A Study to Find Out if the Study Drug Elecoglipron Helps Adults With Type 2 Diabetes Mellitus by Comparing it With Semaglutide, a Medicine Already Used to Treat Type 2 Diabetes Mellitus

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorAstraZeneca

About this trial

The purpose of this study is to evaluate the efficacy, safety, and tolerability of elecoglipron compared with oral semaglutide in adults with T2DM and increased cardiovascular risk that is inadequately managed alone or on stable treatment with other background glucose-lowering medication(s).

Eligibility criteria

Qualifiers

Diagnosed with Type 2 Diabetes Mellitus (T2DM) for at least 90 days prior to screening

T2DM inadequately managed with lifestyle management alone or on stable treatment with other background glucose-lowering medication(s)

HbA1c value of ≥ 7% to ≤ 10.5% (53 to 91.3 mmol/mol)

Increased risk of cardiovascular (CV) events defined by ≥1 of: documented coronary heart disease, peripheral arterial disease, ischemic cerebrovascular disease, or heart failure (NYHA II-III); or ≥2 CV risk factors

Disqualifiers

Type 1 Diabetes Mellitus (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 Gastrointestinal (GI) tract or chronic use of any medication that affects gastric motility or gastric emptying

Trial design

Treatments tested in this trial

  • Elecoglipron
  • Semaglutide

Treatment groups

1,200 Participants
are divided into 2 treatment groups

Sponsors and collaborators