NL-OMON52023撤回3 期
foresiGHt: A multicenter, randomized, parallel-arm, placebo- controlled (double- blind) and active-controlled (open-label) trial to compare the efficacy and safety of once-weekly lonapegsomatropin with placebo and a daily somatropin product in adults with growth hormone deficiency - foresiGHt
适应症
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 入组人数
- 32
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
- 年龄范围
- 18 至 64（—）
入选标准
- •1. Age between 23 and 75 years, inclusive, at screening.
- •2. AGHD Diagnosis Criteria
- •For adult-onset AGHD: documented history of structural hypothalamic-pituitary
- •disease, hypothalamic-pituitary surgery, cranial irradiation, 1-4 non-GH
- •pituitary hormone deficiencies, a proven genetic cause of GHD, or traumatic
- •brain injury (TBI).
- •Subjects with childhood-onset GHD must have had GH axis re assessed at final
- •In subjects with TBI as a cause of GHD, GHD must be confirmed by GH stimulation
- •testing performed at least 12 months after the injury.
- •For all subjects, documentation of test results must be available before
- •randomization. Stimulation test protocols and results are subject to review and
- •approval by the Medical Monitor.
- •A. For all countries except Japan: Subjects must satisfy at least one of the
- •following criteria:
- •a. Insulin tolerance test: peak GH <=5 ng/mL
- •b. Glucagon stimulation test according to body mass index (BMI)
- •i. BMI <=30 kg/m2: peak GH <=3 ng/mL
- •ii. BMI >30 kg/m2: peak GH <=1 ng/mL
- •c. Three or four pituitary axis deficiencies (ie, adrenal, thyroid, gonadal,
- •and/or vasopressin; not including GH) with IGF-1 SDS <= -2.0 at screening as
- •measured by central laboratory,
- •d. Macimorelin test: peak GH <=2.8 ng/mL
- •e. Growth hormone-releasing hormone (GHRH) + arginine test according to BMI:
- •i. BMI <25 kg/m2, peak GH <11 ng/mL
- •ii. BMI >=25-<=30 kg/m2, peak GH <8 ng/mL
- •iii. BMI >30 kg/m2, peak GH <4 ng/mL
- •B. For Japan only: Subjects with adult-onset AGHD and deficiency of one or more
- •other pituitary hormones need to satisfy at least one of the following
- •criteria, while subjects with isolated GHD and no evidence of intracranial
- •structure disorder (structural hypothalamic-pituitary disease) or with
- •adult-onset AGHD without deficiency of other pituitary hormones need to satisfy
- •at least 2 of the following criteria:
- •a. Insulin tolerance test: peak GH <=1.8 ng/mL
- •b. Glucagon test: peak GH <=1.8 ng/mL
- •c. Growth Hormone-Releasing Peptide-2 (GHRP-2) tolerance test: peak GH <=9 ng/mL
- •3. IGF-1 SDS <= -1.0 at screening as measured by central laboratory.
- •4. hGH treatment-naïve or no exposure to hGH therapy or GH secretagogue for at
- •least 12 months prior to screening.
- •5. For subjects on hormone replacement therapies for any hormone deficiencies
- •other than GH (eg, adrenal, thyroid, estrogen, testosterone) must be on
- •adequate and stable doses for >=6 weeks prior to and throughout screening.
- •6. For subjects not on glucocorticoid replacement therapy, documentation of
- •adequate adrenal function at screening defined as: morning (6:00-10:00AM) serum
- •cortisol >15.0 ng/mL (measured at central laboratory) and/or
- •Adrenocorticotrophic Hormone (ACTH) stimulation test or ITT with serum cortisol
- •>18.0 ng/mL at or within 26 weeks prior to screening.
- •7. For males not on testosterone replacement therapy: morning (6:00 10:00AM)
- •total testosterone within normal limits for age as measured by the central
- •laboratory at screening.
- •8. On a stable diet and exercise regime at screening with no intention to
- 另有 5 项未显示
排除标准
- •1. Known Prader-Willi Syndrome and/or other genetic diseases that may have an
- •impact on an endpoint; individual cases to be discussed by the Investigator
- •with the Medical Monitor.
- •2. Diabetes mellitus at screening if any of the following criteria are met:
- •a. Poorly controlled diabetes, defined as HbA1c >7.5% at screening according
- •to central laboratory
- •b. Diabetes mellitus (defined as HbA1c >=6.5% and/or fasting plasma glucose >=126
- •mg/dL and/or plasma glucose >=200 mg/dL two hours after oral glucose tolerance
- •test) diagnosed <26 weeks prior to screening
- •c. Change in diabetes regimen (includes dose adjustment) within <90 days
- •prior and throughout screening
- •d. Use of any diabetes drugs other than metformin and/or DPP 4 inhibitors for a
- •cumulative duration of greater than 4 weeks within 12 months prior to screening
- •e. Diabetes-related complications at screening (ie, nephropathy as judged by
- •the investigator, neuropathy requiring pharmacological treatment, retinopathy
- •stage 2 / moderate and above within 90 days prior to screening or during
- •3. Active malignant disease or history of malignancy. Exceptions to this
- •exclusion criterion:
- •a. Resection of in situ carcinoma of the cervix uteri
- •b. Complete eradication of squamous cell or basal cell carcinoma of the skin
- •c. Subjects with GHD attributed to treatment of intracranial malignant tumors
- •or leukemia, provided that a recurrence-free survival period of at least 5
- •years prior to screening is documented in the subject*s file based on a
- •Magnetic Resonance Imaging (MRI) result
- •4. Evidence of growth of pituitary adenoma or other benign intracranial tumor
- •within the last 12 months before screening.
- •5. Subjects with acromegaly without remission / with documented remission less
- •than 24 months prior to screening.
- •6. Subjects with Cushing*s disease without remission / with documented
- •remission less than 24 months prior to screening.
- •7. Subjects with prior cranial irradiation or hypothalamic-pituitary surgery:
- •the procedure took place less than 12 months prior to screening.
- •8. Any disease or condition that, in the judgement of the investigator, may
- •make the subject unlikely to comply with the requirements of the trial or any
- •condition that presents undue risk from the investigational product or
- •procedures.
- •9. Participation in another interventional clinical trial involving an
- •investigational compound within 26 weeks prior to screening or in parallel to
- •this trial.
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