ObesityPhase 1NCT07654972
A Study of LY4174794 in Participants With Obesity or Overweight Who Are Otherwise Healthy
A Phase 1 study testing LY4174794 in people with Obesity and Overweight, run by Eli Lilly and Company at 3 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Overweight
- What is being tested?
- LY4174794
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 116 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 24 Jun 2026to Apr 2029
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
3 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or contact
Physicians interested in becoming principal investigators please contact contact
3 sites in 2 countries
United States2 sites, 2 recruiting
- Not yet recruiting
ICON Early Phase Services, LLC
Salt Lake City, Utah, 84124
801-261-3341
Ahad Sabet
- Recruiting
ICON Early Phase Services, LLC
San Antonio, Texas, 78232
(210) 225-5437
Cassandra Key
Singapore1 site, 1 recruiting
- Not yet recruiting
Lilly Centre for Clinical Pharmacology
Singapore, 138623
+65 6413 9811
Jennifer Boon Wee
About this study
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
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).
- Conditions
- Obesity, Overweight
- Being tested
- LY4174794, Placebo
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY4174794Drug
Administered SC.
LY4174794Drug
Administered IV.
PlaceboDrug
Administered SC.
| Study group | Role | What they receive |
|---|---|---|
| Part A: LY4174794 | Experimental | Participants will receive LY4174794 administered subcutaneously (SC). Receives: Drug: LY4174794; Drug: Placebo |
| Part B: LY4174794 | Experimental | Participants will receive LY4174794 administered SC. Receives: Drug: LY4174794; Drug: Placebo |
| Part A & B: Placebo | Placebo comparator | Participants will receive placebo administered SC. Receives: Drug: Placebo |
| Part C: LY4174794 | Experimental | Participants will receive LY4174794 administered intravenously (IV). Receives: Drug: LY4174794 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline through end of the Follow-up (Week 33)
Secondary outcomes (4)
Part A and C: Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY4174794
Measured: 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
Measured: Predose on day 1 through end of the Follow-up Period (Week 25)
Part B: PK: Maximum Observed Drug Concentration (Cmax) of LY4174794
Measured: Predose on day 1 through end of the Follow-up Period (Week 33)
Part B: PK: Area Under the Concentration Versus Time Curve (AUC) of LY4174794
Measured: Predose on day 1 through end of the Follow-up Period (Week 33)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2026
- Study start24 Jun 2026
- Primary completionApr 2029 (estimated)
- Study completionApr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 116 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 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), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07654972
- Sponsor's protocol ID
- 27797
- Other IDs
- J6W-MC-YMAA
- Status last verified
- Oct 2026
- First submitted
- 12 Jun 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No