Frontlight ResearchEarly access
Taking people in ItalyPhase 3
Testing elecoglipron for weight loss in adults with excess body weight
Tests elecoglipron against a dummy pill in adults with obesity or overweight.
Key facts
- Who runs it
- AstraZeneca AB
- Where
- Bologna, Catania, Chieti, Florence, Latina, Milan, Pisa, Ravenna, Rome, and San Donato Milanese, ItalySee the 11 sitesAlso in 3 other countries, 53 sites
- Trial code
- Registry title
- A trial to learn how safe elecoglipron is and how well it works in adults living with obesity or excess body weight with or without type 2 diabetes
- Status
- Recruiting
- Phase
- Phase 3
- People taking part
- 1,010 people, planned
- Started
- 11 Aug 2026
- Expected to end
- 30 Jul 2029
- Type of study
- Interventional
- Record updated
- 8 September 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with obesity or overweight. Some may have type 2 diabetes, others not. It tests elecoglipron against placebo for weight loss.
- Age
- 18 years or older
- Sex
- Women and men can join.
- Disease stage
- Study 1: BMI 30 kg/m2 or higher, or BMI from 27 to under 30 kg/m2 with at least one weight-related condition (high blood pressure, prediabetes, abnormal blood fats, heart and blood vessel disease, or sleep apnea). Study 2: BMI 27 kg/m2 or higher with type 2 diabetes.
- Earlier treatment
- At least one self-reported unsuccessful diet attempt to lose weight. Body weight stable for 90 days before screening (within 5% change).
- Biomarker or test result
- Study 2: type 2 diabetes diagnosis, or no diagnosis but HbA1c 6.5% (48 mmol/mol) or higher at screening.
Main reasons for not taking part
- Study 1: diagnosis of type 1 or type 2 diabetes
- Study 2: type 1 diabetes, or HbA1c 10% (86 mmol/mol) or higher
- Study 2: current or expected treatment for diabetic eye disease, or more than one severe low blood sugar episode in the past 180 days
- Past acute pancreatitis (unless from resolved gallstones and gallbladder removal) or chronic pancreatitis
- Medullary thyroid cancer or multiple endocrine neoplasia type 2 in the person or in close family
The registry criteria, word for word
Show all 9 criteriaShow less
Who can take part
- Legal age of consent and at least 18 years old
- Study 1 - ○ BMI ≥ 30 kg/m2 or ○ 27 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 ≥ 27 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
Who cannot take part
- 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
- 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
- Study 1 - Established diagnosis of T1DM or T2DM
Where in Italy
Also in 3 other countries, 53 sites
- Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere ScientificoBologna, ItalyTaking people
- ARNAS Garibaldi Di CataniaCatania, ItalyTaking people
- CAST - Center for Advanced Studies and Technology di ChietiChieti, ItalyTaking people
- Azienda Ospedaliero-Universitaria CareggiFlorence, ItalyTaking people
- Ospedale Santa Maria Goretti LatinaLatina, ItalyTaking people
- ASST Fatebenefratelli SaccoMilan, ItalyTaking people
- Azienda Ospedaliero Universitaria PisanaPisa, ItalyTaking people
- Azienda Unità Sanitaria Locale della RomagnaRavenna, ItalyTaking people
- Azienda Ospedaliero-Universitaria Policlinico Umberto IRome, ItalyTaking people
- Fondazione Policlinico Universitario Campus Bio-medico In Forma A Bbreviata FonRome, ItalyTaking people
- Policlinico San Donato S.p.A.San Donato Milanese, ItalyTaking people
About the trial
What the trial wants to find out
To determine whether elecoglipron is superior to placebo for percent body weight loss in two independent studies, in adults with obesity or overweight with or without T2DM
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record
Print a page for my doctorData and sources
- Registry record
- Listed on the EU's official list of trials (CTIS).
- Official 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)
- Plain-language title
- Testing elecoglipron for weight loss in adults with excess body weightGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 9 November 2026.
- Record updated
- 8 September 2026