2024-520441-23-00招募中3 期
Efficacy and safety of NNC0487-0111 s.c. once-weekly in participants with overweight or obesity, and type 2 diabetes (AMAZE 2)
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
- 310
- 试验地点
- 35
- 主要终点
- Relative change in body weight
研究概览
简要总结
To confirm superiority of 00 mg, 00 mg, 00 mg, 00 mg NNC0487-0111, each versus placebo on change in body weight in participants with overweight or obesity, and type 2 diabetes (T2D)
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Male or female (sex at birth).
- •Age 18 years or above at the time of signing informed consent.
- •BMI CCI kg/m
- •Diagnosed with type 2 diabetes mellitus ≥ 180 days before screening.
- •Treatment with lifestyle intervention, and/or 0-3 marketed oral antidiabetic drugs (OAD)s (metformin, α-glucosidase inhibitors (AGI), glinides, sodium-glucose cotransporter 2 inhibitor (SGLT2i), thiazolidinediones, or sulfonylureas (SU) as a single agent or in combination) according to local label. Treatment with oral antidiabetic drugs should be stable (same drug(s), dose and dosing frequency) for at least CCI before screening.
- •Haemoglobin A1c (HbA1c) 7-10% (53-86 mmol/mol) (both inclusive) as measured by the central laboratory at screening.
排除标准
- •Renal impairment with estimated Glomerular Filtration Rate (eGFR) < 30 mL/min/1.73 m2 (2021 CKD-EPI formula), at screening.
- •Participant with diabetic retinopathy or maculopathy who received treatment with retinal photocoagulation, vitrectomy or anti-Vascular Endothelial Growth Factor (anti-VEGF) within180 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 within 90 days 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.
- •Recurrent severe hypoglycaemic episodes within the last year as judged by the investigator.
- •Treatment with glucagon-like peptide-1 (GLP-1) receptor agonists (RA), dual GLP-1/gastric inhibitory peptide (GIP) RAs (or any other GLP-1 based treatment), or amylin analogues within CCI before screening.
研究组 & 干预措施
Placebo
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Relative change in body weight
Relative change in body weight
次要结局
- CCI
- Change in waist circumference
- Change in haemoglobin A1c (HbA1c)
- Change in systolic blood pressure (SBP)
- Change in Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) physical function score
- Change in SF-36v2® Health Survey Acute (SF-36v2 Acute) physical functioning scorea
- Change in body weight
- Change in body mass index (BMI)
- Change in IWQOL-Lite-CT Physical Psychosocial Total score
- Achievement of HbA1c < 7.0% (Yes/No)
- Achievement of HbA1c ≤ 6.5% (Yes/No)
- Achievement of HbA1c < 5.7% (Yes/No)
- Change in fasting plasma glucose (FPG)
- Change in fasting insulin
- Change in urinary albumin-to-creatinine ratio (UACR)
- Change in diastolic blood pressure
- Change in lipids: Total cholesterol High-density lipoprotein (HDL) cholesterol Low-density lipoprotein (LDL) cholesterol Very low-density lipoprotein (VLDL) cholesterol Non-HDL cholesterol TriglycerideS
- Change in high-sensitivity C-reactive protein (hsCRP)
- Number of Treatment Emergent Adverse Events (TEAEs)
- Number of Treatment Emergent Serious Adverse Events (TESAEs)
- Number of Treatment Emergent Adverse Events (TEAEs) leading to permanent treatment discontinuation
- Number of treatment emergent clinically significant hypoglycaemic episodes (level 2) (< 3.0 mmol/L (54 mg/dL), confirmed by a blood glucose (BG) meter)
- Number of treatment emergent severe hypoglycaemic episodes (level 3): hypoglycaemia associated with severe cognitive impairment requiring external assistance for recovery, with no specific glucose threshold
研究者
EU Submission Hub
Scientific
Novo Nordisk A/S
研究点 (35)
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