A Study to Investigate the Efficacy and Safety of Elecoglipron in Asian Participants With Obesity or Overweight With or Without Type 2 Diabetes Mellitus

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorAstraZeneca

About this trial

The purpose of this study is to evaluate the efficacy and safety of elecoglipron compared with placebo adjunct to diet and exercise for weight management, in adult participants living with obesity or overweight with or without T2DM.

Eligibility criteria

Qualifiers

Adult participant aged 18 years or older at the time of informed consent.

28 kg/m² or higher, or

24 kg/m² to less than 28 kg/m² with at least 1 weight-related comorbidity.

Stable body weight (self-reported or documented) for 90 days prior to the screening visit (± 5% body weight change)

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Elecoglipron
  • Placebo

Treatment groups

351 Participants
are divided into 3 treatment groups

Sponsors and collaborators