Recruiting
A Phase III Study to Investigate the Efficacy and Safety of Elecoglipron Compared With Placebo in Adults With Type 2 Diabetes Mellitus on Background Insulin
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), treated with a background insulin and other background glucose-lowering medication(s)
ClinicalTrials.gov IDNCT07664553
PhasePHASE3
Enrollment600
SponsorAstraZeneca
Age18 Years
SexALL
Conditions studied
Type 2 Diabetes Mellitus
About this study
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), treated with a background insulin and other background glucose-lowering medication(s)
Interventions
- Drug: Elecoglipron — Elecoglipron is administered orally once daily.
- Drug: Placebo — Placebo is administered orally once daily.
Primary outcomes
- Change from baseline in Hemoglobin A1c (HbA1c) (Baseline to Week 40)
Eligibility information
Inclusion Criteria:
* Diagnosed with T2DM for at least 90 days prior to screening
* Stable treatment with background insulin and other background glucose-lowering medication(s)
* HbA1c value of ≥ 7% to ≤ 10.5%
* 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:
* T1DM, 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 (NYHA IV)
* History/family history of medullary thyroid cancer or multiple endocrine neoplasia type 2
Study locations
- Research Site, Little Rock, Arkansas 72205 United States
- Research Site, Sacramento, California 95821 United States
- Research Site, Aurora, Colorado 80045 United States
- Research Site, DeLand, Florida 32720 United States
- Research Site, Doral, Florida 33166 United States
- Research Site, Ocoee, Florida 34761 United States
- Research Site, Decatur, Georgia 30030 United States
- Research Site, Potomac, Maryland 20854 United States
- Research Site, Brooklyn, New York 11220 United States
- Research Site, Cary, North Carolina 27518 United States
Showing 10 of 132 reported sites. See the official listing for all locations.
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.