OverweightPhase 1NCT06606106
A Study of LY3537031 in Overweight, Obese, and Healthy Participants
A Phase 1 study testing LY3537031 in people with Overweight and Obesity, run by Eli Lilly and Company at 5 sites in United States.
Trial summary
This is a 4-part study that includes a Part A, Part B, Part C, and Part D. Parts A and D will study the safety and tolerability of the study drug known as LY3537031 in participants who are overweight and obese. Part B and Part C will study the safety and tolerability of LY3537031 in healthy participants. Read more about this study
- Who is it for?
- Ages 22 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight, Obesity
- What is being tested?
- LY3537031
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 302 participants
- Where
- 5 sitesUnited States
- Study dates
- 5 Sep 2024to Nov 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 22 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Have a BMI within the range of:
- Parts A and D: 27.0 to 45.0 kilogram per square meter (kg/m²)
- Parts B and C: 22.0 to 26.9 kg/m²
- Parts B and C: Weigh 60 kg (80 pounds (lbs)) or more at screening
- Have no significant (not more than 5%) self-reported weight gain or loss in the past 3 months prior to screening
- Have a thyroid stimulating hormone (TSH) value within normal local laboratory ranges.
Who cannot join
- Have undergone any form of bariatric surgery
- Participants who are lactating
- Have taken medications that promote weight loss within 90 days before screening
- Have a serum calcitonin level (at screening) of greater than or equal to 35 nanograms per liter (ng/L) (35 picograms per milliliter (pg/mL), 10.2 picomoles per liter (pmol/L))
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Fortrea Clinical Research Unit
Dallas, Texas, 75247
Fortrea Clinical Research Unit
Daytona Beach, Florida, 32117
Collaborative Neuroscience Research, LLC
Los Alamitos, California, 90720
Clinical Pharmacology of Miami
Miami, Florida, 33172
QPS
Springfield, Missouri, 65802
About this study
Official title: A Multiple-Ascending Dose Study to Investigate the Safety, Pharmacokinetics, and Pharmacodynamics of LY3537031 in Overweight and Obese Participants and Healthy Volunteers
This is a 4-part study that includes a Part A, Part B, Part C, and Part D. Parts A and D will study the safety and tolerability of the study drug known as LY3537031 in participants who are overweight and obese. Part B and Part C will study the safety and tolerability of LY3537031 in healthy participants. Part C will contain only Japanese and Chinese healthy participants.
Blood tests will be performed to check how much LY3537031 gets into the bloodstream and how long it takes the body to eliminate it. Body weight will be measured. The study will last approximately 49 weeks excluding a screening period.
- Conditions
- Overweight, Obesity
- Being tested
- LY3537031, Placebo
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY3537031Drug
Administered SC
PlaceboDrug
Administered SC
| Study group | Role | What they receive |
|---|---|---|
| LY3537031 Part A (Cohorts 1-7) | Experimental | Multiple-ascending doses of LY3537031 administered subcutaneously (SC) Receives: Drug: LY3537031 |
| Placebo Part A | Placebo comparator | Placebo administered SC Receives: Drug: Placebo |
| LY3537031 Part B (Cohorts 8-11) | Experimental | Multiple-ascending doses of LY3537031 administered SC Receives: Drug: LY3537031 |
| Placebo Part B | Placebo comparator | Placebo administered SC Receives: Drug: Placebo |
| LY3537031 Part C (Cohorts 12-15) | Experimental | Multiple-ascending doses of LY3537031 administered SC Receives: Drug: LY3537031 |
| Placebo Part C | Placebo comparator | Placebo administered SC Receives: Drug: Placebo |
| LY3537031 Part D (Cohorts 16-19) | Experimental | Multiple-ascending doses of LY3537031 administered SC Receives: Drug: LY3537031 |
| Placebo Part D | 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.
Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs), Serious Adverse Event(s) (SAEs), and Adverse Event(s) (AEs) Considered by the Investigator to be Related to Study Drug Administration
A summary of TEAEs, SAEs, and AEs regardless of causality, will be reported in the Reported Adverse Events module
Measured: Baseline to Study Completion (Up to 56 Weeks)
Secondary outcomes (11)
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3537031
Measured: Predose on Day 1 through Week 56
PK: Area Under the Concentration Versus Time Curve (AUC) of LY3537031
Measured: Predose on Day 1 through Week 56
Pharmacodynamic (PD): Change from Baseline in Body Weight
Measured: Baseline up to Week 56
PD: Change from Baseline in Fasting Glucose
Measured: Baseline up to Week 56
PD: Change from Baseline in Oral Glucose Tolerance Test (OGTT) Results
Measured: Baseline up to Week 56
PD: Change from Baseline in AUC of Glucose
Measured: Baseline Up to Week 56
PD: Change from Baseline in Insulin Levels
Measured: Baseline Up to Week 56
PD: Change from Baseline in Connecting Peptide (C-peptide) Levels
Measured: Baseline Up to Week 56
PD: Change from Baseline in Cmax of Acetaminophen to Assess the Delay in Gastric Emptying
Measured: Baseline up to Week 56
PD: Change from Baseline in AUC of Acetaminophen to Assess the Delay in Gastric Emptying
Measured: Baseline Up to Week 56
PD: Change from Baseline in Time to Peak Drug Concentration (Tmax) of Acetaminophen to Assess the Delay in Gastric Emptying
Measured: Baseline Up to Week 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2024
- Study start5 Sep 2024
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies 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
- 302 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
- NCT06606106
- Sponsor's protocol ID
- 27199
- Other IDs
- J2S-MC-GZMD
- Status last verified
- Sep 2026
- First submitted
- 27 Aug 2024
- Last updated
- 30 Sep 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 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multiple-Ascending Dose Study to Investigate the Safety, Pharmacokinetics, and Pharmacodynamics of LY3537031 in Overweight and Obese Participants and Healthy Volunteers
- ClinicalTrials.gov ID
- NCT06606106
- Acronym / sponsor ID
- 27199
- Conditions
- Overweight, Obesity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 302 participants (estimated)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 5 Sep 2024 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 20 Sep 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.
