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
Key facts
- Where
- Bad Oeynhausen, Bochum, Cologne, Dresden, Falkensee, Gera, Hamburg, Köln, Leipzig, Luebeck, Mainz, Mannheim, Muenster, München, Nürnberg, Obertshausen, Oldenburg in Holstein, Stuttgart, Ulm, Wangen im Allgäu és Wuerzburg, NémetországSee the 22 sites
- Phase
- 3. fázis
Where in Németország
- Herz Und Diabeteszentrum NRW Bad Oeynhausen Universitaetsklinik Der Ruhr-Universitaet BochumBad Oeynhausen, NémetországTaking people
- Berufsgenossenschaftliches Universitaetsklinikum Bergmannsheil gGmbHBochum, NémetországTaking people
- Universitaetsklinikum Koeln AöRCologne, NémetországTaking people
- Technische Universitaet DresdenDresden, NémetországTaking people
- Diabetes FalkenseeFalkensee, NémetországTaking people
- SRH Wald-Klinikum Gera GmbHGera, NémetországTaking people
- Diabeteszentrum Hamburg West (DZHW)Hamburg, NémetországTaking people
- Zentrum für klinische ForschungKöln, NémetországTaking people
- Ambenet GmbH Das Ambulante BehandlungsnetzLeipzig, NémetországTaking people
- Universitaetsklinikum Leipzig AorLeipzig, NémetországTaking people
- Universitaetsklinikum Schleswig-Holstein AöRLuebeck, NémetországTaking people
- Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöRMainz, NémetországTaking people
- CRS Clinical Research Services Management GmbHMannheim, NémetországTaking people
- Institut fuer Diabetesforschung Muenster GmbHMuenster, NémetországTaking people
- Institute for Clinical Nutritional Medicine / TUM Campus at the Olympic ParkMünchen, NémetországTaking people
- Mediccenter NürnbergNürnberg, NémetországTaking people
- Rahman & Detho Studien GmbHObertshausen, NémetországTaking people
- R.E.D. Institut fuer medizinische Studien und Fortbildung GmbHOldenburg in Holstein, NémetországTaking people
- Vinzenz Von Paul Kliniken gGmbHStuttgart, NémetországTaking people
- Endokrinologikum UlmUlm, NémetországTaking people
- Zentrum für Klinische Forschung Allgäu OberschwabenWangen im Allgäu, NémetországTaking people
- Universitaetsklinikum Wuerzburg AöRWuerzburg, NémetországTaking people
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?
Trial details
- Who runs it
- AstraZeneca AB
- Trial code
- EU 2025-524688-19-00
- Record updated
- 2026. szeptember 8.
- Original description
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 T2DMRead full original descriptionShow less
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)
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
Inclusion: 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.
Exclusion: 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.