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.
Trial summary
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. 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?
- 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
- 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 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
Physicians interested in becoming principal investigators please contact contact
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
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 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.
- 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)
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
- 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
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT07765511
- Acronym / sponsor ID
- 27505
- Conditions
- Obesity, Overweight
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Oct 2026 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 14 Aug 2026 (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 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Macupatide ＋ placebo | Experimental | Drug: Macupatide, Drug: PlaceboMacupatide and placebo administered subcutaneously (SC) |
| Eloralintide + placebo | Experimental | Drug: Eloralintide, Drug: PlaceboEloralintide and placebo administered SC |
| Macupatide Dose A + Eloralintide | Experimental | Drug: Macupatide, Drug: EloralintideMacupatide and Eloralintide administered SC |
| Macupatide Dose B + Eloralintide | Experimental | Drug: Macupatide, Drug: EloralintideMacupatide and Eloralintide administered SC |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo administered SC |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
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 |
|---|---|---|
| MacupatideAlso: LY3532226Administered SC | Drug | Macupatide Dose A + Eloralintide, Macupatide Dose B + Eloralintide, Macupatide ＋ placebo |
| EloralintideAdministered SC | Drug | Eloralintide + placebo, Macupatide Dose A + Eloralintide, Macupatide Dose B + Eloralintide |
| PlaceboAdministered SC | Drug | Eloralintide + placebo, Macupatide ＋ placebo, Placebo |
Primary outcome
Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Time frame: End of Study (Week 25)
5 secondary outcomes
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Macupatide
Time frame: Baseline through Week 25
PK: AUC of Macupatide in Combination with Eloralintide
Time frame: Baseline through Week 25
PK: Maximum Concentration (Cmax) of Macupatide
Time frame: Baseline through Week 25
PK: Cmax of Macupatide in Combination with Eloralintide
Time frame: Baseline through Week 25
Percent Change in Body Weight
Time frame: Baseline through Week 25
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 14 Aug 2026.
- Individual participant dataSharing planned: No
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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.
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or contact
Physicians interested in becoming principal investigators please contact contact
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
3 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 Macupatide and Eloralintide in people with Obesity and Overweight, run by Eli Lilly and Company at 3 sites in Japan.
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 12 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: opening soon, as of the sponsor's last update on 14 Aug 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 Japan. 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?
Contact Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or (1-317-615-4559, LillyTrials@Lilly.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration (time frame: End of Study (Week 25)). 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 14 Aug 2026.