Hypogonadotropic HypogonadismPhase 2NCT02908074

A 6 Month Safety Extension Study of MBGS205

A Phase 2 study testing BGS649 in people with Hypogonadotropic Hypogonadism, run by Mereo BioPharma at 37 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Phase IIb, multicentre, double-blind, randomised, placebo-controlled parallel-group 36-week study evaluating safety and efficacy of BGS649 in male obese subjects with hypogonadotropic hypogonadism (HH) Read more about this study

Who is it for?: Ages 18 to 65 years, men only
Conditions the study is for: Hypogonadotropic Hypogonadism
What is being tested?: BGS649
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 143 participants
Where: 37 sitesUnited States
Study dates: 15 Nov 2016to 21 Nov 2018
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 18 to 65 years
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

Participating in Study MBGS205 and completion of the 24 week treatment period without meeting any discontinuation criteria of Study MBGS205
In opinion of the investigator has been compliant with the requirements of the Study MBGS205 protocol.

Who cannot join

-Meeting any of the discontinuation criteria of initial Study MBGS205

Trial locations and contacts

37 sites in 1 country.

City, postcode or hospital

37 sites in 1 country

United States37 sites

Mereo Research Site
Albany, New York
Mereo Research Site
Anaheim, California
Mereo Research Site
Bradenton, Florida
Mereo Research Site
Chandler, Arizona
Mereo Research Site
Charlotte, North Carolina
Mereo Research Site
Dallas, Texas
Mereo Research Site
DeLand, Florida
Mereo Research Site
Elkridge, Maryland
Mereo Research Site
Evansville, Indiana
Mereo Research Site
Fort Myers, Florida
Mereo Research Site
Fort Worth, Texas
Mereo Research Site
Garden City, New York
Mereo Research Site
Great Neck, New York
Mereo Research Site
Greenbrae, California
Mereo Research Site
Henderson, Nevada
Mereo Research Site
Hialeah, Florida
Mereo Research Site
Kenosha, Wisconsin
Mereo Research Site
Las Vegas, Nevada
Mereo Research Site
Lincoln, California
Mereo Research Site
Los Angeles, California
Mereo Research Site
Marrero, Louisiana
Mereo Research Site
Meridian, Idaho
Mereo Research Site
Mobile, Alabama
Mereo Research Site
Mt. Pleasant, South Carolina
Mereo Research Site
Nashville, Tennessee
Mereo Research Site
New York, New York
Mereo Research Site
Norfolk, Virginia
Mereo Research Site
Pearland, Texas
Mereo Research Site
Phoenix, Arizona
Mereo Research Site
Raleigh, North Carolina
Mereo Research Site
Rochester, New York
Mereo Research Site
San Antonio, Texas
Mereo Research Site
San Diego, California
Mereo Research Site
Scottsdale, Arizona
Mereo Research Site
St. Petersburg, Florida
Mereo Research Site
West Jordan, Utah
Mereo Research Site
Winston-Salem, North Carolina

Other trials in United States

About this study

Official title: A 6 Month, Double-blind Safety Extension Study of MBGS205

Read the detailed description

This is a 6 months, active treatment, extension study, open to subjects who have completed full 24 weeks in Study MBGS205 (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 [HH]).The main purpose of Study MBGS206 is to evaluate long term safety and efficacy parameters in subjects after 12 months exposure with BGS649.

Conditions: Hypogonadotropic Hypogonadism
Being tested: BGS649
Keywords: Hypogonadotropic, hypogonadism, testosterone
Medical subject headings: Hypogonadism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BGS649Drug
Also called Leflutrozole
Capsules will be taken weekly for a maximum of 24 weeks

Study groups in NCT02908074
Study group	Role	What they receive
BGS649 0.1 mg	Experimental	Drug: BGS649 Dose 1 weekly Receives: Drug: BGS649
BGS649 0.3 mg	Experimental	Drug: BGS649 Dose 2 weekly Receives: Drug: BGS649
BGS649 1.0 mg	Experimental	Drug: BGS649 Dose 3 weekly Receives: Drug: BGS649

What is being measured

The primary outcome is the main question the study is designed to answer.

