A Study of LY3457263 in Obese Participants

Lilly

Status and phase: Completed; Phase 1

Conditions: Overweight; Obesity

Treatments: Drug: Placebo; Drug: LY3457263; Drug: Tirzepatide

Study type: Interventional

Funder types: Industry

Identifiers

NCT05582096

18463

J1R-MC-GZFC (Other Identifier)

Details and patient eligibility

About

The main purpose of this study is to evaluate the safety and tolerability of LY3457263 when administered in combination with tirzepatitide in overweight or obese participants. The study will also evaluate how much of LY3457263 gets into the blood stream and how long it takes the body to remove it in overweight or obese participants. The study will last up to approximately 11 weeks.

Enrollment: 38 patients

Sex: All

Ages: 20 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Participants who are overtly healthy as determined by medical evaluation
• Have a stable body weight and body mass index (BMI) within the range 27.0 to 45.0 kilograms per meter squared (kg/m²)
• Male or female participants not of childbearing potential

Exclusion criteria

• Have a mean sitting systolic blood pressure (BP) higher than 160 millimeters of mercury (mmHg) or a mean sitting diastolic BP higher than 90 mmHg from 3 measurements
• Have an abnormal 12-lead electrocardiogram (ECG) at screening
• Have type 1 or type 2 diabetes mellitus

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

38 participants in 2 patient groups, including a placebo group

LY3457263 + Tirzepatide

Experimental group

Description:

LY3457263 administered subcutaneously (SC) in combination with tirzepatide given SC.

Treatment:

Drug: Tirzepatide

Drug: LY3457263

Placebo + Tirzepatide

Placebo Comparator group

Description:

Placebo administered SC in combination with tirzepatide given SC.

Treatment:

Drug: Tirzepatide

Drug: Placebo