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RecruitingPhase 3

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

AstraZeneca · NCT07667803

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Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 3
Target enrollment
4500
US sites recruiting
44
Study start
June 29, 2026
Record last updated
October 13, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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).

Being studied: Elecoglipron; Placebo

Conditions: Weight Management

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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

Recruiting US locations

Study contacts (from the official record)

  • AstraZeneca Clinical Study Information Center · 1-877-240-9479 · information.center@astrazeneca.com
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A Master Protocol to Investigate Efficacy and Safety of… (NCT07667803) | Bored Studies