Obese Hypogonadotropic HypogonadismPhase 2OHHNCT01200862
Safety and Efficacy of BGS649 in Obese, Hypogonadotropic Hypogonadal Men
A Phase 2 study testing Investigational new drug company code: BGS649 in people with Obese Hypogonadotropic Hypogonadism, run by Mereo BioPharma at 5 sites in 2 countries.
Trial summary
This study is designed as a 2-part study, with Part 1 being open-label to best determine the appropriate dose levels to use in Part 2, which has a randomized, double-blind, placebo controlled design. Read more about this study
- Who is it for?
- Ages 30 to 65 years, men only
- Conditions the study is for
- Obese Hypogonadotropic Hypogonadism
- What is being tested?
- Investigational new drug company code: BGS649
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 29 participants
- Where
- 5 sitesin 2 countries
- Study dates
- Aug 2010to Aug 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males who meet the criteria of obese, hypogonadotropic hypogonadism defined as:
- Patients with a Body Mass Index (BMI) ≥ 30 kg/m2
- Patients with a morning serum total testosterone level < 300 ng/dL on at least two separate occasions during the Screening and/or Baseline periods.
- Patients with inappropriately low gonadotropins at screening given the low testosterone:
- Luteinizing hormone (LH) ≤ ULN
- Follicle stimulating hormone (FSH) ≤ ULN
Show all 12Show fewer
- Estradiol within or above the normal range (defined as ≥ LLN of the approved assay)
- Normal hypothalamic/pituitary function, including:
- Prolactin: within the normal range
- Thyroid stimulating hormone (TSH): within the normal range
- Ferritin: within the normal range
- Patients agree to use a barrier method of contraception (e.g., condom), for the duration of the study and for at least 3 months following their Study Completion visit to prevent BGS649 exposure to their partners.
Who cannot join
- Patients with hypogonadism, not related to obesity or as a result of other underlying issues
- Patients with significant major organ class illness (e.g. kidney or liver disease).
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
United States4 sites
Novartis Investigative Site
Miramar, Florida, 33025
Novartis Investigative Site
San Diego, California, 92120
Novartis Investigative Site
Tucson, Arizona, 85712
Novartis Investigative Site
West Valley City, Utah, 84120
About this study
Official title: An Open-label Dose Finding Study Followed by a Parallel Group, Randomized, Double-blind Study to Evaluate the Safety, Tolerability and Pharmacodynamics of 12 Week BGS649 Treatment in Obese, Hypogonadotropic Hypogonadal Men
This study is designed as a 2-part study, with Part 1 being open-label to best determine the appropriate dose levels to use in Part 2, which has a randomized, double-blind, placebo controlled design. The study aims to assess the safety and tolerability of BGS649, and determine whether or not BGS649 is able to normalize testosterone levels and improve insulin sensitivity in obese, hypogonadotropic hypogonadal (OHH) men
- Conditions
- Obese Hypogonadotropic Hypogonadism
- Being tested
- Investigational new drug company code: BGS649, Placebo
- Keywords
- Obese, obesity, hypogonadism, hypogonadotropic, hyperestrogenemic, testosterone, hypogonadal
- Medical subject headings
- Obesity, Hypogonadism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Investigational new drug company code: BGS649Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| BGS649 (Part 1) | Experimental | BGS649 1mg and 0.1mg in hard gelatin capsules. In part 1 there was individualised dosing to titrate the subject's testosterone into the normal range. If the dose was lower than 0.1mg then specific instructions for dilution of an oral solution of BGS649 were provided. Receives: Drug: Investigational new drug company code: BGS649 |
| Placebo to BGS649 (Part 2) | Placebo comparator | Matching placebo to BGS649 (0.3 and 0.1mg). 0.3mg placebo capsule given on Day 1 and 0.1mg placebo capsule on other treatment visits (week 1 to 11). Receives: Drug: Placebo |
| BGS649 (Part 2) | Experimental | 0.3 or 0.1mg hard gelatin capsules of BGS649 given orally. 0.3mg on Day 1 and 0.1 on all other treatment visits (week 1 to 11). Receives: Drug: Investigational new drug company code: BGS649 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Patients Achieving Normal Testosterone Levels
Percentage of patients achieving normal testosterone (2.50 - 9.50 ng/mL) levels at Week 4 and Week 12
Measured: At Week 4 and 12
Part 2: Change From Baseline at Homeostatic Model Assessment of Insulin Resistance (HOMA-IR & QUICKI Scores) at Week 4 and 12
Pharmacodynamic change from baseline in HOMA-IR. Score at week 4 and week 12 as an assessment of insulin resistance. Low score representing high insulin sensitivity and a high score representing low insulin sensitivity or insulin resistance. HOMA-IR is a ration of Fasting insulin (mIU/L) : Fasting glucose (mmol). Pharmacodynamic change in QUICKI score at week 4 and week 12 as an assessment of insulin resistance. The QUICKI scale is a log score and a high score representing high insulin sensitivity and low score indicating low insulin sensitivity. Patients with a score below 0.3 are considered diabetic. Week 12 data is missing because there were inaccuracies in dosing of patients and so the study was terminated, only safety data was collected.
