EUCTR2020-005989-34-DE招募中1 期
A Phase II, randomized, double-blind, placebo-controlled, parallel-group proof-of-concept study to evaluate efficacy and safety of distal jejunal-release dextrose (Aphaia technology, AT) in obese subjects - 034B20
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 150
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Obese, male and female subjects 18 – 70 years of age.
- •2. Body mass index 30.0 - 39.9 kg/m2 .
- •3. Stable body weight: gain or loss in body weight < 5 kg over last 3 months prior Day 1.
- •4. Trial of lifestyle modification in the past (e.g. behavioral intervention, dieting, physical activity) which did not lead to achieving desired weight loss or sustaining weight loss.
- •5. Obese subjects with or without one or more of the following conditions:
- •a) NAFL – simple steatosis based on a FibroScan™ CAP test result at Screening (CAP score = 238 dB/m (steatosis grades 1 – 3) and FibroScan™ fibrosis score at Screening < 7.5 kPa (F0 – F1 fibrosis score).
- •b) NAFL with fibrosis – steatohepatitis based on FibroScan™ CAP test result at Screening (CAP score =238 dB/m (steatosis grades 1 – 3) and FibroScan™ fibrosis score at Screening = 7.5 kPa and < 14 kPa (F2 – F3 fibrosis score).
- •c) Confirmed medical history of metabolic syndrome.
- •d) HOMA IR score = 2.
- •e) Confirmed medical history of T2DM diagnosis or HbA1c = 7.0 and = 10 % (based on screening values).
- •f) High total cholesterol values (subjects on lipid-lowering medication for elevated total cholesterol or with total cholesterol = 240 mg/dL (based on screening values).
- •g) Hypertension (subjects on antihypertensive medication or with stage 1 hypertension (SBP 140-159 mmHg and/or DBP 90-99 mmHg (based on screening values)).
- •6. Fully vaccinated against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) during 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), 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 Informed Consent Form (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.
- •7. Female subjects are not pregnant or lactating, are surgically sterilized, postmenopausal (no menses for the previous 12 months). Female subjects of childbearing potential agree to undergo pregnancy tests and to use an appropriate method of contraception (i.e. oral contraceptive steroids, intrauterine device, barrier method).
- •8. Male subjects agree to apply proper birth control and to not donate sperm.
- •9. Male and female subjects agree to continue to use birth control for at least 30 days after the last dose.
- •10. Findings within the range of clinical acceptability in medical history (or the clinical investigator considers the deviation to be irrelevant for the purpose of the study), except signs and symptoms of the accepted associated conditions.
- •11. If on medication to manage endocrine/metabolic conditions, must be on stable doses of medication = 3 months prior to Day 1:
- •a) As anti-diabetic therapy subjects with T2DM may be treated with either diet and exercise alone or e.g. metformin, sulphonylurea, thiazolidinediones, sodium dependent glucose co-transporter (SGLT)2-inhibitors, and bromocriptine quick release (QR) as single agents or combination therapy.
- •b) As lipid-lowering medication subject
排除标准
- •1. Incomplete COVID-19 vaccination during COVID-19 pandemic.
- •2. History of COVID-19 disease with no confirmation of recovery as per Centers for Disease Control and Prevention (CDC) criteria [1].
- •3. Prior (within past 3 months prior to Day 1) or planned treatment with weight loss medications.
- •4. Recent (within past 3 months prior to Day 1) weight gain or loss = 5 kg.
- •5. Prior or planned weight loss surgery for obesity.
- •6. Prior or planned endoscopic treatment for obesity. Examples include:
- •a) Intragastric balloon (e.g. OrberaTM, ReShapeTM, Obalon);
- •b) Natural Orifice Transluminal Endoscopic Surgery (NOTES)/endoscopic oral-assisted bariatric surgery procedures, including but not limited to: restorative obesity surgery, endoluminal (ROSE), StomaphyXTM, duodenojejunal bypass liner (e.g. EndobarrierTM), transoral gastroplasty (e.g., TOGA®),
- •c) endoscopic closure devices (e.g., Apollo OverStitchTM)
- •Patients can be included if the device is removed more than 12 months ago.
- •7. Proven history of bulimia or anorexia nervosa.
- •8. Eating habits consisting of eating relevant amounts of food over the night (after 10 p.m.; except if working on night shifts).
- •9. Prior (within the last 3 months prior to Day 1) or planned treatment with injectable antidiabetic medications (e.g. GLP-1 receptor agonists, insulin).
- •10. Prior (within the last 3 months prior to Day 1) or planned treatment with dipeptidyl peptidase-4 inhibitors.
- •11. Confirmed medical history of cirrhosis.
- •12. NAFLD with cirrhosis (fibrosis score = F4 (= 14 kPa) as determined by screening FibroScanTM).
- •13. Viral hepatitis (Hepatitis B Virus (HBV), HCV.
- •14. Human immunodeficiency virus (HIV) positive.
- •15. Cholestatic disease.
- •16. Alcohol-related liver disease.
- •17. Type I diabetes mellitus.
- •18. HbA1c > 10%.
- •19. Fasting plasma glucose levels > 270 mg/dL.
- •20. Proliferative retinopathy or maculopathy.
- •21. Abnormal liver function tests:
- •a) Alanine transaminase (ALT)/aspartate aminotransferase (AST) = 3x upper limit of normal (ULN)
- •b) Alkaline phosphatase (AP) = 2.5x ULN
- •c) Total bilirubin = 1.5x ULN
- •22. Stage 4 hypertension (SBP = 180 mmHg, DBP = 110 mmHg).
- •23. History or presence of any uncontrolled cardiovascular, pulmonary, hepatobiliary, renal, hematologic, gastrointestinal, endocrinologic, immunologic, dermatologic, neurological, psychiatric, metabolic, musculoskeletal, or malignant disease (except conditions accepted for inclusion which the clinical investigator does not consider a disqualification for participation in the study). History or family history of medullary thyroid cancer. History of pancreatitis. Autoimmune diseases.
- •24. Pregnant (identified by a positive serum pregnancy test) or lactating, or not postmenopausal (no menses for at least 1 year) and of childbearing potential and not using an accepted method of birth control (i.e. surgical sterilization, intrauterine contraceptive device, oral contraceptive, diaphragm, or condom in combination with contraceptive cream, jelly, or foam or abstinence).
- •25. History of illness or behavior (e.g. depression, psychosis) that in the opinion of the investigator might confound the study results or pose additional risk in administering the study procedures.
- •26. Illicit drug abuse (marijuana, amphetamines, barbiturates, cocaine, opiates, phencyclidine and benzodiazepines).
- •27. Alcohol abuse.
- •28. Participation in another investigational drug/biologic or medical device study within 30 days of screening or will be enrolled in another investigation
研究者
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