A Study of LY3541105 in Healthy and Overweight Participants

Lilly

Status and phase: Completed; Phase 1

Conditions: Healthy; Overweight

Treatments: Drug: Placebo; Drug: LY3541105

Study type: Interventional

Funder types: Industry

Identifiers

NCT05380323

18350

J3S-MC-YEAA (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 206 patients

Sex: All

Ages: 21 to 65 years old

Volunteers: Accepts Healthy Volunteers

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 and C)
• 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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206 participants in 6 patient groups, including a placebo group

LY3541105 (Part A)

Experimental group

Description:

Single ascending doses of LY3541105 administered subcutaneously (SC).

Treatment:

Drug: LY3541105

LY3541105 (Part B)

Experimental group

Description:

Multiple ascending doses of LY3541105 administered SC.

Treatment:

Drug: LY3541105

LY3541105 (Part C)

Experimental group

Description:

Escalating doses of LY3541105 administered SC.

Treatment:

Drug: LY3541105

Placebo (Part A)

Placebo Comparator group

Description:

Placebo administered SC.

Treatment:

Drug: Placebo

Placebo (Part B)

Placebo Comparator group

Description:

Placebo administered SC.

Treatment:

Drug: Placebo

Placebo (Part C)

Placebo Comparator group

Description:

Placebo administered SC.

Treatment:

Drug: Placebo