NCT06970405撤回1 期
Randomized, Double-Blind, Placebo-Controlled Study of Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Effects of Garetosmab in Men and Post-Menopausal Women With Obesity Who Are Otherwise Healthy
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 入组人数
- 48
- 主要终点
- Incidence of treatment-emergent adverse events (TEAEs)
研究概览
简要总结
This study is researching an experimental drug called garetosmab, referred to as "study drug". The study is focused on otherwise healthy participants with obesity.
The aim of the study is to see how safe and tolerable the study drug is.
The study is looking at several other research questions, including:
- How much study drug is in the blood at different times
- What effect the study drug has on the blood clotting
- What effect the study drug has on hormone levels
- What effect the study drug has on some organs that produce hormones
- What effect hormones have on the side effects produced by the study drug
- Whether the body makes antibodies against the study drug (which could change how well the drug works or could lead to side effects)
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants with obesity (defined as Body Mass Index (BMI) ≥30 kg/m2) who are otherwise healthy, as defined in the protocol
- •Women must be postmenopausal, as defined in the protocol
- •Serum testosterone within age-adjusted normal range for men at screening
- •The platelet count is within the normal lower and upper laboratory range
排除标准
- •Patients diagnosed with Type 1 or Type 2 diabetes, as defined in the protocol
- •History of any severe, non-traumatic bleeding, and or a known pre-existing medical history of a bleeding, as defined in the protocol
- •History of clinically significant cardiovascular (eg, uncontrolled blood pressure), endocrine, respiratory, hepatic, renal, gastrointestinal, hematological, psychiatric, or neurological disease, as defined in the protocol
- •Any malignancy in the last 5 years prior to screening visit, except for non-melanoma skin cancer that have been resected with no evidence of metastatic disease
- •Any chronic active infection or has received anti-Hepatitis C Virus (HCV) treatments within the previous 6 months, as defined in the protocol
- •Antiplatelet therapy (eg clopidogrel, aspirin), anticoagulants (eg, warfarin, heparin, factor Xa inhibitor, or thrombin inhibitors) in the last 90 days or within 5 half-lives of the therapy at screening, whichever is longer
- •Use in the previous 90 days for >7 consecutive days at screening of anti-obesity medications, anabolic agents, systemic steroids, androgens, estrogens, or progestogens. Chronic stable doses of thyroid hormones in participants with normal thyroid function are allowed
- •For women, current use, or past use in the last 90 days at screening of hormonal replacement or contraceptive therapy
- •NOTE: Other Protocol-defined Inclusion/Exclusion Criteria Apply
研究组 & 干预措施
High Dose
Experimental
Randomized per the protocol
干预措施: Garetosmab (Drug)
Low Dose
Experimental
Randomized per the protocol
干预措施: Garetosmab (Drug)
Placebo
Placebo Comparator
Randomized per the protocol
干预措施: Matching Placebo (Drug)
结局指标
主要结局
Incidence of treatment-emergent adverse events (TEAEs)
时间窗: Through Week 32
Severity of TEAEs
时间窗: Through Week 32
次要结局
- Change in serum Follicle Stimulating Hormone (FSH) level in response to gonadotropin-releasing hormone (GnRH) injection(Pre-GnRH Baseline, Through Week 20 Post-GnRH)
- Percent change in serum FSH level in response to GnRH injection(Pre-GnRH Baseline, Through Week 20 Post-GnRH)
- Change in serum Luteinizing Hormone (LH) level in response to GnRH injection(Pre-GnRH Baseline, Through Week 20 Post-GnRH)
- Percent change in serum LH level in response to GnRH injection(Pre-GnRH Baseline, Through Week 20 Post-GnRH)
- Change in serum total testosterone level in response to GnRH injection(Pre-GnRH Baseline, Through Week 20 Post-GnRH)
- Percent change in serum total testosterone level in response to GnRH injection(Pre-GnRH Baseline, Through Week 20 Post-GnRH)
- Change in serum free testosterone level in response to GnRH injection(Pre-GnRH Baseline, Through Week 20 Post-GnRH)
