DRUG
Elecoglipron
Elecoglipron is administered orally once daily.
Status
Recruiting
Phase
Phase 3
Enrollment
1,200
Locations
201
Results
Not posted
Publications
0
Study 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).
Interventions
DRUG
Elecoglipron is administered orally once daily.
DRUG
Semaglutide is administered orally once daily.
Timeline
First posted
Jun 23, 2026
Study start
Jul 6, 2026
Primary completion
May 23, 2028
Study completion
May 23, 2028
Results posted
Not reported
Registry updated
Jul 14, 2026
Outcomes
Change from baseline in Hemoglobin A1c (HbA1c)
Time frame · Baseline to Week 52
Percent change from baseline to Week 52 in body weight
Time frame · Baseline to Week 52
Change from baseline to Week 52 in body weight (kg)
Time frame · Baseline to Week 52
Achieved ≥ 5% weight loss from baseline at Week 52 and achieved HbA1c < 7% (53 mmol/mol) at Week 52
Time frame · Baseline to Week 52
Achieved HbA1c ≤ 6.5% (48 mmol/mol) at Week 52
Time frame · Week 52
Achieved HbA1c < 7% (53 mmol/mol) at Week 52
Time frame · Week 52
Achieved ≥ 5% weight loss from baseline at Week 52
Time frame · Baseline to Week 52
Change from baseline to Week 52 in Systolic Blood Pressure (BP) and Diastolic BP
Time frame · Baseline to Week 52
Eligibility
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
Study locations
Argentina · Australia · Brazil · Bulgaria · Canada · China · Germany · Hungary · Italy · Japan · Poland · South Korea · Taiwan · United Kingdom · United States. Showing up to 24 locations stored in the fast local snapshot.
Research Site
Birmingham, Alabama, United States
Research Site
Mesa, Arizona, United States
Research Site
Phoenix, Arizona, United States
Research Site
Tempe, Arizona, United States
Research Site
Covina, California, United States
Research Site
Encinitas, California, United States
Research Site
Garden Grove, California, United States
Research Site
Loma Linda, California, United States
Research Site
Long Beach, California, United States
Research Site
Pomona, California, United States
Research Site
Sacramento, California, United States
Research Site
Bridgeport, Connecticut, United States
Research Site
Crystal River, Florida, United States
Research Site
Hollywood, Florida, United States
Research Site
Jacksonville, Florida, United States
Research Site
Leesburg, Florida, United States
Research Site
Orlando, Florida, United States
Research Site
Lilburn, Georgia, United States
Research Site
Idaho Falls, Idaho, United States
Research Site
Melrose Park, Illinois, United States
Research Site
Evansville, Indiana, United States
Research Site
Ames, Iowa, United States
Research Site
Wichita, Kansas, United States
Research Site
Bowling Green, Kentucky, United States
Publications
No PMID-linked publications were present in this registry snapshot.
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Related PeptideStat pages
Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.