Nutritional, Metabolic, Endocrine
Conditions
Interventions
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Participants are eligible to be included in the study only if all of the following criteria apply: Age 1 Participant must be = 18 years of age at the time of signing the informed consent. Type of Participant and Disease Characteristics 2 Participants with a diagnosis of T2DM as per World Health Organization or local diagnostic standards for at least 90 days prior to the Screening Visit (Visit 1). 3 T2DM inadequately managed with lifestyle management alone (ie, treatment-naïve or on no current glucose lowering agents) or a stable dose of metformin as judged by the Investigator for at least 90 days before the Screening Visit (Visit 1) and through the screening period. 4 HbA1c value of = 7% to = 10.5% (53 to 91.3 mmol/mol) as determined by the central laboratory at the Screening Visit (Visit 1). Weight 5 BMI of = 23 kg/m2 at the Screening Visit (Visit 1). 6 Stable body weight (self-reported or documented) for 90 days prior to the Screening Visit (Visit 1) (± 5% body weight change) and through the screening period as determined by the Investigator. Sex and Contraceptive/Barrier Requirements 7 Male and/or female assigned at birth, inclusive of all gender identities. Definitions for WOCBP and females of nonchildbearing potential and contraception recommendations for females and males are included in Appendix F, with further details on restricted contraception in Section 6.9.2.1. Informed Consent 8 Capable of giving signed informed consent as described in Appendix A, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol. 9 Provision of signed and dated written ICF before any mandatory study-specific procedures, sampling, or analysis.
Exclusion criteria
Exclusion criteria: Participants are excluded from the study if any of the following criteria apply: Diabetes 1 Any of the following medical history or complications related to: (a) T1DM, secondary forms of diabetes (including congenital forms), or history of ketoacidosis or hyperosmolar coma within 180 days prior to the Screening Visit (Visit 1) or during the screening period. (b) Currently receiving or anticipated to receive, therapeutic intervention for diabetic retinopathy and/or macular edema. Fundus photography or dilated fundoscopic exam will be performed as per the SoA (Section 1.3) by an ophthalmologist/optometrist or according to local practice to confirm eligibility. (c) Have had more than one episode of severe hypoglycemia, as defined by the occurrence of neuroglycopenic symptoms requiring the assistance of another person for recovery, within 180 days prior to the Screening Visit (Visit 1) or during the screening period, or has a history of hypoglycemia unawareness or poor recognition of hypoglycemic symptoms as per Investigator judgment. Weight 2 Any of the following that are related to medical reasons or planned/previous changes in weight (see further details in Section 5.3.5 and Appendix G): (a) Received any prescription or non-prescription medication or herbal supplements for weight loss within the last 90 days prior to the Screening Visit (Visit 1) and through the screening period. (b) Previous or planned (within study period) endoscopic or surgical weight loss procedures (eg, bariatric surgery or fitting of a weight loss device [eg, gastric balloon or duodenal barrier]). Exception: participants with fitted weight loss devices removed for more than 180 days prior to the Screening Visit (Visit 1) and stable body weight (as noted in Inclusion Criterion 6). (c) Planned to start a targeted weight loss program during the study other than lifestyle management considerations outlined in the protocol. Gastrointestinal/Liver 3 Have a known clinically significant condition affe
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the efficacy of elecoglipron 45 mg, elecoglipron 65 mg, and elecoglipron 65 mg + dapagliflozin 10 mg compared with placebo for glycemic control | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the efficacy of elecoglipron 45 mg, elecoglipron 65 mg, and elecoglipron 65 mg + dapagliflozin 10 mg compared with placebo for Diastolic Blood Pressure reduction ;To evaluate the efficacy of elecoglipron 45 mg, elecoglipron 65 mg, and elecoglipron 65 mg + dapagliflozin 10 mg compared with placebo for rescue medication ;To evaluate the efficacy of elecoglipron 45 mg, elecoglipron 65 mg, and elecoglipron 45 mg + dapagliflozin 10 mg compared with placebo for glycemic control ;To evaluate the efficacy of elecoglipron 45 mg, elecoglipron 65 mg, and elecoglipron 45 mg + dapagliflozin 10 mg compared with placebo for body weight reduction ;To evaluate the efficacy of elecoglipron 45 mg, elecoglipron 65 mg, and elecoglipron 45 mg + dapagliflozin 10 mg compared with placebo for Systolic Blood Pressure reduction ;To evaluate the efficacy of elecoglipron 45 mg, elecoglipron 65 mg, and elecoglipron 65 mg + dapagliflozin 10 mg compared with placebo for body weight reduction;To evaluate the efficacy of elecoglipron 45 mg, elecoglipron 65 mg, and elecoglipron 65 mg + dapagliflozin 10 mg compared with placebo for lipid parameter improvement | — |
Countries
South Africa
Contacts
Public ContactFatima Cassim
Country Head
Outcome results
None listed