A Study of LY3872386 in Healthy Participants and Participants With Atopic Dermatitis
Reason given: Based on emerging nonclinical data, the study was terminated.
Key facts
- Where
- Anaheim and Daytona Beach, United StatesSee the 2 sites
- Phase
- Phase 1
Where in United States
- CenExel ACTAnaheim, United StatesNo longer taking part
- Fortrea Clinical Research UnitDaytona Beach, United StatesNo longer taking part
Trial details
- Who runs it
- Eli Lilly and Company
- Trial code
- NCT06119529
- Record updated
- 3 October 2025
- Original description
The main purpose of this study is to evaluate the safety and tolerability of LY3872386 in healthy participants and participants with atopic dermatitis. The safety of prednisone is also evaluated in healthy participants. Blood tests will be performed to investigate how the body processes the LY3872386 following single and multiple dosing in healthy participants and participants with atopic dermatitis. Blood tests will also be performed to investigate how the body processes the prednisone in healthy participants. The study is conducted in three parts (part A, B and C). The study will last up to approximately 85, 183 and 44 days for parts A, B, and C, respectively.Read full original descriptionShow less
A Phase 1, Multicenter, Randomized, Placebo-Controlled, Double-Blind, Single-Ascending Dose Study of LY3872386 in Healthy Participants, a Multiple-Ascending Dose Study of LY3872386 in Patients With Atopic Dermatitis, and an Open-Label Multiple-Dose Evaluation of the Safety and Tolerability of Prednisone in Healthy Participants.
The main purpose of this study is to evaluate the safety and tolerability of LY3872386 in healthy participants and participants with atopic dermatitis. The safety of prednisone is also evaluated in healthy participants. Blood tests will be performed to investigate how the body processes the LY3872386 following single and multiple dosing in healthy participants and participants with atopic dermatitis. Blood tests will also be performed to investigate how the body processes the prednisone in healthy participants. The study is conducted in three parts (part A, B and C). The study will last up to approximately 85, 183 and 44 days for parts A, B, and C, respectively.
Inclusion: Part A and C:; Overtly healthy as determined by medical evaluation; To qualify as Japanese for the purpose of this study, the participant must be first generation Japanese, defined as the participant's biological parents and all of the participant's biological grandparents must be of exclusive Japanese descent, and must have been born in Japan; To qualify as Chinese for the purpose of this study, the participant must be, at a minimum, third-generation Chinese, defined as all 4 of the participant's biological grandparents must be of exclusive Chinese descent and born in China; Have a body mass index of 18.0 to 32.0 kilograms per square meter (kg/m²), inclusive; Male participants who agree to use highly effective or effective methods of contraception and women not of childbearing potential may participate in part A and C; Part B:; Participants who have a diagnosis of atopic dermatitis at least 12 months prior to screening as defined by the American Academy of Dermatology; Have a history, documented by a physician and/or investigator, of inadequate response to existing topical medications within 6 months preceding screening, or participants who failed systemic therapies intended to treat atopic dermatitis or a history of intolerance to topical therapy; Have a body mass index of 18.0 to 38.0 kilograms per square meter (kg/m²), inclusive; Male participants who agree to use highly effective or effective methods of contraception, women not of childbearing potential and women of childbearing potential may participate in part B.
Exclusion: Participants who have received live vaccine(s) (including attenuated live vaccines) or Bacillus Calmette- Guérin within 35 days of screening; Have a history or presence of multiple or severe allergies or an anaphylactic reaction to prescription or nonprescription drugs; Have a known history of diabetes; Have known history of osteoporosis; Have fasting glucose level of ≥126 milligrams per deciliter (mg/dL) and glycated hemoglobin ≥6.5 percent (%) and/or taking anti-diabetes medications at screening; Women who are pregnant and/or lactating.