NCT05380323

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
206

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started May 2022

Typical duration for phase_1

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 1, 2022

Completed
9 days until next milestone

Study Start

First participant enrolled

May 10, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 18, 2022

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 27, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 27, 2024

Completed
Last Updated

June 27, 2025

Status Verified

June 1, 2025

Enrollment Period

2.3 years

First QC Date

May 1, 2022

Last Update Submit

June 24, 2025

Conditions

OverweightHealthy

Keywords

Obesity

Outcome Measures

Primary Outcomes (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

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

    Predose up to 26 weeks

Secondary Outcomes (4)

  • Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3541105

    Predose through day 43 (Part A) & day 78 (Part B)

  • PK: Time of Maximum observed Concentration (Tmax) of LY3541105

    Predose through day 43 (Part A) & day 78 (Part B)

  • PK: Maximum Observed Concentration (Cmax) of LY3541105

    Predose through day 43 (Part A) & day 78 (Part B)

  • Pharmacodynamics (PD): Absolute and Percentage Change from Baseline in Body Weight

    Predose through week 26 (Part B Only)

Study Arms (6)

LY3541105 (Part A)

EXPERIMENTAL

Single ascending doses of LY3541105 administered subcutaneously (SC).

Drug: LY3541105

LY3541105 (Part B)

EXPERIMENTAL

Multiple ascending doses of LY3541105 administered SC.

Drug: LY3541105

LY3541105 (Part C)

EXPERIMENTAL

Escalating doses of LY3541105 administered SC.

Drug: LY3541105

Placebo (Part A)

PLACEBO COMPARATOR

Placebo administered SC.

Drug: Placebo

Placebo (Part B)

PLACEBO COMPARATOR

Placebo administered SC.

Drug: Placebo

Placebo (Part C)

PLACEBO COMPARATOR

Placebo administered SC.

Drug: Placebo

Interventions

LY3541105DRUG

Administered SC.

LY3541105 (Part A)LY3541105 (Part B)LY3541105 (Part C)
PlaceboDRUG

Administered SC.

Placebo (Part A)Placebo (Part B)Placebo (Part C)

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

PRA International

Lenexa, Kansas, 66219, United States

Location

ICON Early Phase Services

San Antonio, Texas, 78209, United States

Location

MeSH Terms

Conditions

OverweightObesity

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • 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 DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 1, 2022

First Posted

May 18, 2022

Study Start

May 10, 2022

Primary Completion

August 27, 2024

Study Completion

August 27, 2024

Last Updated

June 27, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations

US(2)