Recruiting

Phase 3

Elecoglipron vs. SemaglutideA 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

Sponsor:

AstraZeneca

Code:

NCT07662213

Conditions

Type 2 Diabetes Mellitus

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Elecoglipron

Semaglutide

Study Details

Brief 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

Type 2 Diabetes Mellitus

Study ID

NCT07662213

Start date

Jul 6, 2026

Status verified date

Oct, 2026

Completion date

May 23, 2028

Anticipated

Primary completion date

May 23, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

1200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Elecoglipron

Participants will receive elecoglipron dose XX mg administered orally once daily.

active comparator: Semaglutide

Participants will receive semaglutide dose XX mg administered orally once daily.

Interventions

Elecoglipron

Elecoglipron is administered orally once daily.

Semaglutide

Semaglutide is administered orally once daily.

Primary outcome measure

Change from baseline in Hemoglobin A1c (HbA1c) [ Time Frame: Baseline to Week 52 ]

Central Contacts and Locations

Central contacts

AstraZeneca Clinical Study Information Center

1-877-240-9479 information.center@astrazeneca.com

Locations

Research Site

Recruiting

Phoenix, Arizona, United States, 85016

Research Site

Recruiting

Encinitas, California, United States, 92024

Research Site

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Pomona, California, United States, 91768

Research Site

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Sacramento, California, United States, 95821

Research Site

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Lake City, Florida, United States, 32055

Research Site

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Leesburg, Florida, United States, 34748

Research Site

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Ames, Iowa, United States, 50010

Research Site

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Rockville, Maryland, United States, 20852

Research Site

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Henderson, Nevada, United States, 89052

Research Site

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Morehead City, North Carolina, United States, 28557

Research Site

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Wilmington, North Carolina, United States, 28403

Research Site

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Houston, Texas, United States, 77004

Research Site

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Sugar Land, Texas, United States, 77478

Research Site

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Vancouver, British Columbia, Canada, V5Y 3W2

Research Site

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Guelph, Ontario, Canada, N1H 1B1

Research Site

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Sarnia, Ontario, Canada, N7T 4X3

Research Site

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Scarborough Village, Ontario, Canada, M1R 0B1

Research Site

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Stouffville, Ontario, Canada, L4A1H2

Research Site

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Toronto, Ontario, Canada, M4G3E8

Research Site

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Toronto, Ontario, Canada, M6G 1M2

Research Site

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Toronto, Ontario, Canada, M9V 4B4

Research Site

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Montreal, Quebec, Canada, H4N 2W2

Research Site

Recruiting

Saint-Charles-Borromée, Quebec, Canada, J6E 2B4

More Information

Sponsor

AstraZeneca

Last update posted

Oct 22, 2026

Last verified

Oct, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-24. This information was provided to ClinicalTrials.gov by AstraZeneca on 2026-10-22. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.