LY3541105 for Overweight

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
ICON Early Phase Services, San Antonio, TX
Overweight+1 More
LY3541105 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study 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.

Eligible Conditions

  • Overweight
  • Healthy Subjects (HS)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Overweight

Study Objectives

1 Primary · 4 Secondary · Reporting Duration: Predose through day 43 (Part A) & day 64 (Part B)

Day 64
PK: Maximum Observed Concentration (Cmax) of LY3541105
PK: Time of Maximum observed Concentration (Tmax) of LY3541105
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3541105
Week 26
Pharmacodynamics (PD): Absolute and Percentage Change from Baseline in Body Weight
Week 26
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

Trial Safety

Safety Progress

1 of 3

Other trials for Overweight

Trial Design

4 Treatment Groups

LY3541105 (Part A)
1 of 4
LY3541105 (Part B)
1 of 4
Placebo (Part A)
1 of 4
Placebo (Part B)
1 of 4
Experimental Treatment
Non-Treatment Group

160 Total Participants · 4 Treatment Groups

Primary Treatment: LY3541105 · Has Placebo Group · Phase 1

LY3541105 (Part A)
Drug
Experimental Group · 1 Intervention: LY3541105 · Intervention Types: Drug
LY3541105 (Part B)
Drug
Experimental Group · 1 Intervention: LY3541105 · Intervention Types: Drug
Placebo (Part A)
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
Placebo (Part B)
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug

Trial Logistics

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: predose through day 43 (part a) & day 64 (part b)
Closest Location: ICON Early Phase Services · San Antonio, TX
Photo of San Antonio 1Photo of San Antonio 2Photo of San Antonio 3
2016First Recorded Clinical Trial
2 TrialsResearching Overweight
15 CompletedClinical Trials

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor
2,428 Previous Clinical Trials
3,118,084 Total Patients Enrolled
17 Trials studying Overweight
22,459 Patients Enrolled for Overweight
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)Study DirectorEli Lilly and Company
1,231 Previous Clinical Trials
364,699 Total Patients Enrolled
12 Trials studying Overweight
6,244 Patients Enrolled for Overweight

Eligibility Criteria

Age 18+ · All Participants · 4 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are male and agree to refrain from sperm donation and to use contraceptive methods
You have a body mass index (BMI) in the range of greater than or equal to (>/=) 18.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.