NCT07008456招募中2 期
A Phase II Study to Investigate the Efficacy and Safety of Two Different Doses of Twice Daily Distal Jejunal-release Dextrose Beads Formulations (APHD 012 and APHD 002) Combined With a Gel Composition, Compared With Two Different Doses of the Placebo Beads Formulations (APHP 012 and APHP 002) Combined With a Gel Composition in Obese Subjects With Weight Related Comorbidities
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 102
- 试验地点
- 6
- 主要终点
- Body weight
研究概览
简要总结
The goal of this randomized, double-blind, placebo-controlled, phase IIa study is to demonstrate superiority on body weight reduction of two different doses of twice daily distal jejunal-release dextrose beads formulations (APHD 012 and APHD 002) combined with a gel composition, compared with two different doses of the placebo beads formulations (APHP 012 and APHD 002) combined with a gel composition in obese subjects with weight related comorbidities.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female subjects between an age of 18 (or the legal age of consent in the jurisdiction where the study is conducted) and 75 at the time of signing Informed Consent Form (ICF).
- •2. Body Mass Index (BMI) of
- •≥27 kg/m2 and <30 kg/m2 with at least 1 of the following weight-related comorbidities
- •hypertension: on blood-pressure (BP)-lowering medication or having systolic BP (SBP) ≥140 mmHg or diastolic BP (DBP) ≥90 mmHg at Screening
- •dyslipidaemia: on lipid-lowering medication or having low-density lipoprotein (LDL) ≥160 mg/dL (4.1 mmol/L) or triglycerides ≥150 mg/dL (1.7 mmol/L), or high-density lipoprotein (HDL) <40 mg/dL (1.0 mmol/L) for men or HDL <50 mg/dL (1.3 mmol/L) for women at Screening
- •cardiovascular disease (for example, ischemic cardiovascular disease, New York Heart Association [NYHA] Functional Classification Class I-II heart failure.)
- •obstructive sleep apnoea (only in participants >30 years of age)
- •Stable body weight for the 3 months prior to randomization (<5% body weight gain and/or loss)
- •History of at least one self-reported unsuccessful dietary effort to lose body weight
- •Fully vaccinated against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) during Coronavirus Disease 2019 (COVID-19) pandemic. Full Vaccination means having received all recommended doses of a COVID-19 vaccine listed by either of World Health Organization (WHO)-Emergency Use Listing (WHO-EUL), Food and Drug Administration (FDA) or European Medicines Agency (EMA) or a mix and match series composed of any heterologous combination of WHO-EUL/FDA/EMA-approved or authorized COVID-19 vaccines. Alternatively, a proven recovery from a COVID-19 infection in combination with at least one vaccination with a WHO, FDA, EMA listed vaccine qualifies as a full vaccination. The vaccination program must have been completed at least two weeks prior ICF signed. For the avoidance of doubt, the vaccination scheme received shall be in compliance with the current rules defined by the relevant health authorities in the US or Europe.
- •6. Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol
排除标准
- •1. Prior or planned surgical treatment for obesity (excluding liposuction or abdominoplasty, if performed >1 year prior to screening)
- •Obesity induced by other endocrinologic disorders (for example, Cushing's syndrome) or diagnosed monogenetic or syndromic forms of obesity (for example, Melanocortin 4 Receptor deficiency or Prader-Willi Syndrome)
- •Plan to have endoscopic and/or device-based therapy for obesity or have had device removal within the last 12 months prior to screening including but not limited to
- •mucosal ablation
- •gastric artery embolization
- •intragastric balloon
- •duodenal-jejunal endoluminal liner.
- •Renal impairment measured as estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m2 during screening.
- •5. Any of the following: myocardial infarction, stroke, hospitalization for unstable angina or transient ischaemic attack within the past 60 days prior to screening
- •Subject presently classified as being in New York Heart Association (NYHA) Class III and IV
- •Elevated resting pulse rate (>100 bpm) at Screening and Visit 1
- •Electrocardiogram (ECG) considered clinic ally significant by the Investigator at Screening
- •Known clinically significant gastric emptying abnormalities (for example, severe gastroparesis or gastric outlet obstruction), past gastric bypass (bariatric) surgery or restrictive bariatric surgery (for example, Lap-Band®), or chronic intake of drugs directly affecting gastrointestinal (GI) motility
- •History or presence of acute or chronic pancreatitis.
