A 24-week phase 2, double-blind, randomized, placebo-controlled, single-centre safety and efficacy study to evaluate overall safety and tolerability of co-administration of tesofensine and metoprolol in subjects with hypothalamic injury-induced obesity (HIO), and with a 24-week open-label extension, in total 48 weeks

Saniona A/S0 个研究点目标入组 25 人开始时间: 2018年11月28日最近更新: 2021年1月18日

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: Saniona A/S
入组人数: 25

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional clinical trial of medicinal product

入排标准

性别: All

入选标准

•1. Informed consent obtained before any trial-related activities
•2. Males and females, aged 18-75
•3. Confirmed diagnosis of HIO
•4. BMI =27 kg/m2 (where overweight is related to the HIO)
•5. Well managed and stable substitution of hypopituitarism >2 months as judged by the investigator
•6. Normal blood pressure or well managed hypertension (only if dose of BP medication(s) has been stable for >2 months)
•7. Type 2 diabetes is allowed, but the following criteria must be met:
•HbA1c < 86 mmol/mol
•Subjects taking GLP-1 analogues must have been on stable dose for >3 months
•Fasting plasma glucose <11.0 mmol/l measured on site
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 22
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 3

排除标准

•1. BP =160/90 mmHg
•2. HR = 90, <50 bpm
•3. Hypersensitivity to tesofensine/metoprolol or any component of the products
•4. Type 1 diabetes, Cushings disease, acromegaly, hypophysitis, infiltrative diseases or Prader-Willi syndrome
•5. Heart failure New York Heart Association (NYHA) level II or greater, decompensated heart failure
•6. Previous myocardial infarction or stroke within the last 5 years
•7. Diagnosis of schizophrenia, bipolar disorder, personality disorder or other DSM-III disorders, or any other psychiatric condition, which in the investigator’s opinion will interfere significantly with study compliance
•8. Physical impairment, which in the investigator’s opinion will interfere significantly with study compliance
•9. Any clinically significant cardiac arrhythmia
•10. Treatment with calcium channel blockers and beta blockers
•11. Concomitant use of monoaminooxidase inhibitors
•12. Use of recreational medication
•13. Bulimia or anorexia nervosa
•14. Any agent used for weight loss in the past 3 months, except GLP-1 compounds
•15. Untreated hypo- or hyperthyroidism
•16. Clinically significant liver (>3x ULN) and/or kidney impairment
•17. More than 5% weight loss within the last 3 months
•18. Subject is pregnant or lactating or intends to become pregnant or is of childbearing potential and not using an adequate contraceptive method (Spiral or hormonal contraception, birth control pills, implant, transdermal patch, vaginal ring or depot injection)
•19. Male subjects not agreeing to use a condom without spermicide or oil-containing products (e.g., lubricants) during sexual activity with female partners of childbearing potential throughout the trial until at least 8 weeks after the last administration of IMP
•20. Any contraindication for metoprolol according to the Summary of Product Characteristics (SmPC), e.g. severe peripheral arterial disease, untreated pheochromocytoma, concomitant intravenous administration of calcium antagonists of verapamil and diltiazem, due to the risk of hypotension, AV conduction disturbances, or left ventricular insufficiency
•21. Subject has lactose intolerance or a rare hereditary problem of fructose intolerance, glucose galactose malabsorption or sucrase isomaltase insufficiency
•22. Subject is unable to understand and communicate in Danish language or to understand the protocol requirements, instructions and study-related restrictions, the nature, scope and possible consequences of the clinical study or is unlikely to comply with the study requirements; e.g., uncooperative attitude and improbability of completing the clinical study
•23. PHQ-9 (Patient Health Questionnaire):
•a.If a score of at least 5 in question 1 and 2 coming from the area of More than half the days” or Nearly every day” or
•b.PHQ-9 score = 10 when counts from questions 3-5 have been subtracted or
•c.If a tic in question 6 in More than half the days” or Nearly every day” or
•d.Any score > 0 on question 9 at screening and baseline
•24. Any suicidal behaviour within the past 30 days since screening
•25. Subject has been enrolled in another clinical study within the past three months
•26. Any other clinically meaningful condition, which in the opinion of the investigator, would make participation potentially unsafe

研究者

发起方

Saniona A/S

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