Measured: Baseline, Week 4 and Week 12
Secondary outcomes (4)
Part 2: Area Under the Concentration-time Curve From Time Zero to Time 't' (AUC0-168)
PK sampling was performed at 0hr (pre-dose), 1 hr, 8 hr, 24 hr, 72 hr, and 168 hr on the following occasions Week 1, Week 4 and week 11. The AUC 0-168 measures the amount of drug within the subjects blood over the 168h post-dosing at these timepoints.
Measured: 11 weeks
Part 2: Pharmacokinetics of BGS649: Maximum (Peak) Observed Blood Drug Concentration After Single Dose Administration (Cmax)
PK sampling was performed at 0hr (pre-dose), 1 hr, 8 hr, 24 hr, 72 hr, and 168 hr on the following occasions Week 1, Week 4 and week 11.
Measured: Week 1 to Week 11
Part 2: Pharmacokinetics of BGS649: Time to Reach Maximum (Peak) Blood Drug Concentration After Single Dose Administration (Tmax)
PK sampling was performed at 0hr (pre-dose), 1 hr, 8 hr, 24 hr, 72 hr, and 168 hr on the following occasions Week 1, Week 4 and week 11.
Measured: Week 1 to Week 11
PK of BGS649 Elimination Half-life Associated With the Terminal Slope of a Semi Logarithmic Concentration-time Curve (T1/2)
PK sampling was performed at 0hr (pre-dose), 1 hr, 8 hr, 24 hr, 72 hr, and 168 hr on the following occasions Week 1, Week 4 and week 11.
Measured: Week 1 to Week 11
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2010 (estimated)
- Study startAug 2010
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Obese Hypogonadotropic HypogonadismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mereo BioPharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Novartis
- Responsible party
- Sponsor
- Investigators
- Jacqueline Parkin, PhD FRCP, Study director, Mereo BioPharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01200862
- Sponsor's protocol ID
- CBGS649A2204
- Acronym
- OHH
- Status last verified
- Oct 2020
- First submitted
- 10 Sep 2010
- Last updated
- 8 Oct 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Dose Finding Study Followed by a Parallel Group, Randomized, Double-blind Study to Evaluate the Safety, Tolerability and Pharmacodynamics of 12 Week BGS649 Treatment in Obese, Hypogonadotropic Hypogonadal Men
- ClinicalTrials.gov ID
- NCT01200862
- Acronym / sponsor ID
- OHH / CBGS649A2204
- Conditions
- Obese Hypogonadotropic Hypogonadism
- Keywords
- Obese, obesity, hypogonadism, hypogonadotropic, hyperestrogenemic, testosterone, hypogonadal
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Mereo BioPharmaIndustry (pharma, biotech, devices)
- Collaborators
- Novartis
- Study start
- Aug 2010
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 14 Sep 2010 (estimated)
- Results
- Posted 8 Oct 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed as a 2-part study, with Part 1 being open-label to best determine the appropriate dose levels to use in Part 2, which has a randomized, double-blind, placebo controlled design. The study aims to assess the safety and tolerability of BGS649, and determine whether or not BGS649 is able to normalize testosterone levels and improve insulin sensitivity in obese, hypogonadotropic hypogonadal (OHH) men
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BGS649 (Part 1) | Experimental | Drug: Investigational new drug company code: BGS649BGS649 1mg and 0.1mg in hard gelatin capsules. In part 1 there was individualised dosing to titrate the subject's testosterone into the normal range. If the dose was lower than 0.1mg then specific instructions for dilution of an oral solution of BGS649 were provided. |
