Weight Management
Conditions
Brief summary
This master study protocol, Study D7260C00015, covers 2 independent, pivotal studies, Study 1 and Study 2. Each study is a global, randomized, double-blind, parallel-group, multicenter, Phase III study to assess the efficacy and safety of elecoglipron compared with placebo adjunct to diet and exercise for weight management, in adults living with obesity or overweight with at least one weight-related comorbidity, and without T2DM (Study 1) or with T2DM (Study 2).
Detailed description
This is a Phase III, global, randomized, parallel-group, double-blind, placebo-controlled, multicenter study to assess the efficacy and safety of 2 doses of elecoglipron compared with placebo, given once daily as oral tablets. This protocol covers two independent pivotal studies in adults aged 18 years and above, who are living with obesity (BMI ≥ 30 kg/m2), or overweight (BMI ≥ 25 kg/m2) and have at least 1 weight-related comorbidity (Hypertension, Prediabetes, Dyslipidemia, CV disease and/or Obstructive sleep apnea) without T2DM (Study 1) and as well as those who are living with obesity or overweight with T2DM (Study 2). Approximately 3000 participants will be randomized in the study 1 and 1500 participants in the study 2. The primary endpoint is percent change in body weight from baseline at 72 weeks.
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
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Legal age of consent and at least 18 years old * Study 1 - * BMI ≥ 30 kg/m2 or * 25 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 ≥ 25 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 criteria
* Study 1 - Established diagnosis of T1DM or T2DM. * 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 * 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 body weight loss | 72 weeks | Percent change from baseline to Week 72 in body weight |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Absolute body weight loss | 72 weeks | Absolute change from baseline to Week 72 in body weight (kg) |
| Total body weight loss of at least 5%, 10%, and 15% | 72 weeks | * Achieved ≥ 5% body weight loss from baseline at Week 72 * Achieved ≥ 10% body weight loss from baseline at Week 72 * Achieved ≥ 15% body weight loss from baseline at Week 72 |
| Percent body weight loss in participants with body mass index (BMI) ≥ 27 kg/m2 at baseline | 72 weeks | Percent change from baseline to Week 72 in body weight |
| Waist circumference reduction | 72 weeks | Absolute change from baseline to Week 72 in waist circumference (cm) |
| Glycemic control | 72 weeks | Change from baseline to Week 72 in hemoglobin A1c (HbA1c) (%) |
| Achieving normoglycemia in participants with HbA1c ≥ 5.7% (39 mmol/mol) at baseline | 72 weeks | Achieved normoglycemia (HbA1c \< 5.7% \[39 mmol/mol\]) at Week 72 |
| Study 2 only: Achieving glycemic control in participants with HbA1c ≥ 7.0% (53 mmol/mol) at baseline | 72 weeks | * Achieved HbA1c \< 7.0% (53 mmol/mol) at Week 72 * Achieved HbA1c ≤ 6.5% (48 mmol/mol) at Week 72 |
| Systolic blood pressure reduction | 72 weeks | Change from baseline to Week 72 in systolic blood pressure (mmHg) |
Countries
Argentina, Australia, Brazil, Canada, Chile, China, Germany, India, Italy, Japan, Poland, Saudi Arabia, South Africa, South Korea, Spain, Taiwan, Turkey (Türkiye), United Kingdom, United States
Contacts
CONTACTAstraZeneca Clinical Study Information Center
PRINCIPAL_INVESTIGATORProf. Melanie Davies, MBChB
Diabetes Research Centre Leicester Diabetes Centre - Bloom University of Leicester
PRINCIPAL_INVESTIGATORDr. Ania Jastreboff, MD, PhD
Yale University
Outcome results
None listed