Elecoglipron vs placebo for adults with type 2 diabetes and impaired kidney function on dapagliflozin

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 3 trial compares elecoglipron to placebo in adults with type 2 diabetes and impaired renal function who are on background dapagliflozin therapy or are SGLT2i-naïve, along with other glucose-lowering meds. Participants must have type 2 diabetes for at least 90 days, a BMI of 23 or higher, and stable weight, with specific HbA1c ranges depending on SGLT2i exposure. The study aims to assess efficacy, safety, and tolerability over a defined treatment period. Key exclusion criteria include type 1 diabetes, history of ketoacidosis, significant GI conditions, and recent severe hypoglycemia. The trial is sponsored by AstraZeneca and will enroll at sites in Sun City, AZ; Surprise, AZ; and Concord, CA.

Why it matters

Who can join: the full rules

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

Where it's running

• Research Site
  Sacramento, California, United States Recruiting
• Research Site
  Miami Lakes, Florida, United States Recruiting
• Research Site
  Ocoee, Florida, United States Recruiting
• Research Site
  Kansas City, Missouri, United States Recruiting
• Research Site
  Albuquerque, New Mexico, United States Recruiting
• Research Site
  Raleigh, North Carolina, United States Recruiting

+136 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: AstraZeneca Clinical Study Information Center
• Email: information.center@astrazeneca.com
• Phone: 1-877-240-9479

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.