A Study to Investigate the Response of Participants With Type 2 Diabetes Mellitus on Once-Weekly Retatrutide to Hypoglycemia
NCT ID: NCT06982846
Last Updated: 2025-12-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
78 participants
INTERVENTIONAL
2025-06-06
2026-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Retatrutide
Participants will receive escalated doses of retatrutide administered subcutaneously (SC) every week (QW) until reaching target dose.
Retatrutide
Administered SC
Placebo
Participants will receive matching placebo administered SC QW.
Placebo
Administered SC
Interventions
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Retatrutide
Administered SC
Placebo
Administered SC
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
70 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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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)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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Medizinische Universität Graz
Graz, , Austria
Countries
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Central Contacts
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Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
Role: CONTACT
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Role: CONTACT
Facility Contacts
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Role: primary
Other Identifiers
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J1I-MC-GZQF
Identifier Type: OTHER
Identifier Source: secondary_id
2024-518471-63-00
Identifier Type: CTIS
Identifier Source: secondary_id
27316
Identifier Type: -
Identifier Source: org_study_id
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