IRB Study Number 24-388
Status Recruiting
Phase Phase 3
Location Cleveland Clinic Main Campus
Institute Endocrinology and Metabolism Institute
Description
The purpose of this study is to investigate the efficacy and safety of retatrutide 4 mg, 9 mg, or 12 mg administered once weekly (QW) for 52 weeks compared with placebo for mean change from baseline in HbA1c in participants with T2D with inadequate glycemic control and moderate or severe renal impairment treated with insulin glargine alone or a combination of insulin glargine with or without metformin and/or SGLT2 inhibitor.
This study will consist of 3 periods:
a screening period: up to 35 days
a treatment period: 52 weeks, including dose escalation and maintenance, and
a safety follow-up period: 4 weeks.
Inclusion Criteria
Participant must be at least 18 years of age or the legal age of consent in the jurisdiction in which the study is taking place at the time of signing the informed consent
Have a clinical diagnosis of T2D
Have HbA1c ≥7.0% (53 mmol/mol) to ≤10.5% (91 mmol/mol),
Have moderate or severe renal impairment
Have been on the following stable diabetes treatment
Are motivated and willing to make themselves available for the duration of the study and are able to follow study procedures as required
Have a normal wake/sleep cycle such that midnight to 0600 hours will reliably reflect a usual sleeping period.
