ObesityPhase 1NCT07808073
A Study of LY4329090 in Participants With Obesity or Overweight Who Are Otherwise Healthy
A Phase 1 study testing LY4329090 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 assess how well LY4329090 is tolerated and what side effects may occur in healthy participants with obesity or overweight. Blood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body. 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?
- LY4329090
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 184 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 22 Sep 2026to Sep 2027
- 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
- Participant must be 18 (21 for Singapore site) to 65 years of age, inclusive, at the time of signing the informed consent.
- Are overtly healthy with no comorbidities related to body mass index (BMI).
- Have a BMI between 27.0 kilograms per square meter (kg/m²) and 40.0 kg/m², inclusive.
- 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, gastrointestinal (GI), endocrine, hematological, or neurological disorders.
- Have a history of chronic medical conditions involving the heart, liver, or kidneys.
- Have either
- ongoing asymptomatic bradycardia defined as less than 50 beats per minute at screening visit
- electrocardiogram (ECG) findings at screening visit of second-degree atrioventricular block or higher, or
- history of symptomatic bradycardia with uncorrected etiology, including diagnosis of sick sinus syndrome.
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- Have an abnormal blood pressure and/or pulse rate at screening.
- Have an obesity induced by other endocrinologic disorders or diagnosed monogenetic or syndromic forms of obesity.
- Have any of the following:
- a diagnosis of hypocalcemia or hypercalcemia, or
- confirmed abnormal laboratory values for calcium and serum phosphorus.
- Have a known, clinically significant gastric emptying abnormality, have undergone weight loss surgery, or have had endoscopic and/or device-based therapy for obesity or have had device removal within the last 6 months.
- Have been diagnosed with type 1 or type 2 diabetes mellitus or have glycated hemoglobin A1c (HbA1c) greater than or equal to (≥) 6.5 percent (%) or 48 millimoles per mole (mmol/mol) at screening.
- Have a history or presence of psychiatric disorders, within the last 2 years, that would present a safety risk or may significantly impair the participant's ability to comply with study procedures.
- Have taken any glucose-lowering medications, including insulin, in the past 3 months before screening.
- Have received any drugs from the incretins class within 90 days prior to screening.
- Have been treated within 3 months prior to screening or plan to be treated with prescription medications that promote weight loss.
- Intend to use any weight loss medications during study participation.
- Prior (within 6 months) or planned (during the study) device-based treatment use for obesity.
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
- Recruiting
Fortrea Clinical Research Unit
Dallas, Texas, 75247
866-429-3700
Gene Voskuhl
- Recruiting
Fortrea Clinical Research Unit
Daytona Beach, Florida, 32117
386-366-6417
Chiamaka Iheme
Singapore1 site, 1 recruiting
- Not yet recruiting
Lilly Centre for Clinical Pharmacology
Singapore, 138623
Jeffer Hann Wei Pang
About this study
Official title: A Phase 1, Participant- and Investigator-Blind, Single-Ascending and Multiple- Ascending Dose Study to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY4329090 in Participants With Obesity or Overweight
The main purpose of this study is to assess how well LY4329090 is tolerated and what side effects may occur in healthy participants with obesity or overweight. Blood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body. Study participants will be in one of 2 parts. For each participant in Part A, the study will last about 10 weeks and will include a stay in the Clinical Research Unit (CRU) lasting 5 nights along with 5 outpatient visits to the CRU. For each participant in Part B, the study will last about 21 weeks and will include 4 stays totaling 11 nights along with 14 outpatient visits to the CRU.
- Conditions
- Obesity, Overweight
- Being tested
- LY4329090, 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.
LY4329090Drug
Administered SC
PlaceboDrug
Administered SC
| Study group | Role | What they receive |
|---|---|---|
| LY4329090 Part A | Experimental | Participants will receive LY4329090 administered subcutaneously (SC) Receives: Drug: LY4329090 |
| Placebo Part A | Experimental | Participants will receive placebo administered SC Receives: Drug: Placebo |
| LY4329090 Part B | Experimental | Participants will receive LY4329090 administered SC Receives: Drug: LY4329090 |
| Placebo Part B | Placebo comparator | Participants will receive placebo administered SC Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Measured: End of Study (Week 28)
Secondary outcomes (4)
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY4329090
Measured: Baseline through Week 28
PK: Time of Maximum Observed Drug Concentration (Tmax) of LY4329090
Measured: Baseline through Week 28
PK: Area Under the Concentration Versus Time Curve (AUC) of LY4329090
Measured: Baseline through Week 28
Pharmacodynamics (PD): Body Weight Change from Baseline
Measured: Baseline through Week 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2026
- Study start22 Sep 2026
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 184 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
- NCT07808073
- Sponsor's protocol ID
- 27900
- Other IDs
- J7O-MC-YVAA
- Status last verified
- Oct 2026
- First submitted
- 3 Sep 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No