Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
LY3971297 · 2 trials · 6 indications
Part A and F: A summary of TEAEs and SAEs, regardless of causality, will be reported in the Reported Adverse Events module
Part B, C, D, E, \& G: A summary of TEAEs and SAEs, regardless of causality, will be reported in the Reported Adverse Events module
Part F: PK: AUC of LY3971297
Part F: PK: Cmax of LY3971297
| Arm | Type | Description |
|---|---|---|
| LY3971297 Part A Cohort 1 | EXPERIMENTAL | LY3971297 administered subcutaneously (SC) |
| Placebo Part A Cohort 1 | PLACEBO_COMPARATOR | Placebo administered SC |
| LY3971297 Part A Cohort 2 | EXPERIMENTAL | LY3971297 administered SC |
| Placebo Part A Cohort 2 | PLACEBO_COMPARATOR | Placebo administered SC |
| LY3971297 Part A Cohort 3 | EXPERIMENTAL | LY3971297 administered SC |
| Placebo Part A Cohort 3 | PLACEBO_COMPARATOR | Placebo administered SC |
| LY3971297 Part A Cohort 4 | EXPERIMENTAL | LY3971297 administered SC |
| Placebo Part A Cohort 4 | PLACEBO_COMPARATOR | Placebo administered SC |
| LY3971297 Part A Cohort 5 | EXPERIMENTAL | LY3971297 administered intravenously (IV) |
| Placebo Part A Cohort 5 | PLACEBO_COMPARATOR | Placebo administered IV |
| LY3971297 Part B | EXPERIMENTAL | LY3971297 administered SC or IV |
| Placebo Part B | PLACEBO_COMPARATOR | Placebo administered SC or IV |
| LY3971297 (Part A) | EXPERIMENTAL | Single ascending doses of LY3971297 administered subcutaneously (SC) in healthy participants |
| LY3971297 (Part B) | EXPERIMENTAL | Multiple ascending doses of LY3971297 administered SC in healthy participants |
| LY3971297 (Part C) | EXPERIMENTAL | Multiple ascending doses of LY3971297 administered SC in healthy Chinese participants |
| LY3971297 (Part D) | EXPERIMENTAL | Multiple ascending doses of LY3971297 administered SC |
| LY3971297 (Part E) | EXPERIMENTAL | Multiple doses of LY3971297 administered SC in healthy Japanese participants |
| Placebo (Part A, B, C, D, E, & G) | PLACEBO_COMPARATOR | Placebo administered SC |
| LY3971297 (Part F) | EXPERIMENTAL | Single doses of LY3971297 administered intravenously (IV) in healthy participants |
| LY3971297 (Part G) | EXPERIMENTAL | Multiple doses of LY3971297 administered SC |
| Name | Type | Description |
|---|---|---|
| LY3971297 | DRUG | Administered SC |
| Placebo | DRUG | Administered SC |
| LY3971297 IV | DRUG | Administered IV |
Inclusion Criteria: * Are diagnosed with chronic heart failure with New York Heart Association Class II-III (Heart Failure) HF symptomatology at screening and on guideline-directed HF therapy for at least 6 months prior to screening. * Have not changed optimal guideline-directed HF therapy, either ...
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LY3971297 is an investigational small molecule being developed by Eli Lilly and Company for heart failure and obesity. It is in Phase 1 clinical development and has not been approved by the FDA. Lilly is studying it in placebo-controlled trials, including one completed study in healthy participants and one recruiting study in people with heart failure.
LY3971297 is being studied for heart failure and for obesity. The recruiting Phase 1 trial enrolls adults with heart failure, including diastolic and systolic heart failure, while the completed Phase 1 trial enrolled healthy participants and people with obesity or hypertension. It is investigational and not approved for any use.
LY3971297 is developed by Eli Lilly and Company, which trades on the New York Stock Exchange under the ticker LLY. Lilly is running the Phase 1 program for the small molecule in heart failure and obesity.
LY3971297 is in Phase 1 clinical development. One Phase 1 trial in healthy participants has completed, and a second Phase 1 trial in participants with heart failure is currently recruiting. The drug is investigational and has not received FDA approval.
Two Phase 1 trials of LY3971297 are registered. NCT06148272 studied the drug in healthy participants, including people with obesity or hypertension, and has completed with 200 participants enrolled. NCT07547540 is a recruiting Phase 1 study in participants with heart failure, with planned enrollment of 90, running in the United States, Japan, Moldova, and Romania.
Yes. The LY3971297 Phase 1 program uses placebo-controlled designs. The completed healthy participant study and the recruiting heart failure study are both randomized and placebo controlled, though they are not double blinded. The heart failure trial, NCT07547540, is enrolling adults 18 years and older.