Efficacy and Safety of NNC0487-0111 s.c. Once-weekly Compared to Semaglutide s.c. Once-weekly in Participants With Overweight or Obesity, and Type 2 Diabetes (AMAZE 8)
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 1,000
- 试验地点
- 120
- 主要终点
- Relative change in body weight
研究概览
简要总结
The purpose of this clinical study is to find out if NNC0487-0111 is safe and effective for treating people who have excess body weight and type 2 diabetes. Participant will receive 2 injections every week: an active medicine and a placebo, both taken as injections under the skin once a week. The placebo is a treatment with no active medicine in it and will be given to all participants. In addition to placebo, participants will receive either of the active medicine NNC0487-0111 (the treatment being tested) or Semaglutide (an approved and commonly prescribed treatment used as comparator). 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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 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.
- •Diagnosed with type 2 diabetes mellitus ≥ 180 days before screening.
- •Haemoglobin A1c (HbA1c) 7-10 percentage (%) (53-86 millimole per mole [mmol/mol]) (both inclusive) as measured by the central laboratory at 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) before screening.
排除标准
- •Renal impairment with estimated Glomerular Filtration Rate (eGFR) < 30 milliliter (mL)/ minute (min)/1.73 meter squared (m^2) (2021 Chronic Kidney Disease Epidemiology Collaboration [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) 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 within 90 days before screening or in the period between screening and randomization. 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 before screening.
研究组 & 干预措施
NNC0487-0111
Participants will receive NNC0487-0111 and placebo matched to semaglutide subcutaneously once weekly as an adjunct to a reduced-calorie diet and increased physical activity.
干预措施: NNC0487-0111 (Drug)
NNC0487-0111
Participants will receive NNC0487-0111 and placebo matched to semaglutide subcutaneously once weekly as an adjunct to a reduced-calorie diet and increased physical activity.
干预措施: Placebo (matched to semaglutide) (Drug)
Semaglutide
Participants will receive semaglutide and placebo matched to NNC0487-0111 subcutaneously once weekly as an adjunct to a reduced-calorie diet and increased physical activity.
干预措施: Semaglutide (Drug)
Semaglutide
Participants will receive semaglutide and placebo matched to NNC0487-0111 subcutaneously once weekly as an adjunct to a reduced-calorie diet and increased physical activity.
干预措施: Placebo (matched to NNC0487-0111) (Drug)
结局指标
主要结局
Relative change in body weight
时间窗: From baseline (week 0) to week 84
Measured as percentage of body weight.
次要结局
- Change in waist circumference(From baseline (week 0) to week 84)
- Change in systolic blood pressure (SBP)(From baseline (week 0) to week 84)
- Change in body weight(From baseline (week 0) to week 84 and week 104)
- Change in body mass index (BMI)(From baseline (week 0) to week 84 and week 104)
- Number of participants with achievement of in haemoglobin A1c (HbA1c) < 7.0 percent (%) (yes/no)(From baseline (week 0) to week 84)
- Number of participants with achievement of HbA1c ≤ 6.5% (yes/no)(From baseline (week 0) to week 84)
- Number of participants with achievement of HbA1c < 5.7% (yes/no)(From baseline (week 0) to week 84)
- Change in fasting plasma glucose (FPG) measured as millimole per liter (mmol/L)(From baseline (week 0) to week 84)
- Change in FPG measured as milligrams per deciliter (mg/dL)(From baseline (week 0) to week 84)
- Ratio to baseline: change in fasting insulin(From baseline (week 0) to week 84)
- Ratio to baseline: change in urinary albumin-to-creatinine ratio (UACR)(From baseline (week 0) to week 84)
- Change in diastolic blood pressure (DBP)(From baseline (week 0) to week 84)
- Ratio to baseline: change in total cholesterol(From baseline (week 0) to week 84)
- Ratio to baseline: change in high-density lipoprotein (HDL) cholesterol(From baseline (week 0) to week 84)
- Ratio to baseline: change in low-density lipoprotein (LDL) cholesterol(From baseline (week 0) to week 84)
- Ratio to baseline: change in very low-density lipoprotein (VLDL) cholesterol(From baseline (week 0) to week 84)
- Ratio to baseline: change in non-HDL cholesterol(From baseline (week 0) to week 84)
- Ratio to baseline: change in triglycerides(From baseline (week 0) to week 84)
- Ratio to baseline: change in high-sensitivity C-reactive protein (hsCRP)(From baseline (week 0) to week 84)
- Number of Treatment Emergent Adverse Events (TEAEs)(From baseline (week 0) to week 84 and week 109)
- Number of Treatment Emergent Serious Adverse Events (TESAEs)(From baseline (week 0) to week 84 and week 109)
- Number of TEAEs leading to permanent treatment discontinuation(From baseline (week 0) to week 84 and week 109)
- Number of treatment-emergent clinically significant hypoglycaemic episodes (level 2) (< 3.0 millimole per liter [mmol/L] (54 milligrams per deciliter [mg/dL]), confirmed by a blood glucose (BG) meter)(From baseline (week 0) to week 84 and week 109)
- 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(From baseline (week 0) to week 84 and week 109)