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LY3541105 for Obesity

Phase 1
Recruiting
Research Sponsored by Eli Lilly and Company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up predose through day 43 (part a) & day 64 (part b)
Awards & highlights

Study Summary

This trial is testing the safety and tolerability of a new drug, LY3541105, in healthy and overweight people. Blood tests will be done to see how much of the drug gets into the bloodstream and how long it takes the body to get rid of it. The study will also see if LY3541105 affects body weight.

Who is the study for?
This trial is for healthy or overweight men and women who are not able to have children. Men must agree not to donate sperm and use contraception. Participants should have a stable weight for the past 3 months, with BMIs of 18.5-32 kg/m² in Part A or 27-40 kg/m² in Part B.Check my eligibility
What is being tested?
The study tests LY3541105's safety and how it affects body weight compared to a placebo. It checks how much drug gets into the blood, its elimination rate, and involves two parts lasting up to 15 weeks (Part A) or up to 26 weeks (Part B), with several visits.See study design
What are the potential side effects?
Specific side effects aren't listed but generally include monitoring for any adverse reactions related to safety and tolerability of LY3541105 during the trial period.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~predose through day 43 (part a) & day 64 (part b)
This trial's timeline: 3 weeks for screening, Varies for treatment, and predose through day 43 (part a) & day 64 (part b) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Therapeutic procedure
Secondary outcome measures
PK: Maximum Observed Concentration (Cmax) of LY3541105
PK: Time of Maximum observed Concentration (Tmax) of LY3541105
Pharmacodynamics (PD): Absolute and Percentage Change from Baseline in Body Weight
+1 more

Trial Design

6Treatment groups
Experimental Treatment
Placebo Group
Group I: LY3541105 (Part C)Experimental Treatment1 Intervention
Escalating doses of LY3541105 administered SC.
Group II: LY3541105 (Part B)Experimental Treatment1 Intervention
Multiple ascending doses of LY3541105 administered SC.
Group III: LY3541105 (Part A)Experimental Treatment1 Intervention
Single ascending doses of LY3541105 administered subcutaneously (SC).
Group IV: Placebo (Part B)Placebo Group1 Intervention
Placebo administered SC.
Group V: Placebo (Part C)Placebo Group1 Intervention
Placebo administered SC.
Group VI: Placebo (Part A)Placebo Group1 Intervention
Placebo administered SC.

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor
2,615 Previous Clinical Trials
3,200,853 Total Patients Enrolled
54 Trials studying Obesity
40,828 Patients Enrolled for Obesity
Study DirectorEli Lilly and Company
1,344 Previous Clinical Trials
405,047 Total Patients Enrolled
37 Trials studying Obesity
20,547 Patients Enrolled for Obesity

Media Library

LY3541105 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05380323 — Phase 1
Obesity Research Study Groups: LY3541105 (Part B), Placebo (Part B), Placebo (Part C), LY3541105 (Part C), LY3541105 (Part A), Placebo (Part A)
Obesity Clinical Trial 2023: LY3541105 Highlights & Side Effects. Trial Name: NCT05380323 — Phase 1
LY3541105 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05380323 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the maximum capacity of this research initiative?

"Affirmative. Clinicaltrials.gov reveals that this research project, which was posted on May 10th 2022 and most recently updated on September 7th 2022, is actively seeking participants. The trial needs to recruit 160 patients from two distinct sites."

Answered by AI

Has the FDA greenlit LY3541105 for use?

"The safety of LY3541105 is rated at a 1, as the Phase 1 trial does not possess substantial evidence to guarantee its efficacy or security."

Answered by AI

Is participation in this trial restricted to individuals aged seventy-five and under?

"The age range for inclusion in this medical investigation is between 21 and 65 years of maturity."

Answered by AI

Am I eligible to be a participant in this experiment?

"To be admitted into this clinical trial, a person must have an excess of bodyweight and lie between the ages of 21 to 65. About 160 individuals will be accepted for participation."

Answered by AI

Are there any openings available to participate in the trial?

"This research endeavour is presently recruiting participants, as reported on clinicaltrials.gov – the study was first announced on May 10th 2022 and has been altered most recently on September 7th 2022."

Answered by AI

Who else is applying?

What state do they live in?
Missouri
Other
Texas
Kansas
How old are they?
65+
18 - 65
What site did they apply to?
ICON Early Phase Services
PRA International
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
3+
1
0
~29 spots leftby Sep 2024