A Phase II, Randomized, Double Blind, Parallel Group,46 Weeks Dose-finding Study of BI 456906 Administered Once Weekly Subcutaneously Compared With Placebo in Patients With Obesity or Overweight
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 387
- 试验地点
- 43
- 主要终点
- Percentage Change in Body Weight From Baseline to Week 46
研究概览
简要总结
This study is open to adults, aged 18 to 75 years, with overweight or obesity. People with body mass index (BMI) of 27 or higher to join the study. People who have diabetes cannot participate. The purpose of this study is to find out whether a medicine called BI 456906 helps people lose weight.
Participants are put into 5 groups by chance. 4 groups get different doses of BI 456906. The fifth group gets placebo. Participants get BI 456906 or placebo as injections under the skin once a week. Placebo injections look like BI 456906 injections but do not contain any medicine.
Participants are in the study for about a year. During this time, there are about 20 in-person visits to the study site. At the study site visits, doctors measure participants' body weight. Results are compared between the BI 456906 groups and the placebo group. The doctors also regularly check the general health of the participants.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult ≥ 18 years and < 75 years of age at screening
- •Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial.
- •Obesity or Overweight defined as BMI ≥27 kg/m2 at screening
- •A minimum absolute body weight of 70 kg for females and 80 kg for males at screening
- •Male or female participants. Women of childbearing potential (WOCBP)1 must be willing and able to use two forms of effective contraception where at least one form is highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria is provided in the patient information.
- •Patients must have undergone at least one previous unsuccessful nonsurgical weight-loss attempt per investigator's judgement
- •Exclusion criteria:
- •Body weight change of over +/- 5% or more in the past 12 weeks prior to randomization. There must be documentation of weight in the past 12 weeks before randomization.
- •Obesity induced by an endocrinologic disorder (i.e. Cushing Syndrome, hypogonadism, growh hormone deficiency. However, well controlled hypothyroidism, polycystic ovarian disease are still allowed)
- •A HbA1c ≥ 6.5% at screening or diagnosed with type 1 or type 2 diabetes mellitus
- •Exposure to Glucagon like peptide-1 receptor agonist (GLP-1Ra) based therapies within three months prior to screening
- •Any suicidal behaviour in the past 2 years, any suicidal ideation of type 4 or 5 in the Columbia-Suicide Severity Rating Scale (CSSRS) within 3 months before screening, or during screening period
- •History of major depressive disorder within 2 years before randomization
- •Major depressive symptoms (defined as a screening Patient Health Questionnaire-9 [PHQ-9] score ≥15) at screening and/or during screening period
- •Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders at screening
- •Chronic or relevant acute infections (including but not limited to respiratory tract infections, urinary tract infection, bladder infection, enterocolitis, abscess, tuberculosis, meningitis, influenza, Epstein-Barr virus, HIV/AIDS, and hepatitis B or C, and severe acute respiratory syndrome coronavirus type 19 (SARS CoV-2) (as confirmed by Polychain reaction (PCR) test)), within 2 weeks from screening or during screening.
- •Further exclusion criteria apply
排除标准
- 未提供
研究组 & 干预措施
3.6 mg BI 456906
干预措施: BI 456906 (Drug)
4.8 mg BI 456906
干预措施: BI 456906 (Drug)
0.6 mg BI 456906
干预措施: BI 456906 (Drug)
Placebo group
干预措施: Placebo (Drug)
2.4 mg BI456906
干预措施: BI 456906 (Drug)
结局指标
主要结局
Percentage Change in Body Weight From Baseline to Week 46
时间窗: Baseline, Week 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 28, 32, 36, 40, and 46.
Percentage change in body weight from baseline to Week 46 was modeled using a mixed model for repeated measures (MMRM) with fixed effects for baseline body weight as a continuous linear covariate, and treatment, gender, visit, treatment by visit interaction and baseline by visit interaction as factors, using visit (Week 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 28, 32, 36, 40, and 46) as repeated measures, an unstructured covariance matrix to model within subject measurements, adjusted mean (standard error) at Week 46 is reported. For analysis, all available post-baseline body weight measurements (on- and off-treatment) were used, except those for participants who discontinued treatment early due to COVID-19. For these participants only on-treatment values were used. That is, a hypothetical strategy was used for intercurrent event (ICE) "COVID-19 pandemic-related early treatment discontinuation", a treatment policy strategy for ICE "non-pandemic-related early treatment discontinuation".
次要结局
- Absolute Change in Waist Circumference From Baseline to Week 46(Baseline, Week 6, 12, 18, 24, 32, 40, and 46.)
- Weight Loss of ≥ 5% of Baseline Weight at Week 46(At baseline and at Week 46.)
- Weight Loss of ≥ 10% of Baseline Weight at Week 46(At baseline and at Week 46.)
- Weight Loss of ≥ 15% of Baseline Weight at Week 46(At baseline and at Week 46.)
- Absolute Change in Systolic Blood Pressure From Baseline to Week 46(Baseline, Week 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 28, 32, 36, 40, and 46.)
- Absolute Change in Body Weight From Baseline to Week 46(Baseline, Week 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 28, 32, 36, 40, and 46.)
- Absolute Change in Diastolic Blood Pressure From Baseline to Week 46(Baseline, Week 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 28, 32, 36, 40, and 46.)