ObesityPhase 1NCT07765511

A Study of Macupatide (LY3532226) in Participants With Obesity or Overweight Without Type 2 Diabetes

A Phase 1 study testing Macupatide and Eloralintide in people with Obesity and Overweight, run by Eli Lilly and Company at 3 sites in Japan.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

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Trial summary

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Obesity, Overweight
What is being tested?: Macupatide and Eloralintide
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 60 participants
Where: 3 sitesJapan
Study dates: Oct 2026to Jun 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

Are Japanese participants assigned male at birth (AMAB) or assigned female at birth (AFAB) who agree to contraception requirements or participants who are individuals not of childbearing potential (INOCBP).
Have a body mass index greater than or equal to (≥)25 kilograms per square meter (kg/m²)
Have had a stable weight for the 3 months prior to screening. Stable weight is defined as less than 5 percent (%) body weight change.

Who cannot join

Have known allergies to related compounds of macupatide or eloralintide, or any components of the formulations.
Have a history of significant atopy, including severe allergic manifestations, or clinically significant multiple or severe drug allergies, or severe posttreatment hypersensitivity reactions.
Have a history or presence of psychiatric disorders, including a history of major depressive disorder or severe psychiatric disorders, within the last 3 years, that would present a safety risk or may significantly impair the participant's ability to comply with study procedures.
Have been diagnosed with Type 1 or Type 2 diabetes mellitus.
Have a history of chronic medical conditions involving the heart, liver, or kidneys.
Have a history of any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years.

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Have a history or presence of a gastrointestinal (GI) disorder or previous surgery that impacts gastric emptying.
Have had or plan to have during the study, a device-based or surgical treatment use for obesity.
Have been treated, or plan to be treated, with prescription medications or other non approved drugs intended to promote weight loss, within 3 months prior to screening.
Are currently enrolled or have participated, within the last 30 days, in a clinical study involving an investigational product. If the previous investigational product has a long half-life, 5 half-lives or 30 days, whichever is longer, should have passed.
Have previously completed or withdrawn from this study or have previously received macupatide or eloralintide.
Have evidence of acute or chronic liver disease or pancreatic disease.

Trial locations and contacts

3 sites in 1 country. 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

1-317-615-4559

LillyTrials@Lilly.com

Physicians interested in becoming principal investigators please contact contact

clinical_inquiry_hub@lilly.com

Japan3 sites

Souseikai Fukuoka Mirai Hospital
Fukuoka, 813-0017
81120023812
Misato Nakagawa
Sumida Hospital
Sumida-ku, 130-0004
81120023812
Takuma Yonemura
Medical Corporation Houeikai Sekino Clinical Pharmacology Clinic
Toshima City, 171-0014
81120023812
Takashi Nakamura

Other trials in Japan

About this study

Official title: A Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Macupatide Monotherapy, and Macupatide in Combination With Eloralintide, in Japanese Participants With Obesity or Overweight Without Type 2 Diabetes.

The main purpose of this study is to assess how well macupatide, when dosed alone and in combination with eloralintide, is tolerated and what side effects may occur in participants with obesity or overweight without Type 2 diabetes. Blood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body. For each participant, the study will last about 4 months and will include 2 stays in the Clinical Research Unit (CRU), each lasting 3-5 nights.

Conditions: Obesity, Overweight
Being tested: Macupatide, Eloralintide, 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.

MacupatideDrug
Also called LY3532226
Administered SC
EloralintideDrug
Administered SC
PlaceboDrug
Administered SC

Study groups in NCT07765511
Study group	Role	What they receive
Macupatide ＋ placebo	Experimental	Macupatide and placebo administered subcutaneously (SC) Receives: Drug: Macupatide; Drug: Placebo
Eloralintide + placebo	Experimental	Eloralintide and placebo administered SC Receives: Drug: Eloralintide; Drug: Placebo
Macupatide Dose A + Eloralintide	Experimental	Macupatide and Eloralintide administered SC Receives: Drug: Macupatide; Drug: Eloralintide
Macupatide Dose B + Eloralintide	Experimental	Macupatide and Eloralintide administered SC Receives: Drug: Macupatide; Drug: Eloralintide
Placebo	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 Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Measured: End of Study (Week 25)

Secondary outcomes (5)

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Macupatide
Measured: Baseline through Week 25
PK: AUC of Macupatide in Combination with Eloralintide
Measured: Baseline through Week 25
PK: Maximum Concentration (Cmax) of Macupatide
Measured: Baseline through Week 25
PK: Cmax of Macupatide in Combination with Eloralintide
Measured: Baseline through Week 25
Percent Change in Body Weight
Measured: Baseline through Week 25

Timeline

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

Oct 2026Jun 2027

First posted14 Aug 2026
Study startOct 2026 (estimated)
Primary completionJun 2027 (estimated)
Study completionJun 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: 60 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07765511
Sponsor's protocol ID: 27505
Other IDs: J2V-JE-GZLE
Status last verified: Aug 2026
First submitted: 11 Aug 2026
Last updated: 14 Aug 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Interested in taking part?

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

1-317-615-4559

LillyTrials@Lilly.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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