NCT06352424已完成1 期
A Single-dose, Randomized, Placebo-controlled Phase I Study on the Effects of a Subcutaneous Dose of BI 1820237 and BI 456906, and Combination Thereof on Functional MRI Measurements in Otherwise Healthy Male and Female Individuals With Obesity/Overweight (Single-blind, Cross-over Design)
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Blood Oxygen Level Dependent (BOLD) signal changes following treatment with single dose of BI 1820237 alone, BI 456906 alone, and combination of BI 1820237 + BI 456906 versus placebo
研究概览
简要总结
The main objective of this trial is to investigate the effect of BI 1820237 alone, BI 456906 alone, combination of BI 1820237 and BI 456906 versus placebo on brain activity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 40 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects with obesity/overweight (otherwise healthy) according to the assessment of the Investigator, as based on a complete medical history including a physical examination, vital signs (Blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests
- •Age of 40 to 60 years (inclusive)
- •Body mass index (BMI) of 27.0 to 40.0 kg/m2 (inclusive). Overweight/obesity should be due to excess adipose tissue, as judged by the Investigator
- •Body weight greater than or equal to 75 kg
- •Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial
- •Male trial participants without need for contraception
- •Female trial participants, only if any of the following criteria for a highly effective contraception from at least 30 days before the first administration of trial medication until 2 months after last administration of trial medication are met:
- •Use of combined (estrogen and progestogen containing) hormonal contraception that prevents ovulation (intravaginal or transdermal)
- •Bilateral tubal occlusion
- •A vasectomised sexual partner who received medical assessment of the surgical success (documented absence of sperm according to verbal confirmation of female participant) and provided that partner is the sole sexual partner of the trial participant
- •Abstention from male-female sex. This is defined as being in line with the preferred and usual lifestyle of the patient. Periodic abstinence e.g. calendar, ovulation, symptothermal, post-ovulation methods; declaration of abstinence for the duration of exposure to study drug, and withdrawal are not acceptable.
- •Or female subject meets any of the following criteria:
- •Permanent sterilisation by hysterectomy, bilateral salpingectomy and/or bilateral oophorectomy
- •Woman is postmenopausal, defined as no menses for 1 year without an alternative medical cause (in questionable cases a blood sample with follicle stimulating hormone (FSH) above 40 U/L and estradiol below 30 ng/L is confirmatory)
排除标准
- •Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator
- •Measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 bpm and assessed as clinically relevant by the investigator
- •Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
- •Any evidence of a concomitant disease
- •Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- •Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair)
- •Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders
- •History of relevant orthostatic hypotension, fainting spells, or blackouts Further exclusion criteria apply.
研究组 & 干预措施
A-B-C-D
Experimental
- A: Treatment Test 1 (T1): BI 1820237 + Placebo for BI 456906
- B: Treatment Test 2 (T2): BI 456906 + Placebo for BI 1820237
- C: Treatment Test 3 (T3): BI 1820237 + BI 456906
- D: Treatment Reference (R1, R2): Placebo for BI 1820237 + Placebo for BI 456906
干预措施: BI 456906 (Drug)
A-B-C-D
Experimental
- A: Treatment Test 1 (T1): BI 1820237 + Placebo for BI 456906
- B: Treatment Test 2 (T2): BI 456906 + Placebo for BI 1820237
- C: Treatment Test 3 (T3): BI 1820237 + BI 456906
- D: Treatment Reference (R1, R2): Placebo for BI 1820237 + Placebo for BI 456906
干预措施: BI 1820237 (Drug)
A-B-C-D
Experimental
- A: Treatment Test 1 (T1): BI 1820237 + Placebo for BI 456906
- B: Treatment Test 2 (T2): BI 456906 + Placebo for BI 1820237
- C: Treatment Test 3 (T3): BI 1820237 + BI 456906
- D: Treatment Reference (R1, R2): Placebo for BI 1820237 + Placebo for BI 456906
干预措施: Placebo for BI 1820237 (Drug)
A-B-C-D
Experimental
- A: Treatment Test 1 (T1): BI 1820237 + Placebo for BI 456906
- B: Treatment Test 2 (T2): BI 456906 + Placebo for BI 1820237
- C: Treatment Test 3 (T3): BI 1820237 + BI 456906
- D: Treatment Reference (R1, R2): Placebo for BI 1820237 + Placebo for BI 456906
干预措施: Placebo for BI 456906 (Drug)
B-D-A-C
Experimental
干预措施: BI 456906 (Drug)
B-D-A-C
Experimental
干预措施: BI 1820237 (Drug)
B-D-A-C
Experimental
干预措施: Placebo for BI 1820237 (Drug)
B-D-A-C
Experimental
干预措施: Placebo for BI 456906 (Drug)
C-A-D-B
Experimental
干预措施: BI 456906 (Drug)
C-A-D-B
Experimental
干预措施: BI 1820237 (Drug)
C-A-D-B
Experimental
干预措施: Placebo for BI 1820237 (Drug)
C-A-D-B
Experimental
干预措施: Placebo for BI 456906 (Drug)
D-C-B-A
Experimental
干预措施: BI 456906 (Drug)
D-C-B-A
Experimental
干预措施: BI 1820237 (Drug)
D-C-B-A
Experimental
干预措施: Placebo for BI 1820237 (Drug)
D-C-B-A
Experimental
干预措施: Placebo for BI 456906 (Drug)
结局指标
主要结局
Blood Oxygen Level Dependent (BOLD) signal changes following treatment with single dose of BI 1820237 alone, BI 456906 alone, and combination of BI 1820237 + BI 456906 versus placebo
时间窗: 32 days plus up to 8 weeks wash-out for each sequence, up to 51 weeks
* in the fasted state in response to food visual stimuli and nutrient-specific food preference * assessed by task based functional magnetic resonance imaging (fMRI) in the whole brain
次要结局
未报告次要终点
研究者
研究点 (1)
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