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
NCT07662213 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1200
Last updated 2026-07-14
Summary
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).
Conditions
Interventions
- DRUG
-
Elecoglipron
Elecoglipron is administered orally once daily.
- DRUG
-
Semaglutide is administered orally once daily.
Sponsors & Collaborators
- lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-07-06
- Primary Completion
- 2028-05-23
- Completion
- 2028-05-23
- FDA Drug
- Yes
Countries
- United States
- Argentina
- Australia
- Brazil
- Bulgaria
- Canada
- China
- Germany
- Hungary
- Italy
- Japan
- Poland
- South Korea
- Taiwan
- United Kingdom
Study Locations
More Related Trials
-
30 Week Parallel Group Comparison Study of Linagliptin + Pioglitazone (5+15, 5+30 and 5+45 mg) qd Versus Respective Monotherapies, Followed by a Comparison of 5mg+30mg and 5mg+45mg Versus Respective Monotherapies in Type 2 Diabetes for up to 54 Weeks
NCT01183013 ·Status: COMPLETED ·Phase: PHASE3
-
Comparison Study of the Glycemic Effects, Safety, and Tolerability of Exenatide Once Weekly Suspension to Sitagliptin and Placebo in Subjects With Type 2 Diabetes Mellitus
NCT01652729 ·Status: COMPLETED ·Phase: PHASE3
-
Efficacy and Safety of Empagliflozin (BI 10773) / Linagliptin (BI 1356) Fixed Dose Combination in Treatment naïve and Metformin Treated Type 2 Diabetes Patients
NCT01422876 ·Status: COMPLETED ·Phase: PHASE3
-
Research Study to Compare Semaglutide Tablets With Empagliflozin or Metformin Tablets in People With Type 2 Diabetes
NCT06083675 ·Status: WITHDRAWN ·Phase: PHASE3
-
Efficacy and Safety of Liraglutide Versus Lixisenatide as add-on to Metformin in Subjects With Type 2 Diabetes
NCT01973231 ·Status: COMPLETED ·Phase: PHASE4
-
Comparison of the Effect of Exenatide Versus Sitagliptin on 24-hour Average Glucose in Patients With Type 2 Diabetes on Metformin or a Thiazolidinedione
NCT00729326 ·Status: COMPLETED ·Phase: PHASE4
-
Evaluate Efficacy and Safety of Saxagliptin in Combination With Metformin in Adult Patients With Type 2 Diabetes
NCT00661362 ·Status: COMPLETED ·Phase: PHASE3
-
Effect of Liraglutide on Blood Glucose Control in Subjects With Type 2 Diabetes
NCT00333151 ·Status: COMPLETED ·Phase: PHASE3
-
Linagliptin Versus Placebo in Type 2 Diabetic Patients With Inadequate Glycaemic Control on Metformin in Combination With Pioglitazone
NCT00996658 ·Status: COMPLETED ·Phase: PHASE3
-
Safety and Efficacy of Linagliptin (BI 1356) Plus Metformin in Type 2 Diabetes, Factorial Design
NCT00798161 ·Status: COMPLETED ·Phase: PHASE3
-
18-week add-on to Metformin Comparison of Saxagliptin and Sitagliptin in Adult Patients With Type 2 Diabetes (T2D)
NCT00666458 ·Status: COMPLETED ·Phase: PHASE3
-
Safety and Efficacy in Type 2 Diabetic Patients With Severe Chronic Renal Impairment, 5 mg BI 1356 (Linagliptin) vs. Placebo, Insulin Background Inclusive
NCT00800683 ·Status: COMPLETED ·Phase: PHASE3
-
A Study to Compare a New Drug for Type 2 Diabetes to Placebo and to a Treatment Already Available for Type 2 Diabetes
NCT02119819 ·Status: COMPLETED ·Phase: PHASE2
-
A Study in Participants With Type 2 Diabetes Mellitus (AWARD-2)
NCT01075282 ·Status: COMPLETED ·Phase: PHASE3
-
The Effect of Liraglutide Compared to Sitagliptin, Both in Combination With Metformin on Glycaemic Control in Subjects With Type 2 Diabetes Mellitus
NCT00700817 ·Status: COMPLETED ·Phase: PHASE3
-
A Trial Comparing Insulin Degludec/Liraglutide and Insulin Degludec in Combination With Metformin in Chinese Subjects With Type 2 Diabetes Mellitus Inadequately Controlled With Basal Insulin Therapy and Metformin With or Without One Other Oral Antidiabetic Drug (OAD)
NCT03175120 ·Status: COMPLETED ·Phase: PHASE3
-
Safety and Efficacy of Linagliptin (BI 1356) as Monotherapy or in Combination in Type 2 DM
NCT00736099 ·Status: COMPLETED ·Phase: PHASE3
-
Comparison of Two Treatment Regimens (Sitagliptin Versus Liraglutide) on Participants Who Failed to Achieve Good Glucose Control on Metformin Alone (MK-0431-403)
NCT01296412 ·Status: COMPLETED ·Phase: PHASE3
-
A Study in Participants With Type 2 Diabetes Mellitus
NCT01064687 ·Status: COMPLETED ·Phase: PHASE3
-
Study Assessing Saxagliptin Treatment In Type 2 Diabetic Subjects Who Are Not Controlled With Metformin Alone
NCT00121667 ·Status: COMPLETED ·Phase: PHASE3
-
Safety and Efficacy of Exenatide in Patients With Type 2 Diabetes Using Thiazolidinediones or Thiazolidinediones and Metformin
NCT00099320 ·Status: COMPLETED ·Phase: PHASE3
-
Efficacy and Safety of Empagliflozin (BI 10773) With Metformin in Patients With Type 2 Diabetes
NCT01167881 ·Status: COMPLETED ·Phase: PHASE3
-
A Study to Compare the Effects of Exenatide and Sitagliptin on Postprandial Glucose in Subjects With Type 2 Diabetes Mellitus
NCT00477581 ·Status: COMPLETED ·Phase: PHASE4
-
A Study to Compare the Glycemic Effects, Safety, and Tolerability of Exenatide Once Weekly to Those of Sitagliptin and Pioglitazone,in Subjects With Type 2 Diabetes Treated With Metformin (DURATION - 2)
NCT00637273 ·Status: COMPLETED ·Phase: PHASE3
-
Safety and Efficacy Study of Alogliptin on Glycemic Control in Subjects With Type 2 Diabetes.
NCT00755846 ·Status: COMPLETED ·Phase: PHASE2