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Mazdutide

Phase 2

Alcohol Use Disorder | Small molecule | Psychiatry |Eli Lilly and Company|Last Updated: Jul 16, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment308

FDA Designations

No designations recorded

Clinical trial landscape

Mazdutide · 2 trials · 3 indications

Phase 2 2
NCT06817356A Study to Evaluate Mazdutide Compared With Placebo in Participants With Alcohol Use DisorderAlcohol Use Disorder
COMPLETED308 Analytics
NCT06124807A Study of LY3305677 Compared With Placebo in Adult Participants With Obesity or OverweightObesity
COMPLETED179 Analytics
PHASE2COMPLETED
A Study to Evaluate Mazdutide Compared With Placebo in Participants With Alcohol Use Disorder
Alcohol Use DisorderUnlock trial analytics
PHASE2COMPLETED
A Study of LY3305677 Compared With Placebo in Adult Participants With Obesity or Overweight
ObesityUnlock trial analytics

Study Endpoints

Primary Endpoints

Behaviors Associated with Alcohol Use Disorder (AUD) as Assessed by the Timeline Followback Method
Baseline, Week 28
Percent Change From Baseline in Body Weight at Week 32
Baseline, Week 32

Least squares means were calculated using an MMRM model for post-baseline measures: Variable = Baseline\*Time + Strata\*Time + Treatment\*Time, where Treatment and Strata are factors. Variance-Covariance structure (Percent Change from Baseline) = Unstructured. Strata is defined by joint levels of Sex and Baseline BMI (\<=30, \>30 kg/m\^2).

Secondary Endpoints

Percent Change From Baseline in Body Weight at Week 48
Baseline, Week 48
Change From Baseline in Body Weight
Baseline, Week 32, Week 48
Mean Percentage of Participants Who Achieve ≥5% Body Weight Reduction
Baseline, Week 32, Week 48
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeOTHER

Treatment Arms

ArmTypeDescription
MazdutideEXPERIMENTALMazdutide administered subcutaneously (SC).
PlaceboPLACEBO_COMPARATORPlacebo administered SC.
3/6 Milligrams (mg) MazdutideEXPERIMENTALParticipants received once-weekly subcutaneous Mazdutide with dose escalation until the target dose (3 or 6 mg) was achieved, starting at 1.5 mg from Weeks 0-3, followed by 3 mg from Weeks 4-31, then 6 mg from Weeks 32-48.
10 mg MazdutideEXPERIMENTALParticipants received once-weekly subcutaneous Mazdutide with dose escalation until the target dose (10 mg) was achieved, starting at 1.5 mg from Weeks 0-3, followed by 3 mg from Weeks 4-7, 6 mg from Weeks 8-11, 8 mg from Weeks 12-15, and then 10 mg from Weeks 16-48.
16 mg MazdutideEXPERIMENTALParticipants received once-weekly subcutaneous Mazdutide with dose escalation until the target dose (16 mg) was achieved, starting at 1.5 mg from Weeks 0-3, followed by 3 mg from Weeks 4-7, 6 mg from Weeks 8-11, 9 mg from Weeks 12-15, 12 mg from Weeks 16-19, and then16 mg from Weeks 20-48.

Interventions

NameTypeDescription
MazdutideDRUGAdministered SC
PlaceboDRUGAdministered SC
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Eligibility Criteria

Age Range21 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites25

Inclusion Criteria: * Current AUD diagnosis as defined by Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 criteria. Exclusion Criteria: * Have a history of significant active or unstable major depressive disorder, suicidal ideation, or other severe psychiatric disorder within the la...

Countries:United States
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Recent Changes (Last 90 Days)

MEDIUMAug 16, 2026NCT06817356TRIAL_REMOVED: changed
MEDIUMAug 16, 2026NCT06817356TRIAL_REMOVED: changed
MEDIUMAug 16, 2026NCT06817356TRIAL_REMOVED: changed
MEDIUMAug 16, 2026NCT06817356TRIAL_REMOVED: changed
HIGHJul 17, 2026NCT06817356Status: ACTIVE_NOT_RECRUITING → COMPLETED
HIGHJul 17, 2026NCT06817356Status: ACTIVE_NOT_RECRUITING → COMPLETED
HIGHJul 17, 2026NCT06817356Status: ACTIVE_NOT_RECRUITING → COMPLETED
LOWJun 26, 2026NCT06817356Enrollment: 300 → 308
LOWJun 26, 2026NCT06817356Enrollment: 300 → 308

Frequently asked questions about Mazdutide

What is Mazdutide used for?

Mazdutide is an investigational small molecule being studied for the treatment of obesity, overweight, and alcohol use disorder. It is being developed by Eli Lilly and Company (LLY). The drug is currently in Phase 2 clinical development and is not yet approved by the FDA.

What does Mazdutide target?

Mazdutide is a small molecule, but its specific molecular target has not been disclosed in available information. The drug is being investigated for its effects on obesity, overweight, and alcohol use disorder, but the precise mechanism of action is not publicly detailed.

Who makes Mazdutide?

Mazdutide is being developed by Eli Lilly and Company, a pharmaceutical company traded on the NYSE under the ticker symbol LLY. The drug is currently in Phase 2 clinical trials for obesity, overweight, and alcohol use disorder.

What phase is Mazdutide in?

Mazdutide is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA. Two Phase 2 trials have been completed, one in obesity or overweight and one in alcohol use disorder.

What clinical trials is Mazdutide in?

Mazdutide has been studied in two completed Phase 2 trials. NCT06124807 evaluated the drug in 179 adults with obesity or overweight in the United States. NCT06817356 evaluated the drug in 308 adults with alcohol use disorder in the United States.

Is Mazdutide the same as LY3305677?

Yes, Mazdutide is also known as LY3305677. The clinical trial NCT06124807, which studied the drug in participants with obesity or overweight, refers to the compound as LY3305677. Both names refer to the same investigational drug.