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

Sponsor
Eli Lilly and Company
Study ID
NCT06982846
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Retatrutide — DRUG
    Administered SC
  • Placebo — DRUG
    Administered SC

Study Details

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.

Key Dates

Start date
Jun 6, 2025
Status verified
Jun 2026
Primary completion
May 4, 2026
Completion
May 4, 2026

Study Design

Enrollment
80 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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 Outcome Measure

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 ]

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