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Clinical Trials in the UK / NCT07667803
Recruiting Phase 3

A Master Protocol to Investigate Efficacy and Safety of Elecoglipron in Participants With Obesity or Overweight With or Without T2DM

NCT07667803 · tracked via the Priya Life Science UK tracker
Sponsor
AstraZeneca
Phase
Phase 3
Started
2026-06-29
Last updated
2026-09-09

Condition(s) studied

Weight Management

Investigational drug(s) / intervention(s)

ElecoglipronPlacebo

Elecoglipron: Elecoglipron film-coated tablet once daily

Placebo: Placebo matching elecoglipron film-coated tablet once daily

Study 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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (325)

FacilityCityRegionStatus
Research Site Birmingham Alabama Not Yet Recruiting
Research Site Dothan Alabama Recruiting
Research Site Chandler Arizona Recruiting
Research Site Sun City Arizona Not Yet Recruiting
Research Site Little Rock Arkansas Recruiting
Research Site Lynwood California Recruiting
Research Site Rolling Hills Estates California Not Yet Recruiting
Research Site Sacramento California Recruiting
Research Site Arvada Colorado Recruiting
Research Site New Haven Connecticut Not Yet Recruiting
Research Site Plantation Florida Not Yet Recruiting
Research Site Tampa Florida Recruiting
Research Site Woodstock Georgia Recruiting
Research Site Ammon Idaho Recruiting
Research Site Melrose Park Illinois Not Yet Recruiting
Research Site Indianapolis Indiana Not Yet Recruiting
Research Site Wichita Kansas Not Yet Recruiting
Research Site Louisville Kentucky Recruiting
Research Site Alexandria Louisiana Recruiting
Research Site Baltimore Maryland Not Yet Recruiting
Research Site Potomac Maryland Recruiting
Research Site White Marsh Maryland Recruiting
Research Site Ypsilanti Michigan Withdrawn
Research Site Ridgeland Mississippi Not Yet Recruiting
Research Site Kansas City Missouri Recruiting
Research Site St Louis Missouri Not Yet Recruiting
Research Site Reno Nevada Not Yet Recruiting
Research Site Albuquerque New Mexico Not Yet Recruiting
Research Site Albany New York Not Yet Recruiting
Research Site Laurelton New York Recruiting
Research Site Long Island City New York Recruiting
Research Site Greensboro North Carolina Recruiting
Research Site Raleigh North Carolina Recruiting
Research Site Rocky Mount North Carolina Not Yet Recruiting
Research Site Statesville North Carolina Recruiting
Research Site Columbus Ohio Recruiting
Research Site Dayton Ohio Recruiting
Research Site Oklahoma City Oklahoma Not Yet Recruiting
Research Site Tulsa Oklahoma Recruiting
Research Site Portland Oregon Not Yet Recruiting

+ 285 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07667803 on ClinicalTrials.gov ↗ ← All trials in the UK