NCT06982846CompletedPhase 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
Source: ClinicalTrials.gov · Last updated 18 Jun 2026
Brief summary (registry, in English)
The purpose of this study is to measure the effect of retatrutide versus placebo, administered every week, on time to recovery from hypoglycemia during hypoglycemic clamp in participants with Type 2 Diabetes Mellitus (T2DM) following 16 weeks of treatment.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 80 (actual)
- First submitted
- 14 May 2025
- Start date
- 6 Jun 2025
- Primary completion date
- 4 May 2026
- Lead sponsor
- Eli Lilly and Company
- Diseases
- Type 2 diabetes
- NCT number
- NCT06982846
- EU CT number
- 2024-518471-63-00
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 80
- From 6 Jun 2025 to the primary completion date, 4 May 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- Have Type 1 diabetes mellitus.
- 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.
Lab values
- 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.
Other
- Have a known clinically significant gastric emptying abnormality.
Who the study is looking for
- 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.
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Medical University of Graz Coordinator of this site? Confirm its status | Graz | Austria | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.