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    Summary
    EudraCT Number:2015-005760-42
    Sponsor's Protocol Code Number:MBGS205
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-03-29
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2015-005760-42
    A.3Full title of the trial
    A Phase IIb multicentre, double-blind, dose-ranging, randomised, placebo-controlled study evaluating safety and efficacy of BGS649 in male obese subjects with hypogonadotropic hypogonadism
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A trial to determine the how safe and effective the test drug is for obese males with hypogonadotropic hypogonadism. The trial is blinded and the subjects may be given the test drug or a placebo.
    A.4.1Sponsor's protocol code numberMBGS205
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorMereo BioPharma 2 Limited
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportMereo BioPharma 2 Ltd
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationICON Clinical Research
    B.5.2Functional name of contact pointProject management
    B.5.3 Address:
    B.5.3.1Street Address79 T.W. Alexander Drive , 4401 Research Commons Bldg Suite 300, PO Box 1435
    B.5.3.2Town/ cityDurham, NC
    B.5.3.3Post code27709 - 4353
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1 215 616 4914
    B.5.6E-mailCharles.Hayward@iconplc.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.2Product code BGS649
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNot established
    D.3.9.1CAS number 143030-47-1
    D.3.9.2Current sponsor codeBGS649
    D.3.9.3Other descriptive nameFluor-DCP-triazol
    D.3.9.4EV Substance CodeSUB121119
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.1
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.2Product code BGS649
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNot established
    D.3.9.1CAS number 143030-47-1
    D.3.9.2Current sponsor codeBGS649
    D.3.9.3Other descriptive nameFluor-DCP-triazol
    D.3.9.4EV Substance CodeSUB121119
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1.0
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, hard
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Hypogonadotropic hypogonadism (HH)
    E.1.1.1Medical condition in easily understood language
    Hypogonadotropic hypogonadism (HH) is a gonadotropin-releasing hormone deficiency which may cause obesity, low libido and infertility.
    E.1.1.2Therapeutic area Body processes [G] - Reproductive physiologi cal processes [G08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10021012
    E.1.2Term Hypogonadotrophic hypogonadism
    E.1.2System Organ Class 100000004860
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective is to demonstrate the efficacy of BGS649 to normalise total testosterone levels (300-1000 ng/dL [10.4-35 nmol/L]) in ≥ 75% of subjects after 24 weeks of treatment.
    E.2.2Secondary objectives of the trial
    Secondary Objectives
    1. To follow the time-course of normalisation in total testosterone levels
    2. To demonstrate the efficacy of BGS649 to normalise total testosterone levels in ≥ 90% of subjects after 24 weeks of treatment
    3. To evaluate the effect of BGS649 on luteinising hormone (LH) and follicle stimulating hormone (FSH)
    4. To further determine the pharmacokinetics (PK) of BGS649.

    Safety Objectives:
    1. To evaluate safety and tolerability of BGS649.

    Exploratory Objectives:
    1. To evaluate the effect of BGS649 on oestradiol, DHT and inhibins (A and B)
    2. To evaluate the effect of BGS649 on testosterone/oestradiol ratio
    3. To investigate patient reported outcomes (PROs) following treatment with BGS649. Evaluated PROs will include:
    - Sexual function (IIEF & PROMIS SexFS)
    - Energy/fatigue (Brief Fatigue Inventory [BFI])
    - SF-36 Quality of life (QoL) questionnaire
    - Patient Global Impression (PGI-S)

