences compared to placebo.

Topiramate not only helped participants drink less but also enhanced their psychosocial functioning, indicating its potential as an effective treatment for alcohol dependence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oral topiramate reduces the consequences of drinking and improves the quality of life of alcohol-dependent individuals: a randomized controlled trial. Johnson, BA., Ait-Daoud, N., Akhtar, FZ., et al.[2022]

In a study of 49 veterans prescribed pioglitazone for diabetes, the Alcohol Use Disorder Identification Test-Consumption (AUDIT-C) scores significantly decreased from an average of 3.98 to 2.89, indicating reduced alcohol consumption after starting the medication.

This study is the first to suggest that pioglitazone may effectively reduce alcohol use in patients with heavy drinking, highlighting the need for further clinical trials to explore its potential as a treatment for alcohol use disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reduced alcohol use in patients prescribed pioglitazone. Dieperink, E., Hauser, P., Dockter, K., et al.[2021]

A systematic review of 29 randomized placebo-controlled trials involving 5997 alcohol-dependent patients found that naltrexone significantly reduces heavy drinking in 70% of the studies, highlighting its efficacy in this area.

However, naltrexone showed less effectiveness in promoting abstinence, with only 36% of trials demonstrating an advantage over placebo, suggesting that its primary benefit lies in reducing excessive drinking rather than achieving complete sobriety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The status of naltrexone in the treatment of alcohol dependence: specific effects on heavy drinking. Pettinati, HM., O'Brien, CP., Rabinowitz, AR., et al.[2013]

Acamprosate and naltrexone are the only two medications approved for treating alcohol use disorders (AUDs) that have strong evidence from numerous clinical trials, making them effective options for patients.

Several off-label medications, such as topiramate and gabapentin, show promise for treating AUDs, but more research is needed to confirm their efficacy and safety in this context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacotherapy of alcoholism - an update on approved and off-label medications. Soyka, M., Müller, CA.[2018]

In a case series of 6 patients with alcohol use disorder (AUD) treated with semaglutide for weight loss, all patients showed significant improvement in AUD symptoms, with an average reduction of 9.5 points on the AUDIT scale (P < 0.001).

These findings suggest that glucagon-like peptide-1 receptor agonists (GLP-1RAs) like semaglutide may be a promising new treatment option for AUD, although further randomized clinical trials are necessary to confirm these results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Significant Decrease in Alcohol Use Disorder Symptoms Secondary to Semaglutide Therapy for Weight Loss: A Case Series. Richards, JR., Dorand, MF., Royal, K., et al.[2023]

References

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

Exenatide once weekly for alcohol use disorder investigated in a randomized, placebo-controlled clinical trial. [2022]

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

Drug adjuncts for treating alcohol dependence. [2019]

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

Oral topiramate reduces the consequences of drinking and improves the quality of life of alcohol-dependent individuals: a randomized controlled trial. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Reduced alcohol use in patients prescribed pioglitazone. [2021]

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

The status of naltrexone in the treatment of alcohol dependence: specific effects on heavy drinking. [2013]

6. England pubmed.ncbi.nlm.nih.gov

Activation of PPARγ by pioglitazone potentiates the effects of naltrexone on alcohol drinking and relapse in msP rats. [2018]

7. England pubmed.ncbi.nlm.nih.gov

Pharmacotherapy of alcoholism - an update on approved and off-label medications. [2018]

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

Significant Decrease in Alcohol Use Disorder Symptoms Secondary to Semaglutide Therapy for Weight Loss: A Case Series. [2023]