Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Mazdutide
LY3305677 · 5 trials · 5 indications
Each ISA will detail the intervention specific analysis.
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).
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. |
| 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. |
| 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 | 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...
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LY3305677 is an investigational small molecule being developed by Eli Lilly and Company for the treatment of type 2 diabetes, obesity, and overweight. It is not yet approved and remains in clinical development, with studies conducted in adults aged 18 and older.
LY3305677 is being studied for type 2 diabetes mellitus, obesity, and overweight. Clinical trials have enrolled adults with type 2 diabetes as well as adults with obesity or overweight, including some healthy volunteers. It is an investigational therapy and has not been approved for any indication.
LY3305677 is developed by Eli Lilly and Company, which trades on the New York Stock Exchange under the ticker LLY. Lilly is running the clinical program, including a Phase 2 master protocol study in adults with obesity or overweight and earlier Phase 1 studies.
LY3305677 is in clinical development. A Phase 1 study in participants with type 2 diabetes and a Phase 1 study in participants with obesity or overweight have both been completed, and a Phase 2 master protocol study in adults with obesity or overweight is currently recruiting.
The active trial is NCT06143956, a Phase 2 master protocol study of multiple intervention-specific appendices in adults with obesity or overweight, recruiting in the United States and Argentina with 1,481 participants. Completed studies include NCT05623839 in obesity or overweight and NCT03928379 in type 2 diabetes.
Across the reported studies, 1,537 participants have been enrolled in LY3305677 trials. The Phase 2 master protocol NCT06143956 accounts for 1,481 of these, while the completed Phase 1 study NCT05623839 enrolled 32 participants and the completed Phase 1 study NCT03928379 enrolled 24.