Recruiting
Phase 3

Elecoglipron

Sponsor:

AstraZeneca

Code:

NCT07667803

Conditions

Weight Management

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Elecoglipron

Placebo

Study Details

Brief summary:

This master study protocol, Study D7260C00015, covers 2 independent, pivotal studies, Study 1 and Study 2. Each study is a global, randomized, double-blind, parallel-group, multicenter, Phase III study to assess the efficacy and safety of elecoglipron compared with placebo adjunct to diet and exercise for weight management, in adults living with obesity or overweight with at least one weight-related comorbidity, and without T2DM (Study 1) or with T2DM (Study 2).

Conditions

Weight Management

Study ID

NCT07667803

Start date

Jun 29, 2026

Status verified date

Sep, 2026

Completion date

Jul 30, 2029

Anticipated

Primary completion date

Jul 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria

  • Legal age of consent and at least 18 years old
  • Study 1 -

  • BMI ≥ 30 kg/m2 or
  • 25 kg/m2 ≤ BMI < 30 kg/m2 with at least one of the following weight-related comorbidities:
  • Hypertension
  • Prediabetes
  • Dyslipidemia
  • Cardiovascular disease
  • Obstructive sleep apnea.
  • Study 2 - BMI ≥ 25 kg/m2 and T2DM defined as below:

  • Established diagnosis of T2DM
  • Without established diagnosis of T2DM and HbA1c ≥ 6.5% (48 mmol/mol) at the screening visit
  • Stable body weight (self-reported or documented) for 90 days prior to the screening visit (± 5% body weight change)
  • History of at least one self-reported unsuccessful dietary effort to lose body weight.

Exclusion Criteria

  • Study 1 - Established diagnosis of T1DM or T2DM.
  • Study 2 - Any of the following medical history, laboratory values, or complications related to diabetes:

  • T1DM
  • HbA1c ≥ 10% (86 mmol/mol) at the screening visit
  • 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 the screening visit, or has a history of hypoglycemia unawareness or poor recognition of hypoglycemic symptoms
  • History of acute (unless due to previously resolved gallstone pancreatitis and post-cholecystectomy) or chronic pancreatitis
  • History/family history (first degree biologic relatives) of medullary thyroid cancer or multiple endocrine neoplasia type 2

Study Design

Enrollment

4500 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Arm 1 - Dose 1

Active IMP

experimental: Arm 2 - Dose 2

Active IMP

placebo comparator: Arm 3 - Placebo

Placebo matching elecoglipron

Interventions

Elecoglipron

Elecoglipron film-coated tablet once daily

Placebo

Placebo matching elecoglipron film-coated tablet once daily

Primary outcome measure

  • Percent body weight loss [ Time Frame: 72 weeks ]

Central Contacts and Locations

Central contacts

AstraZeneca Clinical Study Information Center

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

Locations

Research Site

Recruiting

Dothan, Alabama, United States, 36305

Research Site

Recruiting

Chandler, Arizona, United States, 85225

Research Site

Recruiting

Little Rock, Arkansas, United States, 72205

Research Site

Recruiting

Lynwood, California, United States, 90262

Research Site

Recruiting

Sacramento, California, United States, 95821

Research Site

Recruiting

Arvada, Colorado, United States, 80002

Research Site

Recruiting

Tampa, Florida, United States, 33606

Research Site

Recruiting

Woodstock, Georgia, United States, 30189

Research Site

Recruiting

Ammon, Idaho, United States, 83406

Research Site

Recruiting

Louisville, Kentucky, United States, 40213

Research Site

Recruiting

Alexandria, Louisiana, United States, 71303

Research Site

Recruiting

Potomac, Maryland, United States, 20854

Research Site

Recruiting

White Marsh, Maryland, United States, 21162

Research Site

Recruiting

Kansas City, Missouri, United States, 64114

Research Site

Recruiting

Laurelton, New York, United States, 11413

Research Site

Recruiting

Long Island City, New York, United States, 11106

Research Site

Recruiting

Greensboro, North Carolina, United States, 27408

Research Site

Recruiting

Raleigh, North Carolina, United States, 27609

Research Site

Recruiting

Statesville, North Carolina, United States, 28625

Research Site

Recruiting

Columbus, Ohio, United States, 43228

Research Site

Recruiting

Dayton, Ohio, United States, 45424

Research Site

Recruiting

Tulsa, Oklahoma, United States, 74133

Research Site

Recruiting

DuBois, Pennsylvania, United States, 15801

Research Site

Recruiting

Charleston, South Carolina, United States, 29407

Research Site

Recruiting

Gaffney, South Carolina, United States, 29340

Research Site

Recruiting

Dallas, Texas, United States, 75254

Research Site

Recruiting

Irving, Texas, United States, 75063

Research Site

Recruiting

Calgary, Alberta, Canada, T3R 1W9

Research Site

Recruiting

Vancouver, British Columbia, Canada, V5Y 3W2

Research Site

Recruiting

Victoria, British Columbia, Canada, V8V 4A1

Research Site

Recruiting

Moncton, New Brunswick, Canada, E1G 1A7

Research Site

Recruiting

Truro, Nova Scotia, Canada, B2N 1L2

Research Site

Recruiting

Brampton, Ontario, Canada, L6T 0G1

Research Site

Recruiting

Hamilton, Ontario, Canada, L8L 5G8

Research Site

Recruiting

Niagara Falls, Ontario, Canada, L2H 1H5

Research Site

Recruiting

North York, Ontario, Canada, M6B 3H7

Research Site

Recruiting

Sarnia, Ontario, Canada, N7T 4X3

Research Site

Recruiting

Scarborough Village, Ontario, Canada, M1R 0B1

Research Site

Recruiting

Stouffville, Ontario, Canada, L4A1H2

Research Site

Recruiting

Toronto, Ontario, Canada, M3J 0K2

Research Site

Recruiting

Toronto, Ontario, Canada, M6G 1M2

Research Site

Recruiting

Toronto, Ontario, Canada, M9V 4B4

Research Site

Recruiting

Joliette, Quebec, Canada, J6E 6A9

Research Site

Recruiting

Montreal, Quebec, Canada, H4N 2W2

Research Site

Recruiting

Saint-Lambert, Quebec, Canada, J4P 1S9

Research Site

Recruiting

Terrebonne, Quebec, Canada, J6X 4P7

More Information

Sponsor

AstraZeneca

Last update posted

Sep 9, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by AstraZeneca on 2026-09-09.