Percent Change in Bone Mineral Density Measured by DEXA (g/cm^2) From Baseline in Study MBGS205 to Week 48 in Study MBGS206
Percentage change in lumbar bone mineral density measured by DEXA (g/cm^2) from Baseline in Study MBGS205 to Week 48 in Study MBGS206 by dose group in participants randomised to active treatment in MBGS205.
Measured: At 48 weeks compared to baseline in MBGS205

Secondary outcomes (16)

Percentage Change From Baseline in DEXA Scan Density (g/cm^2) by Location for Subjects Randomised to Active Treatment in Study MBGS205 (Over-read)
Percentage change from baseline in hip (total and femoral neck) bone mineral density measured by DEXA (g/cm^2) from Baseline in Study MBGS205 to Week 48 in Study MBGS206
Measured: 48 Weeks
Descriptive Summary of Percentage Change in Bone Turnover Markers for Subjects Randomised to Active Treatment in Study MBGS205
Percentage change from baseline in bone turnover markers (C-terminal telopeptide [CTx1], osteocalcin, bone alkaline phosphatase, and procollagen type 1 N-propeptide [P1NP]) from Baseline in Study MBGS205 to Week 48 in Study MBGS206
Measured: 48 Weeks
Percentage of Subjects With DEXA Scan T-score ≤ -2.5 at Week 48 by Location
Proportion of subjects with DEXA scan T- scores ≤ -2.5 at Week 48 in MBGS206 compared to baseline in MBGS205 by body location (using overread scan images).
Measured: 48 Weeks
Percentage Change From Baseline in Bone Mineral Density by Location and Vitamin D Deficiency
Percentage change from baseline in bone density and bone biomarkers for vitamin D deficiency from Baseline in Study MBGS205 to Week 48 in Study MBGS206. Bone mineral density (g/cm^2) measured by DEXA over-read by a central reader.
Measured: 48 Weeks
Change From Baseline of Oestradiol (Absolute) From Baseline in Study MBGS205 to Week 48
Descriptive Summary of Oestradiol and Testosterone/Oestradiol Ratio for Subjects Randomised to Active Treatment in Study MBGS205
Measured: 48 Weeks
Change From Baseline of Oestradiol (Percentage) From Baseline in Study MBGS205 to Week 48
Descriptive Summary of Percentage Change in Oestradiol and Testosterone/Oestradiol Ratio for Subjects Randomised to Active Treatment in Study MBGS205
Measured: 48 Weeks
Analysis of Proportion of Subjects That Overshoot Testosterone for Subjects Randomised to Active Treatment in Study MBGS205
Proportion of subjects that overshoot testosterone (total testosterone above 1000 ng/dl [35 nmol/L], from first dose of study drug in Study MBGS205 until study completion)
Measured: 48 Weeks
Change From Baseline in PSA From Baseline in Study MBGS205 to Week 48 in Study MBGS206
Summary of Laboratory Test Results and Change from Baseline: PSA for Subjects Randomised to Active Treatment in Study MBGS205
Measured: 48 Weeks
Change From Baseline in Haematocrit at Week 48
Change from baseline in haematocrit from Baseline in Study MBGS205 to Week 48 in Study MBGS206
Measured: 48 Weeks
Change From Baseline in Blood Pressure From Baseline to Week 48MBGS205
Change from baseline in blood pressure (systolic and diastolic measured in mmHg) Baseline in Study MBGS205 to Week 48 in Study MBGS206.
Measured: 48 Weeks
Percentage of Subjects Achieving Normalisation of Bioavailable (Total) Testosterone at Wk 48
Percentage of subjects where bioavailable testosterone was normalised at week 48 in Study MBGS206. Where normalisation was considered testosterone in the range 300-1000 mg/dL.
Measured: 48 Weeks
Descriptive Summary of Total Testosterone (ng/dL) for Subjects Randomised to Active Treatment in Study MBGS205
Change from baseline in total, free and bioavailable testosterone from Baseline in Study MBGS205 to Week 48 in Study MBGS206
Measured: 48 Weeks
Change From Baseline in Free and Bioavailable Testosterone
Change from baseline in free and bioavailable (total) testosterone from baseline in Study MBGS205 to Week 48 in Study MBGS206.
Measured: 48 Weeks
Change From Baseline in Luteinizing Hormone From Baseline to Week 48
Change from baseline of LH from Baseline in Study MBGS205 to Week 48 in Study MBGS206.
Measured: 48 Weeks
Change From Baseline in Follicle Stimulating Hormone at Week 48
Change from Baseline in Study MBGS205 to Week 48 in Study MBGS206 in follicle stimulating hormone (FSH).
Measured: 48 Weeks
Percentage Change in Bone Alkaline Phosphatase
Percentage change in baseline in alkaline phosphatase from baseline in study MBGS205 to week 48 in MBGS206.
Measured: 48 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Nov 201621 Nov 2018

