A Randomized, Double-blind, Phase 2, Dose-finding Trial of Once Weekly Petrelintide Compared With Placebo in Participants With Obesity or Overweight With Weight Related Comorbidities
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 493
- 试验地点
- 52
- 主要终点
- Percent change from baseline in body weight to Week 28
研究概览
简要总结
The main purpose of this study is to compare dose levels of petrelintide versus placebo with regards to effect on body weight, safety, and tolerability.
详细描述
Obesity is a chronic disease with a rapidly increasing prevalence associated with significant comorbidities. Petrelintide is a long-acting amylin analog in development for weight management.
This is a randomized, double-blind, placebo-controlled, parallel-group, multinational, multicenter, dose-finding, Phase 2 clinical trial. The trial will compare 5 doses of once-weekly (OW) subcutaneously administered petrelintide with placebo.
This study consists of 3 periods:
- A screening period of 2-3 weeks
- A treatment period of 42 weeks
- A safety follow-up period of 9 weeks.
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
- Double (Participant, Investigator)
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 participants having body mass index (BMI) ≥30.0 kg/m2 or BMI ≥27.0 kg/m2 with the presence of at least one of the following comorbidities: hypertension or dyslipidemia (treated or untreated).
- •A female participant is eligible to participate if she is:
- •A woman of nonchildbearing potential. OR
- •A woman of childbearing potential (WOCBP) who is not pregnant, does not intend to be pregnant, not lactating and is willing to use highly effective contraceptive methods (as required by local regulation or practice) throughout the trial and for 10 weeks after the last injection of the investigational medicinal product (IMP).
- •Ability to comply with the protocol requirements including self-administration of IMP with vial and syringe.
排除标准
- •Glycated hemoglobin (HbA1c) ≥48 mmol/mol (6.5%), as measured at screening.
- •History of type 1 or type 2 diabetes mellitus.
- •Treatment with glucose lowering agent(s) within 90 days prior to screening.
- •A self-reported change in body weight >5% within 90 days prior to screening.
- •Treatment with any medication (prescribed or over-the-counter) or alternative remedies (herbal or nutritional supplements) intended to promote weight loss within 6 months prior to screening.
- •Previous or planned (during the trial period) obesity treatment with surgery or a body weight loss device. However, liposuction or surgical removal of fat depots more than 1 year prior to screening or device-based interventions (e.g. sleeve, banding or similar) that have been removed more than 6 months prior to screening, are allowed.
- •Uncontrolled thyroid disease defined as thyroid stimulating hormone >4.20 mIU/L or <0.27 mIU/L as measured by the central laboratory at screening.
- •Lifetime history of a suicidal attempt.
- •History of major depressive disorder or other severe psychiatric disorders (e.g. schizophrenia or bipolar disorder).
- •Estimated glomerular filtration rate value <60.0 mL/min/1.73m2, calculated by the Chronic Kidney Disease-Epidemiology (CKD-EPI) Creatinine Equation17, measured at screening.
- •Impaired liver function, defined as alanine aminotransferase and/or aspartate aminotransferase ≥2.0 times or bilirubin >1.5 times upper normal limit, measured at screening.
- •Presence or history of acute or chronic pancreatitis.
- •Known clinically significant gastric emptying abnormality (for example, severe gastroparesis or gastric outlet obstruction) or chronic treatment that affects gastrointestinal (GI) motility.
- •Presence or history of cardiovascular disease including stable and unstable angina pectoris, myocardial infarction, transient ischemic attack, stroke, cardiac decompensation.
- •Presence or history of clinically significant arrhythmias or clinically significant conduction disorders.
- •Known or suspected hypersensitivity to amylin analogs or related products.
- •History of malignant neoplasms (except for basal or squamous cell skin cancer) within 5 years prior to screening.
- •Known or suspected abuse of alcohol or recreational drugs.
- •Participant previously treated with petrelintide or any other amylin analog.
研究组 & 干预措施
Petrelintide Dose 1
Participants will self-inject petrelintide dose 1 subcutaneously once a week.
干预措施: Petrelintide (Drug)
Petrelintide Dose 2
Participants will self-inject petrelintide dose 2 subcutaneously once a week.
干预措施: Petrelintide (Drug)
Petrelintide Dose 3
Participants will self-inject petrelintide dose 3 subcutaneously once a week.
干预措施: Petrelintide (Drug)
Petrelintide Dose 4
Participants will self-inject petrelintide dose 4 subcutaneously once a week.
干预措施: Petrelintide (Drug)
Petrelintide Dose 5
Participants will self-inject petrelintide dose 5 subcutaneously once a week.
干预措施: Petrelintide (Drug)
Placebo
Participants will self-inject matching placebo to petrelintide subcutaneously once a week.
干预措施: Placebo (Drug)
结局指标
主要结局
Percent change from baseline in body weight to Week 28
时间窗: From Baseline (Day 1) to Week 28
To compare the dose-response of increasing doses of petrelintide versus placebo on body weight, when added as an adjunct to a reduced-calorie diet and increased physical activity after 28 weeks of exposure.
次要结局
- Percentage of Participants achieving ≥5% Body Weight Loss at Weeks 28 and 42(From Baseline (Day 1) to Weeks 28 and 42)
- Percentage of Participants achieving ≥10% Body Weight Loss at Weeks 28 and 42(From Baseline (Day 1) to Weeks 28 and 42)
- Change from baseline in body weight to Weeks 28 and 42(From Baseline (Day 1) to Weeks 28 and 42)
- Change from baseline in waist circumference to Weeks 28 and 42(From Baseline (Day 1) to Weeks 28 and 42)
- Percent change from baseline in body weight to Week 42(From Baseline (Day 1) to Week 42)
- Change from baseline in hemoglobin A1c (HbA1c) to Week 42(From Baseline (Day 1) to Week 42)
- Change from baseline in fasting glucose to Week 42(From Baseline (Day 1) to Week 42)
- Change from baseline in high-sensitivity C-reactive protein (hsCRP) to Week 42(From Baseline (Day 1) to Week 42)
- Change from baseline in fasting lipids to Week 42(From Baseline (Day 1) to Week 42)
- Number of treatment emergent adverse events (TEAEs)(From Baseline (Day 1) to Week 51)
- Occurrences of anti-drug antibodies (ADAs) to petrelintide(From Baseline (Day 1) to Week 51)