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Elecoglipron for Weight Management in Obesity or Overweight

This study is testing a new medication called elecoglipron, taken as a pill once a day, to see if it helps with weight management. It's for adults aged 18 and older who are living with obesity (very overweight) or are overweight with at least one weight-related health issue like high blood pressure, prediabetes, or sleep apnea. Some participants will receive elecoglipron, while others will receive a placebo (a pill with no active medicine). The main goal is to see how much body weight is lost after 72 weeks (about 1.5 years). The study aims to enroll 4500 people.

Study design
This is a Phase III, global, randomized, double-blind study, meaning participants are randomly assigned to receive either elecoglipron or a placebo, and neither you nor your doctor will know which you are receiving. It involves about 4500 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured at 72 weeks, indicating participants will be followed for at least that long.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07667803

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

Recruiting
PHASE3Ages 18+InterventionalTreatment
AstraZeneca
~4,500 participants
Updated 2026-07-10 on ClinicalTrials.gov
What's tested:ElecoglipronPlacebo

At a glance

Recruiting sites
5 of 321 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percent body weight loss
Measured over 72 weeks

Conditions

Weight Management

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Cardiovascular DisorderDyslipidemiaHypertensionMultiple Endocrine Neoplasia Type 2ObesityObstructive Sleep ApneaOverweightPancreatitisPrediabetesThyroid Gland Medullary CarcinomaType 1 Diabetes MellitusType 2 Diabetes Mellitus

Where it's being run

321 sites across 57 states
China46
Germany22
Japan17
India16
Poland16
Spain15
United Kingdom15
Argentina12

Study leadership

  • Prof. Melanie Davies, MBChB · PRINCIPAL_INVESTIGATOR · Diabetes Research Centre Leicester Diabetes Centre - Bloom University of Leicester
  • Dr. Ania Jastreboff, MD, PhD · PRINCIPAL_INVESTIGATOR · Yale University

Who to contact

AstraZeneca Clinical Study Information Center
[email protected]
1-877-240-9479
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Percent body weight loss72 weeks

    Percent change from baseline to Week 72 in body weight