2025-524688-19-00RecruitingPhase 3
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
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)
Source: EU CTIS (euclinicaltrials.eu) · Last updated 8 Sept 2026
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 1010 (estimated)
- First submitted
- 1 Apr 2026
- Start date
- 11 Aug 2026
- Lead sponsor
- AstraZeneca AB
- Diseases
- Obesity, Type 1 diabetes, Type 2 diabetes
- EU CT number
- 2025-524688-19-00
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 1010
- 64 sites in 4 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
AI-kivonat: who the study is looking for
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
Read by machine on 9 Nov 2026.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of acute (unless due to previously resolved gallstone pancreatitis and post-cholecystectomy) or chronic pancreatitis
Other illness
- History/family history (first degree biologic relatives) of medullary thyroid cancer or multiple endocrine neoplasia type 2
Lab values
- 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
Other
- Study 1 - Established diagnosis of T1DM or T2DM.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (64)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Herz Und Diabeteszentrum NRW Bad Oeynhausen Universitaetsklinik Der Ruhr-Universitaet Bochum | Bad Oeynhausen | Germany | Recruiting |
| Berufsgenossenschaftliches Universitaetsklinikum Bergmannsheil gGmbH | Bochum | Germany | Recruiting |
| Universitaetsklinikum Koeln AöR | Cologne | Germany | Recruiting |
| Technische Universitaet Dresden | Dresden | Germany | Recruiting |
| Diabetes Falkensee | Falkensee | Germany | Recruiting |
| SRH Wald-Klinikum Gera GmbH | Gera | Germany | Recruiting |
| Diabeteszentrum Hamburg West (DZHW) | Hamburg | Germany | Recruiting |
| Zentrum für klinische Forschung | Köln | Germany | Recruiting |
| Ambenet GmbH Das Ambulante Behandlungsnetz | Leipzig | Germany | Recruiting |
| Universitaetsklinikum Leipzig Aor | Leipzig | Germany | Recruiting |
| Universitaetsklinikum Schleswig-Holstein AöR | Luebeck | Germany | Recruiting |
| Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR | Mainz | Germany | Recruiting |
| CRS Clinical Research Services Management GmbH | Mannheim | Germany | Recruiting |
| Institut fuer Diabetesforschung Muenster GmbH | Muenster | Germany | Recruiting |
| Institute for Clinical Nutritional Medicine / TUM Campus at the Olympic Park | München | Germany | Recruiting |
| Mediccenter Nürnberg | Nürnberg | Germany | Recruiting |
| Rahman & Detho Studien GmbH | Obertshausen | Germany | Recruiting |
| R.E.D. Institut fuer medizinische Studien und Fortbildung GmbH | Oldenburg in Holstein | Germany | Recruiting |
| Vinzenz Von Paul Kliniken gGmbH | Stuttgart | Germany | Recruiting |
| Endokrinologikum Ulm | Ulm | Germany | Recruiting |
| Zentrum für Klinische Forschung Allgäu Oberschwaben | Wangen im Allgäu | Germany | Recruiting |
| Universitaetsklinikum Wuerzburg AöR | Wuerzburg | Germany | Recruiting |
| Instituto Medico Quirurgico San Rafael S.A. | A Coruna | Spain | Recruiting |
| Centro Periférico de Especialidades Bola Azul | Almería | Spain | Recruiting |
| Hospital Germans Trias i Pujol | Badalona | Spain | Recruiting |
| Hospital Universitari Vall d'Hebron | Barcelona | Spain | Recruiting |