| Placebo to BGS649 (Part 2) | Placebo comparator | Drug: PlaceboMatching placebo to BGS649 (0.3 and 0.1mg). 0.3mg placebo capsule given on Day 1 and 0.1mg placebo capsule on other treatment visits (week 1 to 11). |
| BGS649 (Part 2) | Experimental | Drug: Investigational new drug company code: BGS6490.3 or 0.1mg hard gelatin capsules of BGS649 given orally. 0.3mg on Day 1 and 0.1 on all other treatment visits (week 1 to 11). |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Males who meet the criteria of obese, hypogonadotropic hypogonadism defined as:
- Luteinizing hormone (LH) ≤ ULN
- Follicle stimulating hormone (FSH) ≤ ULN
- Estradiol within or above the normal range (defined as ≥ LLN of the approved assay)
- Prolactin: within the normal range
Key exclusion criteria (3 listed)
- Patients with hypogonadism, not related to obesity or as a result of other underlying issues
- Patients with significant major organ class illness (e.g. kidney or liver disease).
- Other protocol-defined inclusion/exclusion criteria may apply
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Investigational new drug company code: BGS649 | Drug | BGS649 (Part 1), BGS649 (Part 2) |
| Placebo | Drug | Placebo to BGS649 (Part 2) |
Primary outcome
Percentage of Patients Achieving Normal Testosterone Levels
Time frame: At Week 4 and 12
Percentage of patients achieving normal testosterone (2.50 - 9.50 ng/mL) levels at Week 4 and Week 12
Part 2: Change From Baseline at Homeostatic Model Assessment of Insulin Resistance (HOMA-IR & QUICKI Scores) at Week 4 and 12
Time frame: Baseline, Week 4 and Week 12
Pharmacodynamic change from baseline in HOMA-IR. Score at week 4 and week 12 as an assessment of insulin resistance. Low score representing high insulin sensitivity and a high score representing low insulin sensitivity or insulin resistance. HOMA-IR is a ration of Fasting insulin (mIU/L) : Fasting glucose (mmol). Pharmacodynamic change in QUICKI score at week 4 and week 12 as an assessment of insulin resistance. The QUICKI scale is a log score and a high score representing high insulin sensitivity and low score indicating low insulin sensitivity. Patients with a score below 0.3 are considered diabetic. Week 12 data is missing because there were inaccuracies in dosing of patients and so the study was terminated, only safety data was collected.
4 secondary outcomes
Part 2: Area Under the Concentration-time Curve From Time Zero to Time 't' (AUC0-168)
Time frame: 11 weeks
Part 2: Pharmacokinetics of BGS649: Maximum (Peak) Observed Blood Drug Concentration After Single Dose Administration (Cmax)
Time frame: Week 1 to Week 11
Part 2: Pharmacokinetics of BGS649: Time to Reach Maximum (Peak) Blood Drug Concentration After Single Dose Administration (Tmax)
Time frame: Week 1 to Week 11
PK of BGS649 Elimination Half-life Associated With the Terminal Slope of a Semi Logarithmic Concentration-time Curve (T1/2)
Time frame: Week 1 to Week 11
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jacqueline Parkin, PhD FRCP study director
Mereo BioPharma
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Investigational new drug company code: BGS649 in people with Obese Hypogonadotropic Hypogonadism, run by Mereo BioPharma at 5 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Patients Achieving Normal Testosterone Levels (time frame: At Week 4 and 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2020.