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

RecruitingPhase 3

A Phase III Randomized, Double-blind, Placebo-controlled Multicenter Master Protocol to Evaluate the Efficacy and Safety of Elecoglipron in Participants With Obesity or Overweight With or Without Type 2 Diabetes Mellitus (Embold)

Who can join

Ages 18 and older · All sexes

Full eligibility 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

About the study

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).

What is being tested

Sponsor: AstraZeneca · Participants: 4,500 · Started: Jun 29, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT07667803

Locations in the U.S.

AlabamaResearch Site, Birmingham (Not yet recruiting)
Research Site, Dothan
ArizonaResearch Site, Chandler
Research Site, Sun City (Not yet recruiting)
ArkansasResearch Site, Little Rock
CaliforniaResearch Site, Lynwood
Research Site, Rolling Hills Estates (Not yet recruiting)
Research Site, Sacramento
ColoradoResearch Site, Arvada
ConnecticutResearch Site, New Haven (Not yet recruiting)
FloridaResearch Site, Plantation (Not yet recruiting)
Research Site, Tampa
GeorgiaResearch Site, Woodstock
IdahoResearch Site, Ammon
IllinoisResearch Site, Melrose Park (Not yet recruiting)
IndianaResearch Site, Indianapolis (Not yet recruiting)
KansasResearch Site, Wichita (Not yet recruiting)
KentuckyResearch Site, Louisville
LouisianaResearch Site, Alexandria
MarylandResearch Site, Baltimore (Not yet recruiting)
Research Site, Potomac
Research Site, White Marsh
MississippiResearch Site, Ridgeland (Not yet recruiting)
MissouriResearch Site, Kansas City
Research Site, St Louis (Not yet recruiting)
NevadaResearch Site, Reno (Not yet recruiting)
New MexicoResearch Site, Albuquerque (Not yet recruiting)
New YorkResearch Site, Albany (Not yet recruiting)
Research Site, Laurelton
Research Site, Long Island City
North CarolinaResearch Site, Greensboro
Research Site, Raleigh
Research Site, Rocky Mount (Not yet recruiting)
Research Site, Statesville
OhioResearch Site, Columbus
Research Site, Dayton
OklahomaResearch Site, Oklahoma City (Not yet recruiting)
Research Site, Tulsa
OregonResearch Site, Portland (Not yet recruiting)
PennsylvaniaResearch Site, DuBois
Research Site, Newport (Not yet recruiting)
Research Site, Philadelphia (Not yet recruiting)
Rhode IslandResearch Site, East Providence (Not yet recruiting)
South CarolinaResearch Site, Charleston
Research Site, Gaffney
South DakotaResearch Site, Rapid City (Not yet recruiting)
TennesseeResearch Site, Franklin (Not yet recruiting)
Research Site, Knoxville (Not yet recruiting)
TexasResearch Site, Dallas
Research Site, Houston (Not yet recruiting)
Research Site, Humble (Not yet recruiting)
Research Site, Irving
UtahResearch Site, Sandy City (Not yet recruiting)
VirginiaResearch Site, Midlothian (Not yet recruiting)
West VirginiaResearch Site, Morgantown (Not yet recruiting)

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.