NCT07822061招募中3 期
Efficacy and Safety of NNC0487-0111 s.c. Once-weekly in Japanese Participants With Overweight or Obesity (AMAZE 10)
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
- 400
- 试验地点
- 26
- 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 with excess body weight and to compare its effects with placebo. Participants will receive either NNC0487-0111, the treatment being tested, or placebo, a treatment with no active medicine. Which treatment participants receive is decided by chance. NNC0487-0111 is a new medicine that doctors cannot yet prescribe, but it has been tested in humans before.
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)
盲法说明
Sponsor staff involved in the clinical trial is masked according to company standard procedures.
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 the informed consent.
- •For participants with T2D at screening (max 25%), the following inclusion criteria apply
- •Diagnosed with T2D ≥ 180 days before screening.
- •Haemoglobin A1c (HbA1c) 7.0 -10.0% (53-86 millimole per mole (mmol/mol) (both inclusive) as measured by the central laboratory at screening.
- •Treatment with lifestyle intervention, and/or with 0-3 marketed oral antidiabetic drugs (OADs) (Metformin, glinide, thiazolidinedione, sodium-glucose cotransporter-2 inhibitors, α-glucosidase inhibitors, imeglimin, or sulfonylureas (SU) as a single agent or in combination) according to local label. Treatment with OADs should be stable (same drug(s), dose and dosing frequency) before screening.
- •For participants with knee OA at screening (approximately 50 participants), the following inclusion criteria apply
- •Clinical diagnosis of knee OA (American College of Rheumatology criteria) with radio-graphic changes (Kellgren-Lawrence grades 2 to 3 as per central reading) in the target knee. Target knee joint is defined as most symptomatic knee at screening. If pain in knees is equal, the target knee joint will be the dominant leg.
- •Symptomatic knee OA with first appearance of pain in the target knee > 90 days prior to screening and pain in the target knee for > 15 days over the prior 30 days.
- •Willingness to complete a 72-hour washout period of analgesics before all visits in-volving WOMAC Osteoarthritis Index NRS 3.1 (24-hour) (WOMAC) questionnaire (acetaminophen 4 gram/day is allowed as rescue medication up until 24 hours before those visits).
排除标准
- •- 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.
- •For participants without T2D at screening (including participants with and without knee OA), the following exclusion criteria apply in addition to criterion 1 (above):
- •HbA1c ≥ 6.5% (48 mmol/mol) as measured by the central laboratory at screening.
- •History of type 1 or type 2 diabetes mellitus.
- •For participants with T2D at screening, the following exclusion criteria apply in addition to criterion 1 (above):
- •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.
- •Renal impairment with estimated Glomerular Filtration Rate (eGFR) < 30 millilitre per minute per 1.73 m^2, (2021 Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula (by creatinine)), 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 per-formed 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.
- •For participants with knee OA, the following exclusion criteria apply in addition to cri-teria 1-3 (above):
- •Any joint prosthesis or joint replacement in the target knee.
- •Arthroscopy or injections into the target knee within the last 90 days prior to screening.
- •Any other joint disease in the target knee including gout and pseudogout.
研究组 & 干预措施
NNC0487-0111 Placebo
Placebo Comparator
Participants will receive placebo administered 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)
NNC0487-0111
Experimental
Participants will receive NNC0487-0111 administered subcutaneously once weekly with one of four dose levels as an adjunct to a reduced-calorie diet and increased physical activity.
干预措施: 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 measured according to Japan society for the Study of Obesity (JASSO) guideline(From baseline (week 0) to week 84)
研究者
研究点 (26)
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