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Recruiting NCT07654972

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

Phase I Interventional Obesity Overweight

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: LY4174794, LY4174794, Placebo.
Who it may be relevant to
Registry conditions: Obesity, Overweight. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Singapore
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase 1, Randomized, Placebo-Controlled, Single- and Multiple-Ascending Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY4174794 in Participants With Obesity or Overweight Who Are Otherwise Healthy

Overview

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 35 to 45 weeks (7 to 11 months).

Interventions

  • Drug LY4174794
    Administered SC.
  • Drug LY4174794
    Administered IV.
  • Drug Placebo
    Administered SC.

Primary outcome measures

  • 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 [Time frame: Baseline through end of the Follow-up (Week 25)]
  • Part B: Number of Participants with One or More TEAEs and SAEs Considered by the Investigator to be Related to Study Drug Administration [Time frame: Baseline through end of the Follow-up (Week 39)]
Secondary outcome measures (4)
  • 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)]
  • 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)]
  • Part B: PK: Maximum Observed Drug Concentration (Cmax) of LY4174794 [Time frame: Predose on day 1 through end of the Follow-up Period (Week 39)]
  • 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 39)]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Sequential
Masking
Double blind
Primary purpose
Basic science

Study locations

United States · 2 centers
  • ICON Early Phase Services, LLC — San Antonio
  • ICON Early Phase Services, LLC — Salt Lake City
Singapore · 1 center
  • Lilly Centre for Clinical Pharmacology — Singapore

Identifiers

NCT: NCT07654972 · 27797 · J6W-MC-YMAA

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