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CompletedPhase 1

A Study of LY3532226 in Participants With Type 2 Diabetes Mellitus

A Phase 1b, 2-Part, Investigator- and Participant-Blind, Multiple-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LY3532226 in Participants With Type 2 Diabetes Mellitus

Assets

Dulaglutide / Macupatide

Listed sites

1

Recruiting sites

-

Actual enrollment

90

Study population

Type 2 diabetes

Eligibility highlights

•BMI 23-45

Primary endpoints

•Treatment-emergent AEs (any) (Treatment-emergent AEs (any), Serious AEs (any))•Part B

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT05407961
Org study ID17835
Secondary ID2021-003257-31
Secondary IDJ2V-MC-GZLBEli Lilly and Company

Timeline

Milestones

Study first posted2022-06-07actual
Study start2022-06-07actual
Primary completion2024-01-12actual
Study completion2024-01-12actual
Last update posted2024-03-29actual

Assets

Investigational agents

DulaglutideMacupatide

Who this study enrolls

Type 2 diabetes

Who can enroll

Minimum age18 Years
Maximum age70 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Participants with type 2 diabetes mellitus (T2DM) for at least 3 months before screening
•Have the following glycosylated hemoglobin (HbA1c) levels at screening:

1. HbA1c >/= 7.0% to </= 10.0% for participants treated with diet and exercise alone and participants treated with metformin alone, and

2. HbA1c >/= 6.0% to </= 9.5% for participants treated with dipeptidyl peptidase inhibitor-4 (DPP-4) (with/without metformin) inhibitors and participants treated with metformin and sodium-glucose cotransporter-2 (SGLT-2) inhibitor

•Participants treated with diet and exercise alone or on a stable dose of metformin for at least 3 months
•Participants with body weight up to 150 kilograms (kg) and body mass index (BMI) of 23.0 to 45.0 kilograms per meter squared (kg/m²)
•Male participants who agree to use effective methods of contraception and female participants not of childbearing potential

Exclusion criteria

•Participants who have uncontrolled diabetes defined as an episode of ketoacidosis or hyperosmolar state requiring hospitalization in the 6 months prior to screening
•Have a clinically significant abnormality ECG
•Have obesity induced by other endocrine disorders such as Cushing's syndrome or Prader-Willi syndrome
•Are on any glucose-lowering medications other than metformin, SGLT-2 inhibitors and/or DPP4
•Have received chronic systemic glucocorticoid therapy (>2 weeks) in the past 6 months
•Have an average weekly alcohol intake that exceeds 21 units per week (males 65 years of age or lesser) and 14 units per week (females and males 65 years of age or older)
•Smoke more than 10 cigarettes, or cigarette equivalent, per day

Endpoints (10)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Glycemic / diabetes
7
Safety / tolerability / PK
3

Glycemic / diabetes

7 endpoints
Primary/protocol endpoint

Part B: Change from Baseline in Total Clamp Disposition Index (cDI)

Time frame:Baseline up to Week 12

change from baseline, improvement

Secondary/protocol endpoint

Part B: Change from Baseline in Insulin Secretion Rate (ISR) from hyperglycaemic clamp

Time frame:Baseline through Week 12

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Part B: Change from Baseline in β-cell Glucose Sensitivity (GS) from hyperglycaemic clamp

Time frame:Baseline through Week 12

change from baseline, improvement

Secondary/protocol endpoint

Part B: Change from Baseline in Hyperinsulinemic Euglycemic Clamp M-value

Time frame:Baseline through Week 12

change from baseline, improvement

Secondary/protocol endpoint

Part A & B: Change from Baseline in Fasting and Post meal Glucose during Standardized Mixed-meal Tolerance Test (sMMTT)

Time frame:Baseline through Week 16

Postprandial glucose

change from baseline, improvement

componentsFasting glucose, change, Postprandial glucose

Secondary/protocol endpoint

Part A & B: Change from Baseline in Glycosylated Haemoglobin (HbA1c)

Time frame:Baseline through Week 16

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Part A & B: Change from Baseline in Glucagon Concentration at Fasting and Post meal during sMMTT

Time frame:Baseline through Week 16

change from baseline, improvement

Safety / tolerability / PK

3 endpoints
Primary/protocol endpoint

Part A: Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration

Time frame:Baseline up to Week 16

Treatment-emergent AEs (any)

event count, event

componentsTreatment-emergent AEs (any), Serious AEs (any)

Secondary/protocol endpoint

Part A: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3532226

Time frame:Predose on Day 1 through Week 16

Cmax

concentration, descriptive

Secondary/protocol endpoint

Part A: PK: Area Under the Concentration Versus Time Curve (AUC) of LY3532226

Time frame:Predose on Day 1 through Week 16

AUC₀-∞

concentration, descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 6, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 6, 2026 snapshot.