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Trial · Interventional

CompletedPhase 1Registry data

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

NCTNCT06982846 (opens ClinicalTrials.gov in a new tab)Other id27316Other idJ1I-MC-GZQFOther id2024-518471-63-00

Overview

Status
Completed
Phase
Phase 1
Enrollment
80 participants (actual)
Sponsor
Eli Lilly and Company · Industry
Design
Randomized · Double masking
Countries
1 country

Austria

Start
6 Jun 2025
Primary completion
4 May 2026
Completion
4 May 2026
First posted
21 May 2025
Last update posted
18 Jun 2026
Conditions
Type 2 Diabetes Mellitus

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
202520262027
  1. Ph 1

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

    NCT06982846

    6 Jun 2025 to 4 May 2026

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

  • RetatrutideDrug
  • PlaceboDrug

Arms2

  • Experimental

    Retatrutide

    Participants will receive escalated doses of retatrutide administered subcutaneously (SC) every week (QW) until reaching target dose.

  • Placebo comparator

    Placebo

    Participants will receive matching placebo administered SC QW.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. 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

    Registry description

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

Secondary outcomes(4)
  1. 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

    Registry description

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

  2. 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

    Registry description

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

  3. Hypoglycemic Symptoms Score at set PG Concentration Points

    Time frame · Day 114 during hypoglycemic clamp

    Registry description

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

  4. Percentage of Participants Who Experienced Hypoglycemic Awareness at Set PG Points

    Time frame · Day 114 during hypoglycemic clamp

    Registry description

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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 70 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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.

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