NCT07654972

Brief Summary

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).

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
108

participants targeted

Target at P75+ for phase_1 obesity

Timeline
34mo left

Started Jun 2026

Longer than P75 for phase_1 obesity

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress2%
Jun 2026Apr 2029

Study Start

First participant enrolled

June 1, 2026

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

June 12, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 17, 2026

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2029

Last Updated

June 17, 2026

Status Verified

June 1, 2026

Enrollment Period

2.8 years

First QC Date

June 12, 2026

Last Update Submit

June 12, 2026

Conditions

ObesityOverweight

Outcome Measures

Primary Outcomes (2)

  • 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.

    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

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

    Baseline through end of the Follow-up (Week 39)

Secondary Outcomes (4)

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

    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

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

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

    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

    Predose on day 1 through end of the Follow-up Period (Week 39)

Study Arms (4)

Part A: LY4174794

EXPERIMENTAL

Participants will receive LY4174794 administered subcutaneously (SC).

Drug: LY4174794Drug: Placebo

Part B: LY4174794

EXPERIMENTAL

Participants will receive LY4174794 administered SC.

Drug: LY4174794Drug: Placebo

Part A & B: Placebo

PLACEBO COMPARATOR

Participants will receive placebo administered SC.

Drug: Placebo

Part C: LY4174794

EXPERIMENTAL

Participants will receive LY4174794 administered intravenously (IV).

Drug: LY4174794

Interventions

LY4174794DRUG

Administered SC.

Part A: LY4174794Part B: LY4174794
PlaceboDRUG

Administered SC.

Part A & B: PlaceboPart A: LY4174794Part B: LY4174794

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ICON Early Phase Services, LLC

San Antonio, Texas, 78232, United States

Location

MeSH Terms

Conditions

ObesityOverweight

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)

    Eli Lilly and Company

    STUDY DIRECTOR

Central Study Contacts

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

CONTACT

1-317-615-4559LillyTrials@Lilly.com

Physicians interested in becoming principal investigators please contact

CONTACT

clinical_inquiry_hub@lilly.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 12, 2026

First Posted

June 17, 2026

Study Start

June 1, 2026

Primary Completion (Estimated)

April 1, 2029

Study Completion (Estimated)

April 1, 2029

Last Updated

June 17, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)