Obesity, Overweight
Conditions
Keywords
elecoglipron, AZD5004, ECC5004, GLP-1 receptor agonist, Weight loss, Weight management, Type 2 diabetes mellitus
Brief summary
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.
Detailed description
This is a Phase III, randomized, double-blind, placebo-controlled, multicenter study evaluating the efficacy and safety of oral elecoglipron in adults with obesity or overweight, with or without type 2 diabetes mellitus. Participants will be randomized to receive elecoglipron or placebo in accordance with the study protocol. Efficacy and safety will be assessed throughout the study.
Interventions
DRUGElecoglipron
Elecoglipron film coated tablet once daily
DRUGPlacebo
Placebo matching elecoglipron film-coated tablet once daily
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult participant aged 18 years or older at the time of informed consent. * Body mass index (BMI) at screening of: * 28 kg/m\^2 or higher, or * 24 kg/m\^2 to less than 28 kg/m\^2 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) * History of at least 1 self-reported unsuccessful dietary effort to lose body weight. * Participants with type 2 diabetes mellitus, if enrolled, and have HbA1c from 6.5% to less than 10.0% at screening.
Exclusion criteria
* 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. * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent change from baseline to Week 52 in body weight | Week 52 | Percent change from baseline to Week 52 in body weight. |
| Participants achieving at least 5% body weight loss at Week 52 | Week 52 | Achieved at least 5% body weight loss from baseline at Week 52. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Participants achieving at least 10% body weight loss at Week 52 | Week 52 | Achieved at least 10% body weight loss from baseline at Week 52. |
| Change in waist circumference from baseline to Week 52 | Week 52 | Absolute change from baseline to Week 52 in waist circumference(cm). |
Countries
China, Hong Kong, Malaysia, Philippines, Thailand
Contacts
CONTACTAstraZeneca Clinical Study Information Center
Outcome results
None listed