Trial · Interventional
CompletedPhase 1Registry dataA Study to Investigate the Response of Participants With Type 2 Diabetes Mellitus on Once-Weekly Retatrutide to Hypoglycemia
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
- Ph 1
A Study to Investigate the Response of Participants With Type 2 Diabetes Mellitus on Once-Weekly Retatrutide to Hypoglycemia
NCT069828466 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.
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)
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.
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.
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.
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
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