ObesityPhase 1NCT06557356
A Study of LY3532226 in Participants With Obesity
A Phase 1 study testing LY3532226 in people with Obesity, run by Eli Lilly and Company at 4 sites in 2 countries.
Trial summary
The main purpose of this study is to evaluate the safety and tolerability of the study drug known as LY3532226 in participants with obesity. Blood tests will be performed to check how much LY3532226 gets into the bloodstream and how long it takes the body to eliminate it following weekly or monthly administration. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity
- What is being tested?
- LY3532226
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 132 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 16 Aug 2024to 12 Dec 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have a body weight not exceeding 150 kilograms (kg) or 330 pounds (lb) and body mass index (BMI) within the range of 30 to 40 kilogram per square meter (kg/m²)
- Have had a stable body weight that is less than or equal to 5% change in body weight for 3 months prior to screening and enrollment
Who cannot join
- Have a lifetime history of a suicide attempt
- Have a history or presence of psychiatric disorders, including a history of major depressive disorder within the last 2 years
- Have a baseline Patient Health Questionnaire-9 (PHQ-9) score of 15 or greater, and/or a score of 2 or greater for either of the first 2 questions on the PHQ-9 questionnaire
- Have a known clinically significant gastric emptying abnormality, have undergone gastric bypass surgery or restrictive bariatric surgery
- Have taken approved or investigational medication for weight loss, within the previous 3 months or 5 half-lives of study screening, whichever is earlier
- Intend to use any weight-loss medications during study participation
- Have obesity induced by other endocrinologic disorders or diagnosed monogenetic or syndromic forms of obesity
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
United States3 sites
Fortrea Clinical Research Unit
Dallas, Texas, 75247
Fortrea Clinical Research Unit
Daytona Beach, Florida, 32117
Fortrea Clinical Research Unit
Madison, Wisconsin, 53704
About this study
Official title: A Dose-Escalation Phase 1, Investigator- and Participant-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Doses of LY3532226 in Participants With Obesity
The main purpose of this study is to evaluate the safety and tolerability of the study drug known as LY3532226 in participants with obesity. Blood tests will be performed to check how much LY3532226 gets into the bloodstream and how long it takes the body to eliminate it following weekly or monthly administration. Part A of the study will last approximately 16 weeks, excluding screening period. Part B of the study will last approximately 20 weeks, excluding the screening period. Part C of the study will last approximately 8 weeks, excluding the screening period.
- Conditions
- Obesity
- Being tested
- LY3532226, Placebo
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY3532226Drug
Administered SC
PlaceboDrug
Administered SC
| Study group | Role | What they receive |
|---|---|---|
| LY3532226 (Part A) | Experimental | LY3532226 administered subcutaneously (SC) Receives: Drug: LY3532226 |
| Placebo (Part A) | Placebo comparator | Placebo administered SC Receives: Drug: Placebo |
| LY3532226 (Part B) | Experimental | LY3532226 administered SC Receives: Drug: LY3532226 |
| Placebo (Part B) | Placebo comparator | Placebo administered SC Receives: Drug: Placebo |
| LY3532226 (Part C) | Experimental | LY3532226 administered SC Receives: Drug: LY3532226 |
| Placebo (Part C) | Placebo comparator | Placebo administered SC Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part A: 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 to Study Completion (Up to 16 Weeks)
Part B: 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 to Study Completion (Up to 20 Weeks)
Part 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 to Study Completion (Up to 8 Weeks)]
Secondary outcomes (5)
Part A: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3532226
PK: Cmax of LY3532226
Measured: Predose on Day 1 through Week 16
Part A: PK: Area Under the Concentration Versus Time Curve (AUC) of LY3532226
PK: AUC of LY3532226
Measured: Predose on Day 1 through Week 16
Part B: PK: Cmax of LY3532226
PK: Cmax of LY3532226
Measured: Predose on Day 1 through Week 20
Part B: PK: AUC of LY3532226
PK: AUC of LY3532226
Measured: Predose on Day 1 through Week 20
Part C: Pharmacodynamic (PD): Change in insulin sensitivity index (Si)
Part C: PD: Change in Si
Measured: Baseline up to Approximately Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2024
- Study start16 Aug 2024
- Primary completion12 Dec 2025
- Study completion12 Dec 2025
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