This is a 4-part study that includes a Part A, Part B, Part C, and Part D. Parts A and D will study the safety and tolerability of the study drug known as LY3537031 in participants who are overweight and obese. Part B and Part C will study the safety and tolerability of LY3537031 in healthy participants. Part C will contain only Japanese and Chinese healthy participants.
Blood tests will be performed to check how much LY3537031 gets into the bloodstream and how long it takes the body to eliminate it. Body weight will be measured. The study will last approximately 49 weeks excluding a screening period.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| LY3537031 Part A (Cohorts 1-7) | Experimental | Drug: LY3537031Multiple-ascending doses of LY3537031 administered subcutaneously (SC) |
| Placebo Part A | Placebo comparator | Drug: PlaceboPlacebo administered SC |
| LY3537031 Part B (Cohorts 8-11) | Experimental | Drug: LY3537031Multiple-ascending doses of LY3537031 administered SC |
| Placebo Part B | Placebo comparator | Drug: PlaceboPlacebo administered SC |
| LY3537031 Part C (Cohorts 12-15) | Experimental | Drug: LY3537031Multiple-ascending doses of LY3537031 administered SC |
| Placebo Part C | Placebo comparator | Drug: PlaceboPlacebo administered SC |
| LY3537031 Part D (Cohorts 16-19) | Experimental | Drug: LY3537031Multiple-ascending doses of LY3537031 administered SC |
| Placebo Part D | Placebo comparator | Drug: PlaceboPlacebo administered SC |
Who may qualify
- Ages
- 22 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Have a BMI within the range of:
- Parts B and C: Weigh 60 kg (80 pounds (lbs)) or more at screening
- Have no significant (not more than 5%) self-reported weight gain or loss in the past 3 months prior to screening
- Have a thyroid stimulating hormone (TSH) value within normal local laboratory ranges.
Key exclusion criteria (4 listed)
- Have undergone any form of bariatric surgery
- Participants who are lactating
- Have taken medications that promote weight loss within 90 days before screening
- Have a serum calcitonin level (at screening) of greater than or equal to 35 nanograms per liter (ng/L) (35 picograms per milliliter (pg/mL), 10.2 picomoles per liter (pmol/L))
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 |
|---|---|---|
| LY3537031Administered SC | Drug | LY3537031 Part A (Cohorts 1-7), LY3537031 Part B (Cohorts 8-11), LY3537031 Part C (Cohorts 12-15), LY3537031 Part D (Cohorts 16-19) |
| PlaceboAdministered SC | Drug | Placebo Part A, Placebo Part B, Placebo Part C, Placebo Part D |
Primary outcome
Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs), Serious Adverse Event(s) (SAEs), and Adverse Event(s) (AEs) Considered by the Investigator to be Related to Study Drug Administration
Time frame: Baseline to Study Completion (Up to 56 Weeks)
A summary of TEAEs, SAEs, and AEs regardless of causality, will be reported in the Reported Adverse Events module
11 secondary outcomes
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3537031
Time frame: Predose on Day 1 through Week 56
PK: Area Under the Concentration Versus Time Curve (AUC) of LY3537031
Time frame: Predose on Day 1 through Week 56
Pharmacodynamic (PD): Change from Baseline in Body Weight
Time frame: Baseline up to Week 56
PD: Change from Baseline in Fasting Glucose
Time frame: Baseline up to Week 56
PD: Change from Baseline in Oral Glucose Tolerance Test (OGTT) Results
Time frame: Baseline up to Week 56
PD: Change from Baseline in AUC of Glucose
Time frame: Baseline Up to Week 56
PD: Change from Baseline in Insulin Levels
Time frame: Baseline Up to Week 56
PD: Change from Baseline in Connecting Peptide (C-peptide) Levels
Time frame: Baseline Up to Week 56
PD: Change from Baseline in Cmax of Acetaminophen to Assess the Delay in Gastric Emptying
Time frame: Baseline up to Week 56
PD: Change from Baseline in AUC of Acetaminophen to Assess the Delay in Gastric Emptying
Time frame: Baseline Up to Week 56
PD: Change from Baseline in Time to Peak Drug Concentration (Tmax) of Acetaminophen to Assess the Delay in Gastric Emptying
Time frame: Baseline Up to Week 56
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- A Study of LY3537031 in Overweight, Obese, and Healthy ParticipantsLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Overweight
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 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST) study director
Eli Lilly and Company
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LY3537031 in people with Overweight and Obesity, run by Eli Lilly and Company at 5 sites in United States.
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 6 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. 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?
This study is still under way. Results are not available in the source record yet.
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?
Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs), Serious Adverse Event(s) (SAEs), and Adverse Event(s) (AEs) Considered by the Investigator to be Related to Study Drug Administration (time frame: Baseline to Study Completion (Up to 56 Weeks)). 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 30 Sep 2026.