First posted20 Sep 2016 (estimated)
Study start15 Nov 2016
Primary completion8 Sep 2018
Study completion21 Nov 2018

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 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: 143 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02908074
Sponsor's protocol ID: MBGS206
Status last verified: Apr 2023
First submitted: 12 Sep 2016
Last updated: 18 May 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 18 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A 6 Month, Double-blind Safety Extension Study of MBGS205
ClinicalTrials.gov ID: NCT02908074
Acronym / sponsor ID: MBGS206
Conditions: Hypogonadotropic Hypogonadism
Keywords: Hypogonadotropic, hypogonadism, testosterone
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 143 participants (actual)
Lead sponsor: Mereo BioPharmaIndustry (pharma, biotech, devices)
Study start: 15 Nov 2016 (actual)
Primary completion: 8 Sep 2018 (actual)
Study completion: 21 Nov 2018 (actual)
First posted: 20 Sep 2016 (estimated)
Results: Posted 18 May 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
BGS649 0.1 mg	Experimental	Drug: BGS649Drug: BGS649 Dose 1 weekly
BGS649 0.3 mg	Experimental	Drug: BGS649Drug: BGS649 Dose 2 weekly
BGS649 1.0 mg	Experimental	Drug: BGS649Drug: BGS649 Dose 3 weekly

Who may qualify

Ages: 18 to 65 years
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Participating in Study MBGS205 and completion of the 24 week treatment period without meeting any discontinuation criteria of Study MBGS205
In opinion of the investigator has been compliant with the requirements of the Study MBGS205 protocol.

Key exclusion criteria (1 listed)

-Meeting any of the discontinuation criteria of initial Study MBGS205

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
BGS649Also: LeflutrozoleCapsules will be taken weekly for a maximum of 24 weeks	Drug	BGS649 0.1 mg, BGS649 0.3 mg, BGS649 1.0 mg

Primary outcome

Percent Change in Bone Mineral Density Measured by DEXA (g/cm^2) From Baseline in Study MBGS205 to Week 48 in Study MBGS206
Time frame: At 48 weeks compared to baseline in MBGS205
Percentage change in lumbar bone mineral density measured by DEXA (g/cm^2) from Baseline in Study MBGS205 to Week 48 in Study MBGS206 by dose group in participants randomised to active treatment in MBGS205.

