- A Phase III Study to Investigate the Efficacy and Safety of Elecoglipron Compared With Placebo in Adults With Type 2 Diabetes Mellitus and Impaired Renal Function on Background Dapagliflozin — Recruiting • Phase III • Diabetes / Metabolic • NCT07662135.
- Being tested: Elecoglipron (a novel therapeutic agent) versus placebo in patients with type 2 diabetes who have impaired renal function, all receiving background dapagliflozin therapy, to assess efficacy, safety, and tolerability.
- Patient eligibility overview: Adults with established type 2 diabetes mellitus and concurrent impaired renal function who are either currently on or initiating dapagliflozin treatment are eligible for this Phase III investigation.
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
The purpose of this study is to evaluate the efficacy, safety, and tolerability of elecoglipron, compared with placebo in adults with type 2 diabetes mellitus (T2DM) and impaired renal function, who are or will be on a background of sodium-glucose cotransporter 2 inhibitor (SGLT2i) dapagliflozin 10 mg as per guideline directed medical therapy (GDMT) for chronic kidney disease (CKD). Additionally, participants are on other glucose-lowering medication(s).
- : * Diagnosed with Type 2 Diabetes Mellitus for at least 90 days prior to screening * On SGTL2i or SGLT2i-naïve and other glucose lowering medication(s) * HbA1c value: 1. On stable dose of SGLT2i ≥ 7.0 % to ≤ 10.5% (53 to 91.3 mmol/mol) 2. SGLT2i-naive ≥ 7.5% to ≤ 10.5% (58 to 91.3 mmol/mol) * Impaired renal function * Body mass index (BMI) of ≥ 23 kg/m2 at screening * Stable body weight (self-reported or documented) for 90 days prior to screening
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.