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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

Next steps

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
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

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (64)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Herz Und Diabeteszentrum NRW Bad Oeynhausen Universitaetsklinik Der Ruhr-Universitaet BochumBad OeynhausenGermanyRecruiting
Berufsgenossenschaftliches Universitaetsklinikum Bergmannsheil gGmbHBochumGermanyRecruiting
Universitaetsklinikum Koeln AöRCologneGermanyRecruiting
Technische Universitaet DresdenDresdenGermanyRecruiting
Diabetes FalkenseeFalkenseeGermanyRecruiting
SRH Wald-Klinikum Gera GmbHGeraGermanyRecruiting
Diabeteszentrum Hamburg West (DZHW)HamburgGermanyRecruiting
Zentrum für klinische ForschungKölnGermanyRecruiting
Ambenet GmbH Das Ambulante BehandlungsnetzLeipzigGermanyRecruiting
Universitaetsklinikum Leipzig AorLeipzigGermanyRecruiting
Universitaetsklinikum Schleswig-Holstein AöRLuebeckGermanyRecruiting
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöRMainzGermanyRecruiting
CRS Clinical Research Services Management GmbHMannheimGermanyRecruiting
Institut fuer Diabetesforschung Muenster GmbHMuensterGermanyRecruiting
Institute for Clinical Nutritional Medicine / TUM Campus at the Olympic ParkMünchenGermanyRecruiting
Mediccenter NürnbergNürnbergGermanyRecruiting
Rahman & Detho Studien GmbHObertshausenGermanyRecruiting
R.E.D. Institut fuer medizinische Studien und Fortbildung GmbHOldenburg in HolsteinGermanyRecruiting
Vinzenz Von Paul Kliniken gGmbHStuttgartGermanyRecruiting
Endokrinologikum UlmUlmGermanyRecruiting
Zentrum für Klinische Forschung Allgäu OberschwabenWangen im AllgäuGermanyRecruiting
Universitaetsklinikum Wuerzburg AöRWuerzburgGermanyRecruiting
Instituto Medico Quirurgico San Rafael S.A.A CorunaSpainRecruiting
Centro Periférico de Especialidades Bola AzulAlmeríaSpainRecruiting
Hospital Germans Trias i PujolBadalonaSpainRecruiting
Hospital Universitari Vall d'HebronBarcelonaSpainRecruiting
Hospital de la Santa Creu i Sant PauBarcelonaSpainRecruiting
Hospital Clinic de BarcelonaBarcelonaSpainRecruiting
Hospital Nisa Sevilla AljarafeCastilleja De La CuestaSpainRecruiting
Hospital Universitario De LeonLeónSpainRecruiting
Hospital Ruber Juan BravoMadridSpainRecruiting
Hospital Universitario Marqués de ValdecillaSantanderSpainRecruiting
Hospital Provincial de ConxoSantiago de CompostelaSpainRecruiting
Nuevas Tecnologias En Diabetes Y En Endocrinologia S.L. ProfesionalSevillaSpainRecruiting
University Hospital Virgen Del Rocio S.L.SevillaSpainRecruiting
Hospital Universitari Joan XXIII de TarragonaTarragonaSpainRecruiting
Hospital Clinico Universitario de ValenciaValenciaSpainRecruiting
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere ScientificoBolognaItalyRecruiting
ARNAS Garibaldi Di CataniaCataniaItalyRecruiting
CAST - Center for Advanced Studies and Technology di ChietiChietiItalyRecruiting
Azienda Ospedaliero-Universitaria CareggiFlorenceItalyRecruiting
Ospedale Santa Maria Goretti LatinaLatinaItalyRecruiting
ASST Fatebenefratelli SaccoMilanItalyRecruiting
Azienda Ospedaliero Universitaria PisanaPisaItalyRecruiting
Azienda Unità Sanitaria Locale della RomagnaRavennaItalyRecruiting
Fondazione Policlinico Universitario Campus Bio-medico In Forma A Bbreviata FonRomeItalyRecruiting
Azienda Ospedaliero-Universitaria Policlinico Umberto IRomeItalyRecruiting
Policlinico San Donato S.p.A.San Donato MilaneseItalyRecruiting
Specderm Poznanska sp.j.BialystokPolandRecruiting
Niepublicznego Zakladu Opieki Zdrowotnej Specjalistyczny Osrodek Internistyczno DiabetologicznyBialystokPolandRecruiting
Pratia S.A.BydgoszczPolandRecruiting
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.CracowPolandRecruiting
Pratia S.A.CracowPolandRecruiting
Medyczne Centrum Diabetologiczno-Endokrynologiczno-Metaboliczne Diab-Endo-Met Sp. z o.o.CracowPolandRecruiting
Specjalistyczna Praktyka Lekarska Diabetologia, Leczenie Cukrzycy i Otylosci lek. Monika PiwowarKielcePolandRecruiting
Centrum Terapii Wspolczesnej J.M. Jasnorzewska S.K.A.LodzPolandRecruiting
Prywatna Praktyka Specjalistyczna, Gabinety Medyczne Matuszek, Beata Matyjaszek-MatuszekLublinPolandRecruiting
EKAMED sp. z o.o.LublinPolandRecruiting
Centrum Zdrowia Metabolicznego Pawel BogdanskiPoznanPolandRecruiting
Uniwersyteckie Centrum Stomatologii i Medycyny Specjalistycznej Sp. z o.o.PoznanPolandRecruiting
Prywatny Gabinet Lekarski Centrum Medyczne DIABETIKA Dorota Mlodawska-CholujRadomPolandRecruiting
Gyncentrum Sp. z o. o.WarsawPolandRecruiting
Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych i AdministracjiWarsawPolandRecruiting
Gabinet lekarski Maciej KarczWarszawaPolandRecruiting

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This page is information, not medical advice. Discuss any trial with your doctor.