Clinical trial NCT05380323: A Study of LY3541105 in Healthy and Overweight Participants
Official title: A Phase 1, Randomized, Placebo-Controlled, Dose-Escalation Study to Evaluate the Safety, Tolerability, and PK of LY3541105 Following Single Doses in Healthy/Overweight Participants and Multiple Doses in Overweight Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Overweight
Healthy
Keywords: Obesity
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2022-05-18
Enrollment: 206
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The main purpose of this study is to evaluate the safety and tolerability of LY3541105 in healthy and overweight participants. Blood tests will be performed to check how much LY3541105 gets into the bloodstream and how long it takes the body to eliminate it. The study will also evaluate the effects of LY3541105 on body weight and assess safety and tolerability of LY3541105. This is a 3-part study and may last up to 15, 26 and 24 weeks for each participant and may include up to 7, 15 and 16 visits in parts A, B and C, respectively.


Eligibility criteria: Inclusion Criteria:

* Participants who are overtly healthy as determined by medical evaluation
* Male participants who agree to refrain from sperm donation and to use contraceptive methods and female participants not of childbearing potential
* Have a body mass index (BMI) in the range of greater than or equal to (\>/=) 18.5 to less than (\<) 32 kilogram per square meter (kg/m²), both inclusive (in Part A) or a BMI in the range of \>/=27 to \<40 kg/m², both inclusive (in Part B and C)
* Have had a stable weight for the last 3 months

Exclusion Criteria:

* Have history of diabetes (except gestational diabetes) or current diagnosis of diabetes
* Clinically significant abnormal electrocardiogram (ECG) at screening, as judged by the Investigator
* Have history or current evidence of a clinically significant cardiovascular condition

Primary outcomes:
measure: Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
timeFrame: Predose up to 26 weeks
Secondary outcomes:
measure: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3541105
timeFrame: Predose through day 43 (Part A) & day 64 (Part B)
measure: PK: Time of Maximum observed Concentration (Tmax) of LY3541105
timeFrame: Predose through day 43 (Part A) & day 64 (Part B)
measure: PK: Maximum Observed Concentration (Cmax) of LY3541105
timeFrame: Predose through day 43 (Part A) & day 64 (Part B)
measure: Pharmacodynamics (PD): Absolute and Percentage Change from Baseline in Body Weight
timeFrame: Predose through week 26 (Part B Only)
Other outcomes:
Locations:
city: Lenexa
country: United States
facility: PRA International
state: Kansas
city: San Antonio
country: United States
facility: ICON Early Phase Services
state: Texas
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References: