Active not recruitingPhase 1

A Study to Investigate the Response of Participants With Type 2 Diabetes Mellitus on Once-Weekly Retatrutide to Hypoglycemia

A Randomized, Placebo-Controlled, Parallel Study to Investigate the Response of Participants With Type 2 Diabetes Mellitus on Once-Weekly Retatrutide to Hypoglycemia

Lead sponsor

Eli Lilly and Company

Asset

Retatrutide

Subcutaneous · GLP-1 / GIP / glucagon triple

Listed sites

Recruiting sites

Estimated enrollment

Study population

Type 2 diabetes

Eligibility highlights

•BMI 25-45

Primary endpoint

•Time-to-Event of Recovery of Plasma Glucose (PG) Concentration from 48 Milligram

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 IDNCT06982846

Org study ID27316

Secondary ID2024-518471-63-00

Secondary IDJ1I-MC-GZQFEli Lilly and Company

Timeline

Milestones

Study first posted2025-05-21actual

Study start2025-06-06actual

Last update posted2026-01-20actual

Primary completion2026-05estimated (month precision)

Study completion2026-05estimated (month precision)

Assets

Investigational agents

Retatrutide

Who this study enrolls

Type 2 diabetes

Who can enroll

Minimum age18 Years

Maximum age70 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Have been diagnosed with T2DM for at least 6 months prior to screening.

•Treated with diet and exercise and stable treatment with metformin with or without 1 additional allowed oral antihyperglycemic medications (OAM), 3 months prior to screening.

-Treatment with metformin will be considered stable if all prescribed total daily doses for this period were ±850 mg from the original prescription for the same participant.

-Allowed OAMs include dipeptidyl peptidase-4 (DPP-IV) inhibitors, sodium-glucose co-transporter-2 (SGLT2) inhibitors, glinides, or sulfonylureas.

•Have a hemoglobin A1c value at screening of

-≥6.0% (≥ 42 millimole per liter(mmol/L)) and ≤9.5% (≤80 mmol/L) if on metformin only or

-≥6.0% (≥42 mmol/L) and ≤8.5% (≤69 mmol/L) if on metformin in combination with 1 additional allowed OAM.

•Have a BMI within the range 25.0 kg/m2 and 45.0 kg/m2 kg/m2 (both inclusive).

•Have had a stable body weight that is less than 5% change in body weight for more than 3 months prior to screening.

Exclusion criteria

•Have Type 1 diabetes mellitus.

•Have had more than 1 episode of severe hypoglycemia, as defined by the American Diabetes Association criteria, within 6 months before screening or has a history of hypoglycemia unawareness or poor recognition of hypoglycemic symptoms.

•Have had 1 or more episodes of ketoacidosis or hyperosmolar state/coma requiring hospitalization within the 6 months prior to screening.

•Have impaired renal estimated glomerular filtration rate <60 mL/min/1.73 m2 calculated by Chronic Kidney Disease-Epidemiology.

•Have acute or chronic pancreatitis or a history of acute idiopathic pancreatitis.

•Have elevations in

-serum aspartate aminotransferase (AST) >2.5× upper limit normal (ULN)

-serum alanine aminotransferase (ALT) >2.5×ULN

-total bilirubin level (TBL) >1.5×ULN, or

-alkaline phosphatase (ALP) level ≥1.5× ULN.

•Have a known clinically significant gastric emptying abnormality.

Endpoints (5)

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.

Safety / tolerability / PK

5 endpoints

Primary/protocol endpoint

Time-to-Event of Recovery of Plasma Glucose (PG) Concentration from 48 Milligram per Deciliter (48 mg/dL) to 70 mg/dL (tPG_nadir-70 mg/dL)

Time frame:Within 60 minutes after nadir

time to event, event

Secondary/protocol endpoint

Time to Reach Recovery of Plasma Glucose (PG) Concentration from 48 mg/dL to 70 mg/dL (tPG_nadir-70 mg/dL) Including Recovery Beyond 60 Minutes.

Time frame:Beyond 60 minutes after nadir

time to event, event

Secondary/protocol endpoint

Percentage of Participants Who Require Rescue Glucose Infusion to Attain Recovery PG Concentration of 70 mg/dL

Time frame:Up to 60 minutes after nadir

threshold achievement, event

Secondary/protocol endpoint

Hypoglycemic Symptoms Score at set PG Concentration Points

Time frame:Day 114 during hypoglycemic clamp

descriptive

Secondary/protocol endpoint

Percentage of Participants Who Experienced Hypoglycemic Awareness at Set PG Points

Time frame:Day 114 during hypoglycemic clamp

threshold achievement, event

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.