    For additional Exploratory Objectives refer to the protocol
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Adult male subject aged 18 to 65 years inclusive
    2. BMI > 30 kg/m2 and < 50 kg/m2
    3. Serum total testosterone concentration below the normal range (serum total testosterone < 300 ng/dL [< 10.4 nmol/L]) in both of two morning samples, taken before 11:00 am, at least 3 days apart
    4. LH levels below the upper limit of normal (ULN)
    5. Oestradiol levels within or above the normal range of approved assay
    6. At least two symptoms of androgen deficiency present for at least 2 months prior to the first Screening Visit, with at least one of these being a sexual dysfunction
    7. Agreement on the part of the subjects to use double-barrier contraception for vaginal sexual intercourse with female partners of child bearing potential to prevent conception and theoretical fetal risk of BGS649 exposure from seminal fluid. To use single barrier protection (condom) to prevent semen exposure through non-vaginal sexual intercourse with female partners of child bearing potential and refrain from sperm donation for the duration of the study. All to be continued for at least 3 months following study drug discontinuation.
    8. Ability to understand and comply with the requirements of the protocol/study, including understanding and being able to give informed consent.
    E.4Principal exclusion criteria
    1. Evidence of clinically significant endocrinopathy at Screening that may interfere with the study assessments or mask/mimic symptoms of hypogonadism e.g., growth hormone deficiency, adrenal deficiency, untreated hypothyroidism (primary hypothyroidism on replacement with normal thyroid stimulating hormone [TSH] level is allowed), or that may interfere with the evaluation of efficacy/safety parameters
    2. Other types of HH (e.g., Kallmann syndrome) or primary hypogonadism (e.g., cryptorchidism, or Klinefelter syndrome)
    3. Any other pituitary or hypothalamic disease, as based on one of the following:
    - Current or past hypothalamic or pituitary tumour
    - Suspicion of pituitary or hypothalamic tumour based on a clinical or laboratory evidence, e.g., elevated prolactin or other pituitary hormone abnormality, symptoms/signs of tumour mass effect, very low testosterone and LH (unless there is documentation of a normal magnetic resonance imaging scan of pituitary and hypothalamus within 3 months before first Screening Visit)
    - Hypothalamic or pituitary conditions, which may contribute to hypogonadism e.g., pituitary sarcoidosis, histiocytosis or tuberculosis
    4. Subject with prostate disease, as confirmed by the presence of one of the following:
    - History of prostate cancer
    - Elevated PSA levels ≥ 3 ng/mL at Screening
    - Subjects with a detectable prostate nodule or induration at Screening unless proven previously benign by a biopsy
    - Urologist confirmed symptomatic benign prostatic hyperplasia
    5. History of type 1 diabetes mellitus
    6. Current clinical diagnosis of depression or current or past Bipolar disorder
    7. Uncontrolled type 2 diabetes mellitus (HbA1c > 10.5% at Screening) or significant diabetic neuropathy. Subjects with type 2 diabetes can be included when both of the following conditions are met:
    - HbA1c ≤ 10.5% at Screening, and:
    - Anti-diabetic medication regimen (excluding insulin) has been stable for ≥ 8 weeks before the first Screening visit
    8. Treatment with one or more of the following prescribed or over the counter medications in the six months prior to first Screening Visit:
    - Medications with known androgenic or estrogenic properties or known to affect production of sex hormones
    - Injectable testosterone enhancement therapy
    - Fertility drugs
    - Growth hormone
    - Anabolic steroids
    - Long acting opiates
    9. Treatment with topical testosterone therapy in the two months prior to first Screening Visit
    10. Treatment with one of the following medications for either >7 consecutive days in the three months prior to first Screening Visit OR any treatment within 3 weeks of first Screening Visit:
    - Testosterone lowering drugs e.g., spironolactone, cimetidine, 5α-reductase inhibitors
    - Short acting opiates / opioids including methadone
    - Medications known to increase prolactin levels, e.g., antipsychotics
    11. Treatment with the following medications:
    - Chronic systemic steroid treatment or systemic steroids for > 5 consecutive days for intercurrent illness within the 4 weeks prior to the first Screening visit (inhaled and topical steroids are allowed)
    - Clomid within 1 year before first Screening Visit
    - Biphosphonates or other medication used to treat low bone density (denosumab, teriparatide) except calcium and vitamin D within 1 year before first Screening Visit
    12. Weight loss or weight gain (gain or loss > 5% body weight) OR weight reduction surgery or procedure within the 3 months prior to first Screening Visit
    13. Participation in any clinical trial using clinical investigational product intervention within 3 months before first Screening Visit or 5 half-lives of investigational product administration, whichever is longer
    14. Any clinically significant 12-lead ECG abnormalities at Screening including corrected QT interval by Fridericia’s correction method (QTCF) > 450 ms
    15. Medical history of Long QT syndrome
    16. History of thromboembolic disease
    17. Grade ≥ 3 lower extremity oedema
    18. Use of cardiac pacemaker or other medical electronic devices that can be affected by bioimpedance assessment

    Refer to the protocol for additional exclusion criteria.
    E.5 End points
    E.5.1Primary end point(s)
    1. Normalisation of total testosterone levels in ≥ 75% of subjects at Week 24.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 24
    E.5.2Secondary end point(s)
    Secondary
    1. Proportion of subjects that have normalisation of total testosterone to Week 24
    2. Proportion of subjects that overshoot testosterone (total testosterone above 1000 ng/dL [35 nmol/L]) to Week 24
    3. Normalisation of total testosterone in ≥ 90% subjects to Week 24
    4. Change of LH and FSH at 24 weeks
    5. Population PK analysis of plasma BGS649 concentrations
    6. PK analysis of semen BGS649 concentrations.

    Exploratory
    1. Change in oestradiol, inhibins (A and B) levels and DHT
    2. Change in testosterone/oestradiol ratio
    3. Body composition changes at Week 12 and Week 24
    4. Changes in markers of cardiometabolic disease: blood pressure, lipid profile, HbA1c, glucose and insulin, hs-CRP and HOMA-IR and association with change in body composition and testosterone level.
    5. Change in markers of bone turnover in those with and without 25 hydroxy vitamin D deficiency
    6. Change in total and domain scores on PRO measures (IIEF, PROMIS SexFS: to assess sexual function; BFI, PROMIS Fatigue Short Form, SF-36 - Vitality: to assess energy levels and fatigue; SF-36: to assess general quality of life (QoL); PGI-S: to assess the patients’ impression of their current health status) over the 24 week period.
    7. Change in physical activity, sleeping pattern and strength measured by wrist worn monitors and grip strength measurement at 12 and 24 weeks and association with body composition (as measured by BMI and waist circumference and impedance) and testosterone level.
    8. PK/pharmacodynamic (PD) relationship between BGS649 concentrations and testosterone levels
    9. For semen analysis: change in semen parameters throughout the study and association with LH/FSH level
    10. Change in bioavailable testosterone
    11. Time to first normal testosterone level.

    Safety
    1. Treatment emergent AEs (TEAEs)/SAEs (from first dose of study drug until 90 days after last treatment dose)
    2. Change in PSA during 24 week treatment duration
    3. Change in haematocrit during 24 week treatment duration
    4. Change in Bone Mineral Density (DEXA scan T-score and density in g/cm3) from Screening and bone turnover biomarkers at 24-weeks from Baseline
    5. Change in vital signs and clinical laboratory parameters, ECG
    6. Change in physical examination (including general, prostate, breast and oedema of the lower extremities).
    E.5.2.1Timepoint(s) of evaluation of this end point
    As per protocol
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial4
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA25
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Italy
    Spain
    Sweden
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days10
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days10
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 268
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female No
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state22
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 120
    F.4.2.2In the whole clinical trial 268
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Some subjects who complete 24 weeks of treatment will be invited to participate in a 6-month blinded safety extension study (Protocol MBGS206).
    All other subjects - None
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2016-05-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-05-25
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-02-15
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