NCT07662135 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
| NCT ID | NCT07662135 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | AstraZeneca |
| Condition | Type 2 Diabetes Mellitus |
| Study Type | INTERVENTIONAL |
| Enrollment | 900 participants |
| Start Date | 2026-07-06 |
| Primary Completion | 2028-07-13 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 900 participants in total. It began in 2026-07-06 with a primary completion date of 2028-07-13.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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).
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Type 1 Diabetes, secondary forms of diabetes (including congenital forms), or history of ketoacidosis or hyperosmolar coma * Currently receiving or anticipated to receive, therapeutic intervention for diabetic retinopathy and/or macular edema * Have had more than one episode of severe hypoglycemia within 180 days prior to screening or has a history of hypoglycemia unawareness or poor recognition of hypoglycemic symptoms * Clinically significant condition affecting the upper GI tract or chronic use of any medication that affects gastric motility or gastric emptying * History of acute or chronic pancreatitis * Severe congestive heart failure (New York Heart Association IV) * History/family history of medullary thyroid cancer or multiple endocrine neoplasia type 2
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07662135 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Type 2 Diabetes Mellitus. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07662135 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 900 participants.
Is NCT07662135 currently recruiting?
Yes, NCT07662135 is actively recruiting participants. Contact the research team at information.center@astrazeneca.com for enrollment information.
Where is the NCT07662135 trial being conducted?
This trial is being conducted at Peoria, United States, Surprise, United States, Concord, United States, Sacramento, United States and 11 additional locations.
Who is sponsoring the NCT07662135 clinical trial?
NCT07662135 is sponsored by AstraZeneca. The trial plans to enroll 900 participants.
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