LY3541105 for Overweight
Phase-Based Progress Estimates
Effectiveness
Safety
ICON Early Phase Services, San Antonio, TX
Overweight+1 More
LY3541105 - DrugEligibility
18+
All Sexes
What conditions do you have?
Select
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
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
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: DrugLY3541105 (Part B)
Drug
Experimental Group · 1 Intervention: LY3541105 · Intervention Types: DrugPlacebo (Part A)
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: DrugPlacebo (Part B)
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: DrugTrial 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
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 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.
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Cancer Related
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