Clinical trial

A Dose-Escalation Treatment, Phase 1, Investigator- and Participant-Blind, Placebo-controlled Study to Investigate the Safety, Pharmacokinetics, and Pharmacodynamics of Multiple Doses of LY3457263 in Combination With Tirzepatide in Overweight or Obese Participants

NCT05582096

Name

18463

Description

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.

Trial arms

Trial start

2022-11-11

Estimated PCD

2023-06-08

Trial end

2023-06-08

Status

Completed

Phase

Early phase I

Treatment

LY3457263

Administered SC.

Arms:

LY3457263 + Tirzepatide

Tirzepatide

Administered SC.

Arms:

LY3457263 + Tirzepatide, Placebo + Tirzepatide

Other names:

LY3298176

Placebo

Administered SC.

Arms:

Placebo + Tirzepatide

Size

Primary endpoint

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

Baseline up to 11 weeks

Eligibility criteria

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 38, 'type': 'ACTUAL'}}

Updated at

2023-07-18

1 organization

3 products

1 indication

Organization

Eli Lilly and Company

Product

Indication

Product

Product