- 132 participants (actual)
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 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06557356
- Sponsor's protocol ID
- 18835
- Other IDs
- J2V-MC-GZLD
- Status last verified
- Jan 2026
- First submitted
- 14 Aug 2024
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dose-Escalation Phase 1, Investigator- and Participant-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Doses of LY3532226 in Participants With Obesity
- ClinicalTrials.gov ID
- NCT06557356
- Acronym / sponsor ID
- 18835
- Conditions
- Obesity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 16 Aug 2024 (actual)
- Primary completion
- 12 Dec 2025 (actual)
- Study completion
- 12 Dec 2025 (actual)
- First posted
- 16 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main purpose of this study is to evaluate the safety and tolerability of the study drug known as LY3532226 in participants with obesity. Blood tests will be performed to check how much LY3532226 gets into the bloodstream and how long it takes the body to eliminate it following weekly or monthly administration. Part A of the study will last approximately 16 weeks, excluding screening period. Part B of the study will last approximately 20 weeks, excluding the screening period. Part C of the study will last approximately 8 weeks, excluding the screening period.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| LY3532226 (Part A) | Experimental | Drug: LY3532226LY3532226 administered subcutaneously (SC) |
| Placebo (Part A) | Placebo comparator | Drug: PlaceboPlacebo administered SC |
| LY3532226 (Part B) | Experimental | Drug: LY3532226LY3532226 administered SC |
| Placebo (Part B) | Placebo comparator | Drug: PlaceboPlacebo administered SC |
| LY3532226 (Part C) | Experimental | Drug: LY3532226LY3532226 administered SC |
| Placebo (Part C) | Placebo comparator | Drug: PlaceboPlacebo administered SC |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Have a body weight not exceeding 150 kilograms (kg) or 330 pounds (lb) and body mass index (BMI) within the range of 30 to 40 kilogram per square meter (kg/m²)
- Have had a stable body weight that is less than or equal to 5% change in body weight for 3 months prior to screening and enrollment
Key exclusion criteria (7 listed)
- Have a lifetime history of a suicide attempt
- Have a history or presence of psychiatric disorders, including a history of major depressive disorder within the last 2 years
- Have a baseline Patient Health Questionnaire-9 (PHQ-9) score of 15 or greater, and/or a score of 2 or greater for either of the first 2 questions on the PHQ-9 questionnaire
- Have a known clinically significant gastric emptying abnormality, have undergone gastric bypass surgery or restrictive bariatric surgery
- Have taken approved or investigational medication for weight loss, within the previous 3 months or 5 half-lives of study screening, whichever is earlier
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LY3532226Administered SC | Drug | LY3532226 (Part A), LY3532226 (Part B), LY3532226 (Part C) |
| PlaceboAdministered SC | Drug | Placebo (Part A), Placebo (Part B), Placebo (Part C) |
Primary outcome
Part A: 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 to Study Completion (Up to 16 Weeks)
A summary of TEAEs and SAEs, regardless of causality, will be reported in the Reported Adverse Events module
Part B: 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 to Study Completion (Up to 20 Weeks)
A summary of TEAEs and SAEs, regardless of causality, will be reported in the Reported Adverse Events module
Part 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 to Study Completion (Up to 8 Weeks)]
A summary of TEAEs and SAEs, regardless of causality, will be reported in the Reported Adverse Events module
5 secondary outcomes
Part A: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3532226
Time frame: Predose on Day 1 through Week 16
Part A: PK: Area Under the Concentration Versus Time Curve (AUC) of LY3532226
Time frame: Predose on Day 1 through Week 16
Part B: PK: Cmax of LY3532226
Time frame: Predose on Day 1 through Week 20
Part B: PK: AUC of LY3532226
Time frame: Predose on Day 1 through Week 20
Part C: Pharmacodynamic (PD): Change in insulin sensitivity index (Si)
Time frame: Baseline up to Approximately Week 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2026.
- Lilly TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Obesity
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) study director
Eli Lilly and Company
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LY3532226 in people with Obesity, run by Eli Lilly and Company at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part A: 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 to Study Completion (Up to 16 Weeks)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2026.