16 secondary outcomes

Percentage Change From Baseline in DEXA Scan Density (g/cm^2) by Location for Subjects Randomised to Active Treatment in Study MBGS205 (Over-read)
Time frame: 48 Weeks
Descriptive Summary of Percentage Change in Bone Turnover Markers for Subjects Randomised to Active Treatment in Study MBGS205
Time frame: 48 Weeks
Percentage of Subjects With DEXA Scan T-score ≤ -2.5 at Week 48 by Location
Time frame: 48 Weeks
Percentage Change From Baseline in Bone Mineral Density by Location and Vitamin D Deficiency
Time frame: 48 Weeks
Change From Baseline of Oestradiol (Absolute) From Baseline in Study MBGS205 to Week 48
Time frame: 48 Weeks
Change From Baseline of Oestradiol (Percentage) From Baseline in Study MBGS205 to Week 48
Time frame: 48 Weeks
Analysis of Proportion of Subjects That Overshoot Testosterone for Subjects Randomised to Active Treatment in Study MBGS205
Time frame: 48 Weeks
Change From Baseline in PSA From Baseline in Study MBGS205 to Week 48 in Study MBGS206
Time frame: 48 Weeks
Change From Baseline in Haematocrit at Week 48
Time frame: 48 Weeks
Change From Baseline in Blood Pressure From Baseline to Week 48MBGS205
Time frame: 48 Weeks
Percentage of Subjects Achieving Normalisation of Bioavailable (Total) Testosterone at Wk 48
Time frame: 48 Weeks
Descriptive Summary of Total Testosterone (ng/dL) for Subjects Randomised to Active Treatment in Study MBGS205
Time frame: 48 Weeks
Change From Baseline in Free and Bioavailable Testosterone
Time frame: 48 Weeks
Change From Baseline in Luteinizing Hormone From Baseline to Week 48
Time frame: 48 Weeks
Change From Baseline in Follicle Stimulating Hormone at Week 48
Time frame: 48 Weeks
Percentage Change in Bone Alkaline Phosphatase
Time frame: 48 weeks

Results and safety

Results posted to the registry on 18 May 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
BGS649 0.1 mg	38	29
BGS649 0.3 mg	33	27
BGS649 1.0 mg	31	25
Placebo to BGS649 0.1 mg	13	10
Placebo to BGS649 0.3 mg	17	13
Placebo to BGS649 1.0 mg	11	7

Primary outcome: Percent Change in Bone Mineral Density Measured by DEXA (g/cm^2) From Baseline in Study MBGS205 to Week 48 in Study MBGS206

Time frame: At 48 weeks compared to baseline in MBGS205. Mean (Standard Deviation). Unit: Percentage change

Measure	BGS649 0.1 mg n = 21	BGS649 0.3 mg n = 16	BGS649 1.0 mg n = 16
Value	-2.24 (3.157)	-3.31 (5.301)	-1.68 (3.095)

Population analysed: The Intention-to-treat (ITT) population included all participants who: were randomised, and received at least 1 dose of study medication, and provided a Baseline lumbar spine bone mineral density (BMD) measure in MBGS205 and at least one available evaluation of lumbar spine post-Baseline in MBGS206. Here, the "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure.

16 secondary outcomes are reported in the full results.

Adverse events

Time frame: Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
BGS649 0.1 mg	1 of 38 (2.6%)	27 of 38 (71.1%)	0 of 38
BGS649 0.3 mg	2 of 33 (6.1%)	23 of 33 (69.7%)	1 of 33
BGS649 1.0 mg	1 of 30 (3.3%)	25 of 30 (83.3%)	0 of 30
Placebo to BGS649 0.1 mg	0 of 13 (0%)	10 of 13 (76.9%)	0 of 13
Placebo to BGS649 0.3 mg	0 of 17 (0%)	12 of 17 (70.6%)	0 of 17
Placebo to BGS649 1.0 mg	0 of 10 (0%)	6 of 10 (60%)	0 of 10

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Hugh Jones principal investigator

Barnsley Hospital NHS Foundation Trust

37 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BGS649 in people with Hypogonadotropic Hypogonadism, run by Mereo BioPharma at 37 sites in United States.

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 2 inclusion and 1 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: finished, as of the sponsor's last update on 18 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 37 sites in United States. 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. 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 18 May 2023). 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?

Percent Change in Bone Mineral Density Measured by DEXA (g/cm^2) From Baseline in Study MBGS205 to Week 48 in Study MBGS206 (time frame: At 48 weeks compared to baseline in MBGS205). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02908074.

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 18 May 2023.