EMBOLD

• Research type

  Research Study

• Full title

  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)

• IRAS ID

  1013694

• Contact name

  Emmanuel Amadi

• Contact email

  UKRegulatoryAffairs@astrazeneca.com

• Sponsor organisation

  AstraZeneca AB

• Eudract number

  2025-524688-19

• Research summary

  Background: People living with obesity or excess body weight face higher risks of serious health problems, including heart disease and type 2 diabetes (T2DM). Many people need support beyond diet and exercise. GLP 1 receptor agonists lower blood sugar, slow digestion, and reduce appetite. Most approved GLP 1 medicines are injections. Elecoglipron is an investigational, once daily tablet designed to work like GLP 1 and may be more convenient than injections.
  Purpose: This Phase 3 study will evaluate how well elecoglipron helps with weight loss and how safe it is in adults with obesity or excess weight, with or without T2DM. The main question is the percentage change in body weight from the start of treatment to week 72. Other questions include effects on blood sugar (HbA1c), blood pressure, waist size and quality of life.
  Design and population: About 4,500 adults (≥18 years) will be randomized in two parallel double blind, placebo controlled studies: one in adults without T2DM and one in adults with T2DM.
  • Randomized: a computer assigns participants to groups by chance.
  • Double blind: neither participants nor study staff know who receives elecoglipron or placebo.
  • Placebo controlled: some participants receive look alike tablets with no active medicine.
  Treatments and Procedures: The study will last approximately 2.5 years. In the main period, participants will receive either a gradual increase up to elecoglipron Dose 1 or Dose 2, or receive placebo. In the extension period, those on elecoglipron may continue the same dose or switch to placebo, and those on placebo will switch to an elecoglipron dose. Health is monitored with blood and urine tests, physical exams, ECGs, weight and waist measurements, blood pressure, medication reviews, and questionnaires.

• REC name

  London - Surrey Borders Research Ethics Committee

• REC reference

  26/LO/0204

• Date of REC Opinion

  17 Jun 2026

• REC opinion

  Further Information Favourable Opinion