Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
LY3549492 · 7 trials · 7 indications
A summary of SAEs regardless of causality, will be reported in the Reported Adverse Events module
A summary of treatment emergent adverse events (TEAEs), SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module.
A summary of TEAEs and SAEs regardless of causality, will be reported in the Reported Adverse Events module
Urinary Excretion of Total Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose
Fecal Excretion of Total Radioactivity Over Time Expressed as a Percentage of the Total
PK: AUC for oral determination of absolute bioavailability (F) of LY3549492
PK: AUC for IV determination of absolute bioavailability (F) of LY3549492
| Arm | Type | Description |
|---|---|---|
| LY3549492 Dose 1 | EXPERIMENTAL | Participants will receive LY3549492 orally |
| LY3549492 Dose 2 | EXPERIMENTAL | Participants will receive LY3549492 orally |
| LY3549492 Dose 3 | EXPERIMENTAL | Participants will receive LY3549492 orally |
| LY3549492 Dose 4 | EXPERIMENTAL | Participants will receive LY3549492 orally |
| LY3549492 Dose 5 | EXPERIMENTAL | Participants will receive LY3549492 orally |
| Placebo | PLACEBO_COMPARATOR | Participants will receive Placebo orally |
| LY3549492 (Treatment Group 1) | EXPERIMENTAL | LY3549492 administered orally. |
| LY3549492 (Treatment Group 2) | EXPERIMENTAL | LY3549492 administered orally. |
| LY3549492 (Treatment Group 3) | EXPERIMENTAL | LY3549492 administered orally. |
| LY3549492 (Treatment Group 4) | EXPERIMENTAL | LY3549492 administered orally. |
| LY3549492 Part A | EXPERIMENTAL | LY3549492 administered orally |
| LY3549492 Part B | EXPERIMENTAL | LY3549492 administered orally |
| Placebo Part A | PLACEBO_COMPARATOR | Placebo administered orally |
| Placebo Part B | PLACEBO_COMPARATOR | Placebo administered orally |
| Carbon-14-Labeled [14C]-LY3549492 - Part A | EXPERIMENTAL | Carbon-14-Labeled \[14C\]-LY3549492 administered as oral solution. |
| LY3549492 + [14C]-LY3549492 - Part B | EXPERIMENTAL | LY3549492 administered as oral solution followed 3 hours later by \[14C\] LY3549492 will be administered as intravenous (IV) infusion. |
| LY3549492 (Part A) | EXPERIMENTAL | LY3549492 administered orally as multiple ascending doses. |
| Placebo (Part A) | PLACEBO_COMPARATOR | Placebo administered orally. |
| LY3549492 + Midazolam + Atorvastatin (Part B) | EXPERIMENTAL | LY3549492 coadministered orally with midazolam and atorvastatin. |
| Placebo + Midazolam + Atorvastatin (Part B) | PLACEBO_COMPARATOR | Placebo coadministered orally with midazolam and atorvastatin. |
| LY3549492 (Part B) | EXPERIMENTAL | LY3549492 administered orally as multiple ascending doses. |
| Name | Type | Description |
|---|---|---|
| LY3549492 | DRUG | Administered orally |
| Placebo | DRUG | Administered orally |
| [14C]-LY3549492 | DRUG | Administered as oral solution. |
| Atorvastatin | DRUG | Administered orally. |
| Midazolam | DRUG | Administered orally. |
Inclusion Criteria: W8M-MC-GN01: * Assigned male at birth * Assigned female at birth, who are of non-childbearing potential W8M-MC-CWMM: * Have a BMI of * ≥ 30 kilograms per square meter (kg/m²) or * ≥ 27 kg/m² and \< 30 kg/m² with at least one weight-related comorbidity * Have had a stable...
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LY3549492 is an investigational small molecule being studied for weight management in adults with obesity or overweight, and for the treatment of type 2 diabetes mellitus. It is also being evaluated in healthy participants as part of early clinical studies.
LY3549492 is being developed by Eli Lilly and Company, a biopharmaceutical company listed on the stock exchange under the ticker LLY.
LY3549492 is in clinical development. It has completed Phase 1 studies in Japanese participants with type 2 diabetes and healthy Japanese participants, and in Chinese participants with type 2 diabetes. A Phase 2 study in adults with obesity or overweight has also been completed.
LY3549492 has been studied in several completed trials. NCT06683508 is a Phase 2 study in adults with obesity or overweight. NCT06869018 is a Phase 1 study in Japanese participants with type 2 diabetes and healthy participants. NCT07073170 is a Phase 1 study in Chinese participants with type 2 diabetes. NCT07232732 is a Phase 1 study in healthy participants and those with overweight or obesity.
LY3549492 is not FDA approved. It is an investigational drug that has completed clinical trials, including Phase 1 and Phase 2 studies, but it remains in clinical development and has not been approved for any use.
Yes, LY3549492 is being studied for weight management in adults with obesity or overweight. A completed Phase 2 trial, NCT06683508, enrolled 288 participants in the United States to compare LY3549492 with placebo in this population.