A Study of LY3541105 in Healthy and Overweight Participants

• Sponsor: Eli Lilly and Company (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05380323
• Collaborator: (none)
• Enrollment: 160
• Locations: 2
• Arms: 4
• Anticipated Duration (Months): 14.8
• Patients Per Site: 80
• Patients Per Site Per Month: 5.4

Study Details

Study Description

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. This is a 2-part study and may last up to 15 and 26 weeks for each participant and may include up to 7 and 15 visits in parts A and B, respectively.

Condition or Disease	Intervention/Treatment	Phase
Overweight; Healthy	Drug: LY3541105; Drug: Placebo	Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 160 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Basic Science
• 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
• Actual Study Start Date: May 10, 2022
• Anticipated Primary Completion Date: Aug 4, 2023
• Anticipated Study Completion Date: Aug 4, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: LY3541105 (Part A) Single ascending doses of LY3541105 administered subcutaneously (SC).	Drug: LY3541105; Administered SC.
Experimental: LY3541105 (Part B) Multiple ascending doses of LY3541105 administered SC.	Drug: LY3541105; Administered SC.
Placebo Comparator: Placebo (Part A) Placebo administered SC.	Drug: Placebo; Administered SC.
Placebo Comparator: Placebo (Part B) Placebo administered SC.	Drug: Placebo; Administered SC.

Outcome Measures

Primary Outcome Measures

1. 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 [Predose up to 26 weeks]

   A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module

Secondary Outcome Measures

1. Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3541105 [Predose through day 43 (Part A) & day 64 (Part B)]

   PK: AUC of LY3541105

2. PK: Time of Maximum observed Concentration (Tmax) of LY3541105 [Predose through day 43 (Part A) & day 64 (Part B)]

   PK: Tmax of LY3541105

3. PK: Maximum Observed Concentration (Cmax) of LY3541105 [Predose through day 43 (Part A) & day 64 (Part B)]

   PK: Cmax of LY3541105

4. Pharmacodynamics (PD): Absolute and Percentage Change from Baseline in Body Weight [Predose through week 26 (Part B Only)]

   PD: Absolute and Percentage Change from Baseline in Body Weight

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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)

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	PRA International	Lenexa	Kansas	United States	66219
2	ICON Early Phase Services	San Antonio	Texas	United States	78209

Sponsors and Collaborators

• Eli Lilly and Company

Investigators

• Study Director: 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), Eli Lilly and Company

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Eli Lilly and Company
• ClinicalTrials.gov Identifier: NCT05380323
• Other Study ID Numbers: 18350; J3S-MC-YEAA
• First Posted: May 18, 2022
• Last Update Posted: Jun 9, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Eli Lilly and Company: Obesity
• Additional relevant MeSH terms: Overweight

Study Results

No Results Posted as of Jun 9, 2022