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

NCT07765511 | Not Yet Recruiting Phase 1

• 2 other identifiers: 27505J2V-JE-GZLE
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 3

Brief 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. 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

Outcome Measures

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

  End of Study (Week 25)

Secondary Outcomes (5)

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

  Baseline through Week 25

• PK: AUC of Macupatide in Combination with Eloralintide

  Baseline through Week 25

• PK: Maximum Concentration (Cmax) of Macupatide

  Baseline through Week 25

• PK: Cmax of Macupatide in Combination with Eloralintide

  Baseline through Week 25

• Percent Change in Body Weight

  Baseline through Week 25

Study Arms (5)

Macupatide ＋ placebo

EXPERIMENTAL

Macupatide and placebo administered subcutaneously (SC)

Drug: Macupatide; Drug: Placebo

Eloralintide + placebo

EXPERIMENTAL

Eloralintide and placebo administered SC

Drug: Eloralintide; Drug: Placebo

Macupatide Dose A + Eloralintide

EXPERIMENTAL

Macupatide and Eloralintide administered SC

Drug: Macupatide; Drug: Eloralintide

Macupatide Dose B + Eloralintide

EXPERIMENTAL

Macupatide and Eloralintide administered SC

Drug: Macupatide; Drug: Eloralintide

Placebo

PLACEBO COMPARATOR

Placebo administered SC

Drug: Placebo

Interventions

Macupatide DRUG

Administered SC

Also known as: LY3532226

Macupatide Dose A + Eloralintide; Macupatide Dose B + Eloralintide; Macupatide ＋ placebo

Eloralintide DRUG

Administered SC

Eloralintide + placebo; Macupatide Dose A + Eloralintide; Macupatide Dose B + Eloralintide

Placebo DRUG

Administered SC

Eloralintide + placebo; Macupatide ＋ placebo; Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (3)

Souseikai Fukuoka Mirai Hospital

Fukuoka, 813-0017, Japan

Location

Sumida Hospital

Sumida-ku, 130-0004, Japan

Location

Medical Corporation Houeikai Sekino Clinical Pharmacology Clinic

Toshima City, 171-0014, Japan

Location

MeSH Terms

Conditions

Obesity; Overweight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• 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)

  Eli Lilly and Company

  STUDY DIRECTOR

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2026
• First Posted: August 14, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: August 14, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

JP (3)