Health Trials

A Study of LY4174794 in Participants With Obesity or Overweight Who Are Otherwise Healthy

ConditionsObesityOverweight
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorEli Lilly and Company

About this trial

The main purpose of this study is to understand how safe and well-tolerated LY4174794 is in participants with obesity or overweight who are otherwise healthy. Blood tests will be performed to check how much LY4174794 gets into the bloodstream and how long it takes the body to eliminate it.

Participation in this study will last about 30 to 39 weeks (7 to 10 months).

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Are overtly healthy with no comorbidities related to body mass index (BMI), such as type 2 diabetes mellitus or unstable cardiovascular disease

Are overweight with a BMI of ≥27 kilogram per meter square (kg/m²), or have obesity with a BMI of ≥30 kg/ m²

Have had a self-reported stable weight for 3 months prior to screening

Disqualifiers

Have a history or presence of cardiovascular, respiratory, hepatic, renal, GI, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs, or of constituting a risk when taking the study intervention, or of interfering with the interpretation of data

Is an individual of childbearing potential (IOCBP)

Trial design

Design model

Sequential

Treatments tested in this trial

  • LY4174794

    Drug

    Administered SC.

  • LY4174794

    Drug

    Administered IV.

  • Placebo

    Drug

    Administered SC.

Treatment groups

108 Participants
are divided into 4 treatment groups
Group A: Part A: LY4174794Experimental treatment 2 interventions
Group B: Part B: LY4174794Experimental treatment 2 interventions
Group C: Part A & B: PlaceboPlacebo comparator 1 intervention
Group D: Part C: LY4174794Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Part A and C: 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

A summary of TEAEs and SAEs, regardless of causality, will be reported in the Reported Adverse Events module.

Time frame
Baseline through end of the Follow-up (Week 25)
2

Part B: Number of Participants with One or More TEAEs and SAEs Considered by the Investigator to be Related to Study Drug Administration

A summary of TEAEs and SAEs, regardless of causality, will be reported in the Reported Adverse Events module.

Time frame
Baseline through end of the Follow-up (Week 33)

Secondary outcomes

1

Part A and C: Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY4174794

Time frame
Predose on day 1 through end of the Follow-up Period (Week 25)
2

Part A and C: PK: Area Under the Concentration Versus Time Curve (AUC) of LY4174794

Time frame
Predose on day 1 through end of the Follow-up Period (Week 25)
3

Part B: PK: Maximum Observed Drug Concentration (Cmax) of LY4174794

Time frame
Predose on day 1 through end of the Follow-up Period (Week 33)
4

Part B: PK: Area Under the Concentration Versus Time Curve (AUC) of LY4174794

Time frame
Predose on day 1 through end of the Follow-up Period (Week 33)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Eli Lilly and Company

Lead sponsor

Source ClinicalTrials.gov
Apply now