Clinical trial

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

Recruiting now · Phase 3 · 6 countries · Registry ID NCT07662213

Recruiting nowPhase 3Interventional

What this study is about

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).

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed
SexAll
Healthy volunteersNot accepted
ConditionType 2 Diabetes Mellitus

Full registry criteria

Inclusion Criteria: * 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 * 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 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 * 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

Treatments and study arms

Elecoglipron

Drug

Elecoglipron is administered orally once daily.

Semaglutide

Drug

Semaglutide is administered orally once daily.

Primary outcomes

Change from baseline in Hemoglobin A1c (HbA1c)Baseline to Week 52

Study locations

201 locations were listed when this page was built. The first 40 are shown.

Research Site🇦🇷 Buenos Aires, Argentina
Research Site🇦🇷 CABA, Argentina
Research Site🇦🇷 Caba, Argentina
Research Site🇦🇷 Ciudad de Buenos Aires, Argentina
Research Site🇦🇷 Rosario, Argentina
Research Site🇦🇷 San Nicolás, Argentina
Research Site🇦🇷 San Vicente, Argentina
Research Site🇦🇺 Botany, Australia
Research Site🇦🇺 East Toowoomba, Australia
Research Site🇦🇺 Fitzroy, Australia
Research Site🇦🇺 Heidelberg Heights, Australia
Research Site🇦🇺 Kingswood, Australia
Research Site🇦🇺 Melbourne, Australia
Research Site🇦🇺 Parkville, Australia
Research Site🇦🇺 St Leonards, Australia
Research Site🇧🇷 Brasília, Brazil
Research Site🇧🇷 Campinas, Brazil
Research Site🇧🇷 Curitiba, Brazil
Research Site🇧🇷 Natal, Brazil
Research Site🇧🇷 Porto Alegre, Brazil
Research Site🇧🇷 São José dos Campos, Brazil
Research Site🇧🇷 São Paulo, Brazil
Research Site🌐 Plovdiv, Bulgaria
Research Site🌐 Sofia, Bulgaria
Research Site🌐 Sofia, Bulgaria
Research Site🌐 Sofia, Bulgaria
Research Site🌐 Yambol, Bulgaria
Research Site🇨🇦 Guelph, Ontario, Canada
Research Site🇨🇦 Montreal, Quebec, Canada
Research Site🇨🇦 Saint-Charles-Borromée, Quebec, Canada
Research Site🇨🇦 Sarnia, Ontario, Canada
Research Site🇨🇦 Scarborough Village, Ontario, Canada
Research Site🇨🇦 Stouffville, Ontario, Canada
Research Site🇨🇦 Toronto, Ontario, Canada
Research Site🇨🇦 Toronto, Ontario, Canada
Research Site🇨🇦 Toronto, Ontario, Canada
Research Site🇨🇦 Vancouver, British Columbia, Canada
Research Site🇨🇳 Changsha, China
Research Site🇨🇳 Changsha, China
Research Site🇨🇳 Hefei, China