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NCT Number: NCT07765511

A Study of Macupatide (LY3532226) in 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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Souseikai Fukuoka Mirai Hospital, Fukuoka, Japan

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.
  • 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.

Treatment and study plan

Macupatide

Drug

Administered SC

Other names: LY3532226

Eloralintide

Drug

Administered SC

Placebo

Drug

Administered SC

Primary outcomes

  1. 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)

Secondary outcomes

  1. Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Macupatide

    Time frame: Baseline through Week 25

  2. PK: AUC of Macupatide in Combination with Eloralintide

    Time frame: Baseline through Week 25

  3. PK: Maximum Concentration (Cmax) of Macupatide

    Time frame: Baseline through Week 25

  4. PK: Cmax of Macupatide in Combination with Eloralintide

    Time frame: Baseline through Week 25

  5. Percent Change in Body Weight

    Time frame: Baseline through Week 25

Study contacts

Contact information is provided by the study sponsor or research team.

Physicians interested in becoming principal investigators please contact

CONTACT

[email protected]

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

CONTACT

[email protected]

1-317-615-4559

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study 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.

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 14, 2026
Registry last updated
Aug 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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