- •History or presence of acute or chronic diverticulitis or diverticulosis.
- •History or presence of a clinically significant active autoimmune abnormality (for example, lupus or rheumatoid arthritis)
- •History or presence of clinically significant gallbladder disease
- •Signs and symptoms of any other liver disease other than non-alcoholic fatty liver disease, or any of the following as determined during screening
- •Alanine aminotransferase (ALT) level >3.0X Upper limit of normal (ULN) for the reference range
- •Alkaline phosphatase (ALP) level >1.5X ULN for the reference range, or
- •Total Bilirubin >1.5X ULN for the reference range (except for cases of known Gilbert's Syndrome)
- •Evidence of hypothyroidism or hyperthyroidism based on clinical evaluation and/or an abnormal thyroid-stimulating hormone that, in the opinion of the Investigator, would pose a risk to patient safety. Subjects on a stable dose of thyroid replacement therapy for at least the prior 3 months before Visit 1 who are clinically euthyroid and who are anticipated to remain on this dose throughout the trial period may be eligible if they meet the other criteria
- •Known self or family history (first-degree relative) of multiple endocrine neoplasia type 2A or type 2B, thyroid C-cell hyperplasia, or medullary thyroid carcinoma
- •Eating habits consisting of eating relevant amounts of food throughout the night (after 10 p.m.; except if working on night shifts)
- •History or presence of bulimia or anorexia nervosa
- •History or presence of significant active or unstable Major Depressive Disorder (MDD) or other severe psychiatric disorder (for example, schizophrenia, bipolar disorder, or other serious mood or anxiety disorder) within the last 2 years.
- •20. Lifetime history of suicide attempt
- •History of malignant neoplasms within the past 5 years prior to screening. Basal and squamous cell skin cancer and any carcinoma in-situ are allowed
- •Evidence of human immunodeficiency virus (HIV) and/or positive HIV antibodies historically or at Screening
- •Evidence of hepatitis B and/or positive hepatitis B surface antigen.
- •Hepatitis C as defined by presence of positive hepatitis C antibodies.
- •Unstable treatment with glucose-lowering agent(s) within 90 days before Visit 1
- •Treatment with incretin mono- or dual receptor agonists (e.g., Glucagon-like peptide 1 (GLP-1) or GLP-1/ Glucose-dependent insulinotropic polypeptide (GIP)) within 180 days prior to screening and planned during the present study
- •Use of non-herbal Chinese medicine or other non-herbal local medicine with unknown/unspecified content within 90 days before screening
- •Surgery scheduled for the duration of the trial, except for minor surgical procedures, in the opinion of the investigator
- •Known or suspected abuse of alcohol or recreational drugs
- •Illicit drug abuse (marihuana, amphetamines, barbiturates, cocaine, opiates, phencyclidine and benzodiazepines)
- •Known or suspected hypersensitivity to trial product(s) or related products
- •Participation in another clinical trial within 90 days before screening
- •Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using a highly effective contraceptive method
- •Any disorder, unwillingness or inability, not covered by any of the other exclusion criteria, which in the investigator's opinion, might jeopardize the subject's safety or compliance with the protocol
研究组 & 干预措施
APHP-012
Placebo Comparator
12 g placebo beads
干预措施: APHP-012 (Drug)
APHP-002
Placebo Comparator
2 g placebo beads
干预措施: APHP-002 (Drug)
APHD-012
Active Comparator
12 g dextrose beads
干预措施: APHD-012 (Drug)
APHD-002
Active Comparator
2 g dextrose beads
干预措施: APHD-002 (Drug)
结局指标
主要结局
Body weight
时间窗: 24 weeks
Mean percent change in body weight from Baseline at Week 24
次要结局
- Blood Pressure(24 weeks)
- Fasting Glucose(24 weeks)
- HbA1c(24 weeks)
- Lipoproteins lipids(24 weeks)
研究者
研究点 (6)
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