300 Participants Needed

Mazdutide for Alcoholism

Recruiting at 27 trial locations
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Overseen ByPhysicians interested in becoming principal investigators please contact
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new treatment called mazdutide for people with alcohol use disorder (AUD). Participants will receive either mazdutide, administered as an injection under the skin, or a placebo, which mimics the real treatment. The trial spans up to 36 weeks, including screening and follow-up. Suitable candidates have a current AUD diagnosis and have not used specific AUD medications in the past 30 days. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group of participants.

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.

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

Research has shown that mazdutide has been tested in people for other uses, helping to control blood sugar and reduce body weight. These studies suggest it is generally safe for most people. Although detailed information on side effects is limited, its progression to a Phase 2 study indicates it passed initial safety tests. This suggests it was safe enough in earlier trials to warrant further testing. However, as with any new treatment, unknown risks may exist. Participants might experience some side effects, but the study team will closely monitor them.12345

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

Unlike current treatments for alcoholism, such as behavioral therapies or medications like naltrexone and acamprosate, Mazdutide offers a novel approach by being administered subcutaneously. Researchers are excited about Mazdutide because it targets the condition in a different way, potentially offering more effective results. This treatment could provide a new option for those who have not found success with existing therapies, expanding the possibilities for managing alcoholism.

What evidence suggests that mazdutide might be an effective treatment for alcoholism?

Research has shown that mazdutide, which participants in this trial may receive, might help treat alcohol use disorder (AUD). In a small study, six patients with AUD who took semaglutide, a similar drug, showed significant improvement. These patients drank less alcohol while using semaglutide. Researchers believe mazdutide works similarly, possibly affecting brain chemicals that control cravings and impulse control. Although more research is needed, these early results suggest that mazdutide could help reduce alcohol use in people with AUD.13567

Who Is on the Research Team?

C1

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)

Principal Investigator

Eli Lilly and Company

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: MazdutideExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Eli Lilly and Company

Lead Sponsor

Trials
2,708
Recruited
3,720,000+
Dr. Daniel Skovronsky profile image

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks profile image

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University

Published Research Related to This Trial

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.
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.
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.
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]

Citations

NCT06817356 | A Study to Evaluate Mazdutide Compared ...The objective of this proof-of-concept study to evaluate mazdutide in participants with alcohol use disorder (AUD).
Once-Weekly Semaglutide in Adults With Alcohol Use ...This randomized clinical trial assesses the effects of subcutaneous semaglutide on alcohol consumption in adults with alcohol use disorder.
Mazdutide for AlcoholismIn a case series of 6 patients with alcohol use disorder (AUD) treated with semaglutide for weight loss, all patients showed significant improvement in AUD ...
Once-Weekly Semaglutide in Adults With Alcohol Use DisorderThis randomized clinical trial assesses the effects of subcutaneous semaglutide on alcohol consumption in adults with alcohol use disorder.
A Study to Evaluate Mazdutide Compared With Placebo in ...The objective of this proof-of-concept study to evaluate mazdutide in participants with alcohol use disorder (AUD).
Efficacy and safety of dose-escalated Mazdutide, a GLP-1/ ...It improved glycemic control, reduced weight and uric acid, reversed steatosis, and modulated lipid profiles. These findings support its ...
A Study to Evaluate Mazdutide Compared With Placebo in ...The objective of this proof-of-concept study to evaluate mazdutide in participants with alcohol use disorder (AUD).
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