Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as LY3305677
Mazdutide · 5 trials · 5 indications
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).
Each ISA will detail the intervention specific analysis.
A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
| Arm | Type | Description |
|---|---|---|
| Mazdutide | EXPERIMENTAL | Mazdutide administered subcutaneously (SC). |
| Placebo | PLACEBO_COMPARATOR | Placebo administered SC. |
| 3/6 Milligrams (mg) Mazdutide | EXPERIMENTAL | Participants 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 Mazdutide | EXPERIMENTAL | Participants 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 Mazdutide | EXPERIMENTAL | Participants 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. |
| LY3305677 Obesity ISA OXA1 | EXPERIMENTAL | Participants will receive LY3305677 or placebo subcutaneously (SC). Each ISA will detail the intervention specific analysis. |
| LY3841136 Obesity ISA LAA1 | EXPERIMENTAL | Participants will receive LY3841136 or placebo SC. Each ISA will detail the intervention specific analysis. |
| LY3841136 Obesity ISA LAA2 | EXPERIMENTAL | Participants will receive LY3841136, tirzepatide and placebo SC. Each ISA will detail the intervention specific analysis. |
| LY3549492 Obesity ISA GN01 | EXPERIMENTAL | Participants will receive LY3549492 or placebo orally. Each ISA will detail the intervention specific analysis. |
| LY3549492 Obesity ISA GN02 | EXPERIMENTAL | Participants will receive LY3549492 or placebo orally. Each ISA will detail the intervention specific analysis. |
| Obesity ISA MC01 | EXPERIMENTAL | Participants will receive macupatide, eloralintide, and placebo SC. Each ISA will detail the intervention specific analysis. |
| LY3305677 | EXPERIMENTAL | LY3305677 administered subcutaneously (SC) |
| Name | Type | Description |
|---|---|---|
| Mazdutide | DRUG | Administered SC |
| Placebo | DRUG | Administered SC |
| LY3305677 | DRUG | Administered SC. ISA specific interventions will be listed in the ISA. |
| LY3841136 | DRUG | Administered SC. ISA specific interventions will be listed in the ISA. |
| Tirzepatide | DRUG | Administered SC. ISA specific interventions will be listed in the ISA. |
| LY3549492 | DRUG | Administered orally. ISA specific interventions will be listed in the ISA. |
| LY3532226 | DRUG | Administered SC. ISA specific interventions will be listed in the ISA. |
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...
Mazdutide is an investigational small molecule being developed by Eli Lilly and Company for Alcohol Use Disorder and Obesity. It is in Phase 2 clinical development. The drug has been studied in randomized, double-blind, placebo-controlled trials, including one trial in Alcohol Use Disorder and one in Obesity or Overweight.
Mazdutide is being studied for the treatment of Alcohol Use Disorder and for Obesity or Overweight. It is not approved for any indication and remains in Phase 2 clinical development. The completed Phase 2 trial in Alcohol Use Disorder enrolled 308 participants, and the completed Phase 2 trial in Obesity or Overweight enrolled 179 participants.
Mazdutide is being developed by Eli Lilly and Company, which trades on the New York Stock Exchange under the ticker LLY. The company is the sponsor of the Phase 2 clinical trials evaluating mazdutide in Alcohol Use Disorder and in Obesity or Overweight.
Mazdutide is in Phase 2 clinical development. Both completed trials were Phase 2 studies: one in Alcohol Use Disorder and one in Obesity or Overweight. The drug is investigational and has not been approved by the FDA for any indication.
Mazdutide has been evaluated in two completed Phase 2 trials. NCT06817356 compared mazdutide with placebo in 308 participants with Alcohol Use Disorder in the United States. NCT06124807 studied LY3305677 compared with placebo in 179 adults with Obesity or Overweight in the United States. Both trials were randomized, double-blind, and placebo-controlled.
Yes, mazdutide is also known as LY3305677. The Phase 2 trial NCT06124807 in adults with Obesity or Overweight was conducted under the name LY3305677, while the Phase 2 trial NCT06817356 in Alcohol Use Disorder was conducted under the name mazdutide. Both refer to the same investigational drug developed by Eli Lilly and Company.