臨床研究等提出・公開システム

A master protocol to investigate efficacy and safety of elecoglipron in participants with obesity or overweight with or without T2DM (Embold)

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

Tsugumi Hirotaka

Astrazeneka K.K

3-1, Ofuka-cho, Kita-ku, Osaka-shi, Osaka

RD-clinical-information-Japan@astrazeneca.com

Tsugumi Hirotaka

Astrazeneka K.K

3-1, Ofuka-cho, Kita-ku, Osaka-shi, Osaka

+81-6-4802-3600

RD-clinical-information-Japan@astrazeneca.com

Recruiting

July. 06, 2026

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

- Legal age of consent and at least 18 years old

- Study 1
_BMI is greater than or equal to 30 kg/m2 or
_BMI is greater than or equal to 25 kg/m2 and less than 30 kg/m2 with at least one of the following weight-related comorbidities:
_Hypertension
_Prediabetes
_Dyslipidemia
_Cardiovascular disease
_Obstructive sleep apnea

Study 2 -BMI is greater than or equal to 25 kg/m2 and T2DM defined as below:
_Established diagnosis of T2DM
_Without established diagnosis of T2DM and HbAlc is greater than or equal to 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.

- Study l -Established diagnosis of T1DM or T2DM.

- Study 2 - Any of the following medical history, laboratory values, or complications related to diabetes:
_TlDM
_HbAlc is greater than or equal to 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

Both

Weight Management

Arm 1- Dose 1: Elecoglipron film- coated tablet once daily

Arm 2- Dose 2 : Elecoglipron film- coated tablet once daily

Arm 3 - Placebo: Placebo matching elecoglipron film- coated tablet once daily

Outcome Measure: Percent body weight loss
Description: Percent change from baseline to Week 72 in body weight

+81-29-353-2800

May. 19, 2026

Yes

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

Argentina/Australia/Brazil/Canada/Chile/China/France/Germany/India/Italy/Poland /Saudi Arabia/South Africa/South Korea/Spain/Taiwan/Turkey/United Kingdom/United States of America