| Hospital de la Santa Creu i Sant Pau | Barcelona | Spain | Recruiting |
| Hospital Clinic de Barcelona | Barcelona | Spain | Recruiting |
| Hospital Nisa Sevilla Aljarafe | Castilleja De La Cuesta | Spain | Recruiting |
| Hospital Universitario De Leon | León | Spain | Recruiting |
| Hospital Ruber Juan Bravo | Madrid | Spain | Recruiting |
| Hospital Universitario Marqués de Valdecilla | Santander | Spain | Recruiting |
| Hospital Provincial de Conxo | Santiago de Compostela | Spain | Recruiting |
| Nuevas Tecnologias En Diabetes Y En Endocrinologia S.L. Profesional | Sevilla | Spain | Recruiting |
| University Hospital Virgen Del Rocio S.L. | Sevilla | Spain | Recruiting |
| Hospital Universitari Joan XXIII de Tarragona | Tarragona | Spain | Recruiting |
| Hospital Clinico Universitario de Valencia | Valencia | Spain | Recruiting |
| Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico | Bologna | Italy | Recruiting |
| ARNAS Garibaldi Di Catania | Catania | Italy | Recruiting |
| CAST - Center for Advanced Studies and Technology di Chieti | Chieti | Italy | Recruiting |
| Azienda Ospedaliero-Universitaria Careggi | Florence | Italy | Recruiting |
| Ospedale Santa Maria Goretti Latina | Latina | Italy | Recruiting |
| ASST Fatebenefratelli Sacco | Milan | Italy | Recruiting |
| Azienda Ospedaliero Universitaria Pisana | Pisa | Italy | Recruiting |
| Azienda Unità Sanitaria Locale della Romagna | Ravenna | Italy | Recruiting |
| Fondazione Policlinico Universitario Campus Bio-medico In Forma A Bbreviata Fon | Rome | Italy | Recruiting |
| Azienda Ospedaliero-Universitaria Policlinico Umberto I | Rome | Italy | Recruiting |
| Policlinico San Donato S.p.A. | San Donato Milanese | Italy | Recruiting |
| Specderm Poznanska sp.j. | Bialystok | Poland | Recruiting |
| Niepublicznego Zakladu Opieki Zdrowotnej Specjalistyczny Osrodek Internistyczno Diabetologiczny | Bialystok | Poland | Recruiting |
| Pratia S.A. | Bydgoszcz | Poland | Recruiting |
| Unicardia Specjalistyczne Centrum Leczenia Chorob Serca I Naczyn & Unimedica Specjalistyczne Centrum Medyczne & Uniestetica Centrum Chirurgii Plastycznej Rekonstrukcyjnej I Medycyny Estetycznej Malopolskie Kliniki Specjalistyczne Sp. z o.o. | Cracow | Poland | Recruiting |
| Pratia S.A. | Cracow | Poland | Recruiting |
| Medyczne Centrum Diabetologiczno-Endokrynologiczno-Metaboliczne Diab-Endo-Met Sp. z o.o. | Cracow | Poland | Recruiting |
| Specjalistyczna Praktyka Lekarska Diabetologia, Leczenie Cukrzycy i Otylosci lek. Monika Piwowar | Kielce | Poland | Recruiting |
| Centrum Terapii Wspolczesnej J.M. Jasnorzewska S.K.A. | Lodz | Poland | Recruiting |
| Prywatna Praktyka Specjalistyczna, Gabinety Medyczne Matuszek, Beata Matyjaszek-Matuszek | Lublin | Poland | Recruiting |
| EKAMED sp. z o.o. | Lublin | Poland | Recruiting |
| Centrum Zdrowia Metabolicznego Pawel Bogdanski | Poznan | Poland | Recruiting |
| Uniwersyteckie Centrum Stomatologii i Medycyny Specjalistycznej Sp. z o.o. | Poznan | Poland | Recruiting |
| Prywatny Gabinet Lekarski Centrum Medyczne DIABETIKA Dorota Mlodawska-Choluj | Radom | Poland | Recruiting |
| Gyncentrum Sp. z o. o. | Warsaw | Poland | Recruiting |
| Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych i Administracji | Warsaw | Poland | Recruiting |
| Gabinet lekarski Maciej Karcz | Warszawa | Poland | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.