- Percent change in serum free testosterone level in response to GnRH injection(Pre-GnRH Baseline, Through Week 20 Post-GnRH)
- Change in serum estradiol level in response to GnRH injection(Pre-GnRH Baseline, Through Week 20 Post-GnRH)
- Percent change in serum estradiol level in response to GnRH injection(Pre-GnRH Baseline, Through Week 20 Post-GnRH)
- Change in serum 17-hydroxyprogesterone (17-OHP) level in response to GnRH injection(Pre-GnRH Baseline, Through Week 20 Post-GnRH)
- Percent change in serum 17-OHP level in response to GnRH injection(Pre-GnRH Baseline, Through Week 20 Post-GnRH)
- Change in serum Dehydroepiandrosterone Sulphate (DHEA-S) level in response to GnRH injection(Pre-GnRH Baseline, Through Week 20 Post-GnRH)
- Percent change in serum DHEA-S level in response to GnRH injection(Pre-GnRH Baseline, Through Week 20 Post-GnRH)
- Change in serum androstenedione level in response to GnRH injection(Pre-GnRH Baseline, Through Week 20 Post-GnRH)
- Percent change in serum androstenedione level in response to GnRH injection(Pre-GnRH Baseline, Through Week 20 Post-GnRH)
- Change in cortisol level in response to Adrenocorticotropic Hormone (ACTH) level injection(Pre-ACTH Baseline, Through Week 20 post-ACTH)
- Percent change in cortisol level in response to ACTH injection(Pre-ACTH Baseline, Through Week 20 post-ACTH)
- Concentrations of garetosmab in serum(Through Week 32)
- Concentrations of total activin A in serum(Through Week 32)
- Change in bleeding time(Baseline, At Week 8)
- Percent change in bleeding time(Baseline, At Week 8)
- Change in thrombin time(Baseline, At Week 8)
- Percent change in thrombin time(Baseline, At Week 8)
- Change in Activated Partial Thromboplastin Time (aPTT)(Baseline, At Week 8)
- Percent change in aPTT(Baseline, At Week 8)
- Change in Prothrombin Time (PT)(Baseline, At Week 8)
- Percent change in PT(Baseline, At Week 8)
- Change in International Normalized Ratio (INR)(Baseline, At Week 8)
- Percent change in INR(Baseline, At Week 8)
- Change in platelets count(Baseline, At Week 8)
- Percent change in platelets count(Baseline, At Week 8)
- Change in serum ACTH level(Baseline, Through Week 20)
- Percent change in serum ACTH level(Baseline, Through Week 20)
- Change in serum FSH level(Baseline, Through Week 20)
- Percent change in serum FSH level(Baseline, Through Week 20)
- Change in serum LH level(Baseline, Through Week 20)
- Percent change in serum LH level(Baseline, Through Week 20)
- Change in serum Thyroid Stimulating Hormone (TSH) level(Baseline, Through Week 20)
- Percent change in serum TSH level(Baseline, Through Week 20)
- Change in serum Thyroxine (T4) level(Baseline, Through Week 20)
- Percent change in serum T4 level(Baseline, Through Week 20)
- Change in serum total testosterone level(Baseline, Through Week 20)
- Percent change in serum total testosterone level(Baseline, Through Week 20)
- Change in serum free testosterone level(Baseline, Through Week 20)
- Percent change in serum free testosterone level(Baseline, Through Week 20)
- Change in serum 17-OHP level(Baseline, Through Week 20)
- Percent change in serum 17-OHP level(Baseline, Through Week 20)
- Change in serum estradiol level(Baseline, Through Week 20)
- Percent change in serum estradiol level(Baseline, Through Week 20)
- Change in serum DHEA-S level(Baseline, Through Week 20)
- Percent change in serum DHEA-S level(Baseline, Through Week 20)
- Change in serum androstenedione level(Baseline, Through Week 20)
- Percent change in serum androstenedione level(Baseline, Through Week 20)
- Change in serum Human Growth Hormone (HGH) level(Baseline, Through Week 20)
- Percent change in serum HGH level(Baseline, Through Week 20)
- Change in serum Insulin-like Growth Factor (IGF)-1 level(Baseline, Through Week 20)
- Percent change in serum IGF-1 level(Baseline, Through Week 20)
- Change in serum cortisol level(Baseline, Through Week 20)
- Percent change in serum cortisol level(Baseline, Through Week 20)
- Incidence of Anti-Drug Antibodies (ADA) to garetosmab(Through Week 32)
- Titer of ADA to garetosmab(Through Week 32)
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