Current partner codePEPTIDESDE
NCT07662213·Phase 3·INTERVENTIONAL

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

Status

Recruiting

Phase

Phase 3

Enrollment

1,200

Locations

201

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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

Treatment arms and agents.

DRUG

Elecoglipron

Elecoglipron is administered orally once daily.

DRUG

Semaglutide

Semaglutide is administered orally once daily.

Timeline

From registration to results.

  1. First posted

    Jun 23, 2026

  2. Study start

    Jul 6, 2026

  3. Primary completion

    May 23, 2028

  4. Study completion

    May 23, 2028

  5. Results posted

    Not reported

  6. Registry updated

    Jul 14, 2026

Outcomes

What the study measures.

Primary outcomes

Change from baseline in Hemoglobin A1c (HbA1c)

Time frame · Baseline to Week 52

Secondary outcomes

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

Who can take part.

Minimum age
18 Years
Maximum age
Not reported
Sex
ALL
Healthy volunteers
No

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

201 registered sites.

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

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Semaglutide.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.