NCT07797335招募中3 期
Efficacy and Safety of Zenagamtide s.c. Once Weekly Compared to Insulin Glargine s.c. Once Daily in Participants With Type 2 Diabetes and Increased Cardiovascular Risk Inadequately Controlled on 1-3 Oral Glucose-lowering Medications (AMBITION 7)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 1,778
- 试验地点
- 330
- 主要终点
- Non-inferiority of zenagamtide versus insulin glargine: change in haemoglobin A1c (HbA1c)
研究概览
简要总结
This study is being conducted to find out how well zenagamtide works and how safe it is compared to insulin glargine in participants with type 2 diabetes who are at higher risk of heart and blood vessel problems and are already taking 1 to 3 diabetes medications. There are 2 study treatments in this study taken as injections under the skin once a week. Participants will either get zenagamtide, (the treatment being tested) or insulin glargine (a comparator) and which treatment participants get is decided by chance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.
- •Male or female (sex assigned at birth, inclusive of all gender identities).
- •Age 45 years or above at the time of signing the informed consent.
- •Diagnosed with type 2 diabetes (T2D) greater than or equal to (≥) 180 days before screening.
- •Treatment with 1-3 marketed oral glucose-lowering medications (metformin, glinide, thiazolidinedione, sodium-glucose cotransporter-2 inhibitors (SGLT2i), α-glucosidase inhibitors (AGI), or sulfonylureas (SU) as a single agent or in combination) according to local label. Treatment with oral glucose-lowering medications must be stable (same drug(s), stable daily dose(s)) before screening.
- •Have HbA1c as determined by central laboratory at screening, if background glucose-lowering medications does not include a SU, or if background glucose-lowering medications includes a SU.
- •Increased risk of cardiovascular events as evidenced by at least one of the following (a-e):
- •Prior myocardial infarction (MI)
- •Documented coronary artery disease defined by at least one of the following:
- •≥ 50% stenosis of coronary artery on angiography or other imaging modality.
- •Ischaemia documented by stress test with any imaging modality.
- •Prior unstable angina with electrocardiogram (ECG) changes.
- •Prior coronary artery bypass graft or prior percutaneous coronary intervention.
- •Prior stroke (ischemic or haemorrhagic stroke).
- •History of chronic kidney disease based on medical records or as judged by the investigator as determined by central laboratory at screening.
- •Symptomatic peripheral arterial disease (PAD) defined as at least one of the following:
- •Intermittent claudication with an ankle-brachial index (ABI) < 0.85 at rest.
- •Intermittent claudication with a ≥ 50% stenosis in a lower extremity peripheral artery documented by X-ray angiography, magnetic resonance (MR) angiography, computer tomography (CT) angiography or Doppler ultrasound.
- •Prior revascularisation procedure of a lower extremity peripheral artery.
- •Lower extremity amputation at or above ankle due to atherosclerotic disease (excluding e.g., trauma or osteomyelitis)
排除标准
- •Myocardial infarction, stroke, transient ischaemic attack or hospitalisation for unstable angina pectoris within 60 days before screening.
- •Planned coronary, carotid or peripheral artery revascularisation.
- •Chronic or intermittent haemodialysis or peritoneal dialysis within 90 days before screening.
- •Diabetes- or weight related:
- •Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria before screening. However, insulin treatment for gestational diabetes is allowed as well as short term insulin treatment for a maximum of 14 consecutive days.
- •Treatment with glucagon-like-peptide-1 (GLP-1) receptor agonists (RA), dual GLP1/gastric inhibitory peptide (GIP) RAs (or any other GLP-1 based treatment), dipeptidyl peptidase 4 (DPP-4) inhibitors or amylin analogues before screening.
- •Participant with diabetic retinopathy or maculopathy who received treatment with retinal photocoagulation, vitrectomy or anti-Vascular Endothelial Growth Factor (anti-VEGF) within 180 days before screening or are expected to require treatment within 180 days after screening. Diabetic retinopathy or maculopathy must be verified by an eye examination performed before screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.
- •Known hypoglycaemic unawareness as indicated by the investigator according to Clarke's questionnaire question.
- •Any episodes of diabetic ketoacidosis before screening.
- •Uncontrolled thyroid disease as per investigator's discretion.
研究组 & 干预措施
Zenagamtide
Experimental
Participants will receive zenagamtide subcutaneously once weekly to one of the body parts: thigh, abdomen or upper arm.
干预措施: Zenagamtide (Drug)
Insulin glargine U-100
Active Comparator
Participants will receive Insulin glargine U-100 subcutaneously once daily to one of the body parts: thigh, abdomen or upper arm.
干预措施: Insulin glargine U-100 (Drug)
结局指标
主要结局
Non-inferiority of zenagamtide versus insulin glargine: change in haemoglobin A1c (HbA1c)
时间窗: From baseline (week 0) to week 52
Measured as percentage (%)-points
次要结局
- Change in systolic blood pressure(From baseline (week 0) to week 52)
- Change in high-sensitivity C-reactive protein (hsCRP)(From baseline (week 0) to week 52)
- Time to first occurrence of a 4-point major adverse cardiovascular events (MACE) endpoint consisting of: Cardiovascular (CV) death, non-fatal myocardial infarction, non-fatal stroke and hospitalisation for unstable angina(From baseline (week 0) to 104 weeks or more)
- Relative change in body weight(From baseline (week 0) to week 52)
- Superiority of zenagamtide versus insulin: Change in HbA1c(From baseline (week 0) to week 52)
- Time to first occurrence of a 3-point MACE endpoint consisting of: CV death, non-fatal myocardial infarction and non-fatal stroke(From baseline (week 0) to 104 weeks or more)
- Change in waist circumference(From baseline (week 0) to week 52)
- Change in Triglycerides(From baseline (week 0) to week 52)
- Change in Non-high-density lipoprotein (non-HDL) cholesterol(From baseline (week 0) to week 52)
研究者
研究点 (330)
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