Current partner codePEPTIDESDE
NCT06982846·Phase 1·INTERVENTIONAL

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

Status

Completed

Phase

Phase 1

Enrollment

80

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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.

Interventions

Treatment arms and agents.

DRUG

Retatrutide

Administered SC

DRUG

Placebo

Administered SC

Timeline

From registration to results.

  1. First posted

    May 21, 2025

  2. Study start

    Jun 6, 2025

  3. Primary completion

    May 4, 2026

  4. Study completion

    May 4, 2026

  5. Results posted

    Not reported

  6. Registry updated

    Jun 18, 2026

Outcomes

What the study measures.

Primary outcomes

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 of recovery of PG concentration from 48 mg/dL to 70 mg/dL.

Secondary outcomes

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 of recovery of PG concentration from 48 mg/dL to 70 mg/dL including recovery beyond 60 minutes.

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

Percentage of participants who require rescue glucose infusion to attain recovery PG concentration of 70 mg/dL.

Hypoglycemic Symptoms Score at set PG Concentration Points

Time frame · Day 114 during hypoglycemic clamp

Hypoglycemia symptoms were measured with the Edinburgh Hypoglycemia Symptom Scale (EHSS) where lower scores indicate fewer symptoms.

Percentage of Participants Who Experienced Hypoglycemic Awareness at Set PG Points

Time frame · Day 114 during hypoglycemic clamp

Percentage of participants who experienced hypoglycemic awareness at set PG points.

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
70 Years
Sex
ALL
Healthy volunteers
No

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.

Study locations

1 registered sites.

Austria. Showing up to 24 locations stored in the fast local snapshot.

Medizinische Universität Graz

Graz, Austria

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Retatrutide.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.