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ObesityPhase 1NCT07476118

A Study of Brenipatide (LY3537031) in Healthy Participants With Overweight or Obesity

A Phase 1 study testing Brenipatide in people with Obesity and Overweight, run by Eli Lilly and Company at 3 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The main purpose of this study is to evaluate how different dose levels of brenipatide work and how safe they are in healthy people with overweight or obesity. The study will assess the effects of different doses given as subcutaneous (under the skin) injections. Participation in this study will last about 42 weeks. 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?
Brenipatide
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
150 participants
Where
3 sitesUnited States
Study dates
18 Mar 2026to Feb 2027
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 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, as determined by medical evaluation
  • Have a BMI within the range of 27.0 to 45.0 kilogram per square meter (kg/m^2)
  • Have no significant (not more than 5 percent [%]) self-reported weight gain or loss in the past 3 months prior to screening

Who cannot join

  • Have significant history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal (GI), endocrine, hematological, dermatological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination; constituting a risk when taking the Investigational Medical Product (IMP); or interfering with the interpretation of data
  • Have a prior diagnosis of type 1 or type 2 diabetes mellitus
  • Have a history of acute or chronic pancreatitis
  • Have a personal or family history of medullary thyroid carcinoma or have multiple endocrine neoplasia syndrome type 2
  • Have received a glucagon-like peptide-1 (GLP-1) receptor agonist, glucose-dependent insulinotropic polypeptide (GIP)/GLP-1 receptor agonist, GIP/GLP-1/glucagon receptor agonist, or amylin receptor agonist within 6 months prior to screening
  • Have been treated with prescription and over-the-counter medications, or alternative remedies (including herbal/nutritional supplements), that promote weight loss within 6 months prior to screening
  • Are pregnant or lactating

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Fortrea Clinical Research Unit

    Dallas, Texas, 75247

  • Fortrea Clinical Research Unit - Daytona Beach

    Daytona Beach, Florida, 32117-5116

  • Fortrea Clinical Research Unit Inc. - Madison

    Madison, Wisconsin, 53704

Other trials in United States

About this study

Official title: A Phase 1b, Randomized, Investigator- and Participant-Blinded, Placebo-Controlled Multiple-Dose Study to Evaluate the Pharmacodynamics, Safety, Tolerability, and Pharmacokinetics of Brenipatide in Healthy Participants With Overweight or Obesity

The main purpose of this study is to evaluate how different dose levels of brenipatide work and how safe they are in healthy people with overweight or obesity. The study will assess the effects of different doses given as subcutaneous (under the skin) injections. Participation in this study will last about 42 weeks.

Conditions
Obesity, Overweight
Being tested
Brenipatide, 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.

  • BrenipatideDrug

    Also called LY3537031

    Administered SC.

  • PlaceboOther

    Administered SC.

Study groups in NCT07476118
Study groupRoleWhat they receive
BrenipatideExperimentalParticipants will receive brenipatide subcutaneously (SC).
Receives: Drug: Brenipatide
PlaceboPlacebo comparatorParticipants will receive placebo administered SC.
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percent Change in Body Weight

    Measured: Week 1, Week 29

Secondary outcomes (10)

  1. Number of Participants who discontinued due to an Adverse Events (AEs)

    Measured: Day 1 through Week 37

  2. Percentage of Participants Discontinuing Treatment due to Gastrointestinal (GI) AEs

    Measured: Day 1 through Week 37

  3. Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Brenipatide

    Measured: Pre-dose on Day 1 through Week 37

  4. PK: Maximum Concentration (Cmax) of Brenipatide

    Measured: Pre-dose on Day 1 through Week 37

  5. Percentage of Participants Achieving ≥ 5% Reduction in Body Weight

    Measured: Week 29

  6. Change in Waist Circumference

    Measured: Week 1, Week 29

  7. Change in Waist-to-Height Ratio

    Measured: Week 1, Week 29

  8. Change in Blood Pressure

    Measured: Week 1, Week 29

  9. Change in Fasting Low-density Lipoprotein- Cholesterol (LDL-C)

    Measured: Week 1, Week 29

  10. Change in High-sensitive C-reactive Protein (hsCRP)

    Measured: Week 1, Week 29

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Mar 2026
  2. Study start18 Mar 2026
  3. Primary completionFeb 2027 (estimated)
  4. Study completionFeb 2027 (estimated)

Resources

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
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07476118
Sponsor's protocol ID
27802
Other IDs
J2S-MC-GZMU
Status last verified
Jul 2026
First submitted
13 Mar 2026
Last updated
16 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Brenipatide in people with Obesity and Overweight, run by Eli Lilly and Company at 3 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 3 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: under way, not looking for participants, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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?

Percent Change in Body Weight (time frame: Week 1, Week 29). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07476118.

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 16 Jul 2026.

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