Approval Probability
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LY3084077 · 1 trial · 1 indication
An SAE is an adverse event that results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. A summary of other non-serious adverse events and all serious adverse events, regardless of causality, is located in the Reported Adverse Events Section.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Single dose of placebo matching LY3084077 administered subcutaneously (SC). |
| LY3084077 | EXPERIMENTAL | Single escalating doses (1 mg up to 300 mg) of LY3084077 administered SC. |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | Given as a SC injection. |
| LY3084077 | DRUG | Given as a SC injection. |
Inclusion Criteria: * Have normal blood pressure * Must be a healthy male or female who cannot become pregnant * Have a body mass index (BMI) of 18.5 to 40.0 kg/m\^2, inclusive, at screening Exclusion Criteria: * Have known allergies to fibroblast growth factor-21 (FGF21) analogues, glucagon-like...
LY3084077 is an investigational small molecule being studied in healthy volunteers. It is not approved for any disease and is in early clinical development. The only completed trial evaluated its effects in healthy participants to assess safety and tolerability.
LY3084077 is being developed by Eli Lilly and Company, traded on the New York Stock Exchange under the ticker LLY. The company sponsored a Phase 1 study of the drug in healthy participants.
LY3084077 is in Phase 1 clinical development. The single trial, NCT01846702, was a Phase 1 study that has been completed. The drug remains investigational and has not been approved by regulatory authorities.
LY3084077 has one completed clinical trial, NCT01846702, titled "A Study of LY3084077 in Healthy Participants." This Phase 1, randomized, double-blind, placebo-controlled study enrolled 43 healthy volunteers in Singapore, with participants aged 21 years and older.
LY3084077 is not FDA approved. It is an investigational drug that has completed a Phase 1 trial in healthy volunteers. No efficacy or approval data are available, and the drug remains in clinical development.