Clinical trial

A Multiple Dose Combination Study to Evaluate the Safety and Tolerability of Tirzepatide and LY3841136 in Overweight and Obese Participants

Name

18834

Description

The main purpose of this study is to assess the safety and tolerability of LY3841136 when administered in combination with tirzepatide in overweight and obese patients. The study will last up to approximately 42 weeks.

Trial arms

Trial start

2024-04-03

Estimated PCD

2025-03-01

Trial end

2025-03-01

Status

Recruiting

Phase

Early phase I

Treatment

Tirzepatide

Administered SC.

Arms:

LY3841136 + Tirzepatide, Placebo + Tirzepatide

LY3841136

Administered SC.

Arms:

LY3841136 + Tirzepatide

Placebo

Administered SC.

Arms:

Placebo + Tirzepatide

Size

Primary endpoint

Number of Participants With One or More Treatment Emergent Adverse Event(s) (TEAEs) and Serious Adverse Event(s) (SAEs) considered by the investigator to be related to study drug administration

Baseline up to 42 weeks

Eligibility criteria

Inclusion Criteria: * Male and female participants who are overtly healthy as determined by medical evaluation * Have a stable body weight and Body Mass Index in range of 27 to 45 kilogram per meter square (kg/m²). * Have clinical laboratory test results within normal reference range * Have venous access sufficient to allow for blood sampling * Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures Exclusion Criteria: * Have type 1 or type 2 diabetes mellitus * Have an abnormal 12-lead electrocardiogram (ECG) * Have a history or presence of psychiatric disorders * Have abnormal blood pressure and pulse rate * Are currently enrolled in another clinical study trial involving medical research or have participated within the last 30 days in a clinical study involving an investigational product.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 80, 'type': 'ESTIMATED'}}

Updated at

2024-04-19

1 organization

3 products

1 indication

Organization

Eli Lilly and Company

Product

Indication

Product

Product