EUCTR2021-000146-18-SE进行中（未招募）1 期
A Phase 2b, Double-blind, Randomized, Placebo-controlled, Dose finding, Multi-center, 36-week Safety and Efficacy Study with Open-label Extension Period of Tesomet in Subjects with Hypothalamic Obesity
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
- 104
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. Subject and, if applicable, their parent or legal guardian must be willing to sign and receive a copy of the informed consent form (ICF) after the nature and risk of study participation have been fully explained
- •Note: Subjects under the age of consent should provide written assent with a written consent provided by a guardian, as per local requirements.
- •2. Female and male subjects >= 16 years of age at the time of informed consent
- •3. Female subjects of non-childbearing potential (WONCBP) defined as: prior menarche, postmenopausal (no menses for 12 months without
- •an alternative medical cause and FSH > 30mIU/ml at screening), permanently sterile (permanent sterilization methods include hysterectomy, or bilateral salpingectomy and bilateral oophorectomy =6 months prior to the first dose of study drug);
- •4. Female subjects who have a confirmed diagnosis (prior to screening) of hypogonadotropic hypogonadism as determined and documented by low estradiol, low FSH, low LH, and amenorrhea. If premenopausal the diagnosis should be confirmed at a time point prior to initiating treatment with estradiol/gestagen. Postmenopausal women with hypogonadotropic hypogonadism must have amenorrhea and low FSH and low LH for 1 year.
- •5. Diagnosis of HO secondary to damage to the hypothalamus
- •Note: Diagnosis of HO secondary to damage to the hypothalamus includes suprasellar tumor, suprasellar surgery, traumatic injury, or irradiation (focal or local), confirmed by medical history documenting temporal relationship between damage and increase in body weight and substantiated as applicable by imaging visualizing tumor, description of surgical procedure, description of radiation therapy, and need for hormone replacement therapy
- •6. At least 6 months since completion of therapy (chemotherapy, surgery, or radiation with resulting injury to the hypothalamus and/or the pituitary) with stable disease and lack of recurrence
- •7. Body mass index (BMI; body weight [kg] / height [m2]) of 30.0 to 60.0 kg/m2, inclusive, at Screening
- •8. Documented stable body weight (gain/loss <10%) for at least 90 days prior to Screening
- •9. Stable and well-managed pituitary replacement (eg, glucocorticoid, thyroid hormone, estrogen/progestin or testosterone, desmopressin, or growth hormone) for >2 months prior to Screening, as judged by the Investigator
- •10. Type 2 diabetes mellitus (T2DM) is allowed, provided that all of the following criteria are met:
- •a. Hemoglobin A1c (HbA1c) <8.5% at Screening; and
- •b. Subjects being treated for T2DM must have been on a stable dose of anti-diabetic medication for ?90 days prior to Screening
- •11. Female subjects of childbearing potential must have a negative serum pregnancy test at Screening and a negative urine pregnancy test at Baseline
- •12. Female subjects of childbearing potential and male subjects must be willing to use a highly effective form of birth control from Screening until 90 days after their last dose of study drug;
- •13. Male subjects must agree not to donate sperm from the first dose of study drug until 90 days after the last dose of study drug
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 40
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 60
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 4
排除标准
- •1.Genotypic cytochrome CYP2D6-poor metabolizers and CYP2D6 ultra-rapid metabolizers, as confirmed by central laboratory at Screening
- •2.Use of any prohibited medication
- •3.Sitting BP that meets the following criteria after 5 minutes of rest at Screening:
- •a.Subjects with systolic BP >145 mmHg or <100 mmHg; or b.Subjects with diastolic BP >95 mmHg or <70 mmHg;
- •4.HR >95 bpm or <50 bpm at Screening and Baseline;
- •5.Corrected QT interval using Fridericia’s formula >450 msec for males and >470 msec for females at Screening based on central review
- •6.Hypersensitivity or contraindication to tesofensine or metoprolol
- •7.Type 1 diabetes mellitus
- •8.History of clinically significant cardiac disorders as determined by the Investigator
- •9.Medical history of stroke or transient ischemic attack
- •10.Subjects who experienced any of the following clinical symptoms or conditions within 90 days prior to Screening, as described by the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) and clinical judgment supported by the Brief Psychiatric Rating Scale (BPRS) administered centrally:
- •a.Delusions; b.Hallucinations; c.Major depressive disorder; d.Hypomania; or e.Suicidality;
- •11.Subjects who answer yes” to the self-mutilation/self-injury question in the Columbia-Suicide Severity Rating Scale (C-SSRS) at Screening and/or Baseline
- •12.Physical impairment which, in the Investigator’s opinion, will interfere significantly with study compliance
- •13.History of bulimia or anorexia nervosa
- •14.Uncontrolled endocrine disorders
- •15.Underlying liver impairment as evidenced by abnormal liver function test results at Screening, including alanine aminotransferase or aspartate aminotransferase abnormalities >3 x the upper limit of normal (ULN), or total bilirubin >1.5 x ULN (except in cases of diagnosed Gilbert’s Syndrome)
- •16.Underlying kidney impairment, defined as estimated glomerular filtration rate <= 60 mL/min/1.73 m2 (using the Schwartz equation), as determined by Screening laboratory assessments performed by the central laboratory
- •17.Subject has a rare hereditary problem of fructose intolerance, glucose galactose malabsorption, or sucrase-isomaltase insufficiency;
- •18.Subject without sufficient comprehension, communication ability, and cooperation to enable compliance with the study procedures and assessments
- •19.Subject who, in the Investigator’s judgment, is actively suicidal and therefore deemed to be at significant risk for suicide, or:
- •a. Subjects who answer yes to Question 4 of the C-SSRS on the Suicidal Ideation portion and the ideation occurred within 6 months prior to screening; or
- •b. Subjects who answer yes to Question 5 of the C-SSRS on the Suicidal Ideation portion and the ideation occurred within 6 months prior to screening; or
- •c. Subjects who answer yes to any of the suicide-related behaviors on the Suicidal Behavior portion of and the behavior occurred within 2 years prior to Screening
- •20.Subjects with a history of substance abuse, including cannabinoids and/or alcohol use disorders, as per DSM-5, or a positive urine drug test (including amphetamines, cocaine, opiates, phencyclidine, tetrahydrocannabinol, barbiturates, and benzodiazepines) at Screening
- •21.Participation in another interventional study (eg, of a drug, over-the-counter product, device, weight loss program, therapy) within 90 days prior to Screening or any prior participation in a tesofensine or Tesomet clinical study)
- •22.Subjects who have a co-existing medical con
研究者
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