Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
LY2881835 · 1 trial · 1 indication
Clinically significant adverse effects are treatment emergent adverse events (TEAEs) possibly related to study drug.
| Arm | Type | Description |
|---|---|---|
| LY2881835 | EXPERIMENTAL | One cohort of healthy participants will receive single oral doses of LY2881835 in up to 3 of the 4 periods in Part A (dose escalation: 0.5 milligram (mg), 1.5 mg, subsequent doses determined based on review of safety, tolerability, glycaemic response and available pharmacokinetic (PK) data from the first 2 dose levels). One cohort of participants with Type 2 Diabetes Mellitus (T2DM) will receive single oral doses of LY2881835 in up to 2 of the 3 periods in Part B (dose escalation: starting dose based on review of safety, tolerability, glycaemic response and available PK data from Part A). There is a washout period of at least 5 days between periods (doses). |
| placebo | PLACEBO_COMPARATOR | One cohort of healthy participants will receive a single oral dose of placebo in 1 of the 4 periods in Part A. Another cohort of participants with T2DM will receive a single oral dose of placebo in 1 of the 3 periods in Part B. There is a washout period of at least 5 days between periods (doses). |
| Name | Type | Description |
|---|---|---|
| LY2881835 | DRUG | Administered orally |
| Placebo | DRUG | Administered orally |
Inclusion Criteria: All subjects: * Are a healthy male or a healthy female who cannot become pregnant, or are patients with Type 2 Diabetes Mellitus (T2DM) who are not taking any drugs to lower blood sugar except metformin * Have a body mass index (BMI) of at least 18.5 kilograms per meter squared...
LY2881835 is an investigational small molecule being studied for the treatment of Type 2 Diabetes Mellitus. It is in Phase 1 clinical development and has not been approved by regulatory authorities. The drug is being evaluated for its safety and tolerability in people with diabetes.
LY2881835 is being developed by Eli Lilly and Company, a pharmaceutical company traded on the NYSE under the ticker symbol LLY. The company is conducting clinical research to evaluate the drug's potential in treating Type 2 Diabetes Mellitus.
LY2881835 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by the FDA or other regulatory agencies. The drug is being studied for safety and tolerability in early-stage clinical trials.
LY2881835 has been studied in one completed Phase 1 clinical trial, identified as NCT01358981. This trial was titled 'A Study of LY2881835 in Healthy People and People With Diabetes' and enrolled 18 participants in Singapore. The trial was placebo-controlled and included healthy volunteers.
No, LY2881835 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for Type 2 Diabetes Mellitus. The drug has not completed the clinical trials and regulatory review process required for marketing approval.