Hypogonadotropic HypogonadismPhase 2NCT02730169

Safety and Efficacy of BGS649 in Male Obese Subjects With Hypogonadotropic Hypogonadism

A Phase 2 study testing BGS649 in people with Hypogonadotropic Hypogonadism, run by Mereo BioPharma at 63 sites in 4 countries.

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

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?: Yes, some participants may receive a placebo
How many people: 271 participants
Where: 63 sitesin 4 countries
Study dates: 12 May 2016to 19 May 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

Adult male subject aged 18 to 65 years inclusive
BMI > 30 kg/m2 and < 50 kg/m2
Serum total testosterone concentration below the normal range
LH levels below the upper limit of normal
Oestradiol levels within or above the normal range of approved assay
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

Who cannot join

Evidence of clinically significant endocrinopathy at screening that may interfere with the study assessments
Other types of hypogonadotropic hypogonadism or primary hypogonadism
Any other pituitary or hypothalamic disease

Trial locations and contacts

63 sites in 4 countries.

Country

City, postcode or hospital

63 sites in 4 countries

United States48 sites

Mereo Research Site
Albany, New York
Mereo Research Site
Anaheim, California
Mereo Research Site
Baltimore, Maryland
Mereo Research Site
Birmingham, Alabama
Mereo Research Site
Bradenton, Florida
Mereo Research Site
Carlsbad, California
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
Gurnee, Illinois
Mereo Research Site
Henderson, Nevada
Mereo Research Site
Hialeah, Florida
Mereo Research Site
Homestead, 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
Meridian, Idaho
Mereo Research Site
Middleburg Heights, Ohio
Mereo Research Site
Mobile, Alabama
Mereo Research Site
Mt. Pleasant, South Carolina
Mereo Research Site
Murray, Utah
Mereo Research Site
Nashville, Tennessee
Mereo Research Site
New Orleans, Louisiana
Mereo Research Site
New York, New York
Mereo Research Site
Norfolk, Virginia
Mereo Research Site
Omaha, Nebraska
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
Smyrna, Tennessee
Mereo Research Site
Spring Hill, Tennessee
Mereo Research Site
St Louis, Missouri
Mereo Research Site
St. Petersburg, Florida
Mereo Research Site
West Jordan, Utah
Mereo Research Site
Winston-Salem, North Carolina

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United Kingdom7 sites

Mereo Research Site
Barnsley
Mereo Research Site
Coventry
Mereo Research Site
Dundee
Mereo Research Site
Edinburgh
Mereo Research Site
Hull
Mereo Research Site
Manchester
Mereo Research Site
Newcastle

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Italy4 sites

Mereo Research Site
Ancona
Mereo Research Site
Parma
Mereo Research Site
Roma
Mereo Research Site
Siena

Other trials in Italy

Spain4 sites

Mereo Research Site
Coslada
Mereo Research Site
Girona
Mereo Research Site
Madrid
Mereo Research Site
Majadahonda

Other trials in Spain

About this study

Official title: 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

The purpose of this study is to evaluate the safety and efficacy of BGS649 in male obese subjects with hypogonadotropic hypogonadism. All subjects will be treated for a maximum of 24 weeks. Some subjects who complete 24 weeks of treatment will be invited to participate in a 6-month blinded safety extension study (Protocol MBGS206). The study is planned to enroll 268 subjects.

Conditions: Hypogonadotropic Hypogonadism
Being tested: BGS649, Placebo
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
Capsules were taken weekly for a maximum of 24 weeks
PlaceboDrug
Capsules were taken weekly for a maximum of 24 weeks

Study groups in NCT02730169
Study group	Role	What they receive
BGS649 0.1 mg	Experimental	BGS649 0.1 mg weekly (1 BGS649 0.1 mg capsule and 2 indistinguishable placebo capsules) Receives: Drug: BGS649
BGS649 0.3 mg	Experimental	BGS649 0.3 mg weekly (3 BGS649 0.1 mg capsules) Receives: Drug: BGS649
BGS649 1.0 mg	Experimental	BGS649 1.0 mg weekly (1 BGS649 1.0 mg capsule and 2 indistinguishable placebo capsules) Receives: Drug: BGS649
Placebo	Placebo comparator	Placebo weekly (3 indistinguishable placebo capsules) Receives: Drug: Placebo

What is being measured

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

Percentage of Patients With Normalised Testosterone After 24 Weeks of Study Treatment
Percentage of patients with normalised testosterone i.e. testosterone in the range 300-1000ng/dL after 24 weeks of study treatment. The primary objective was considered met, if greater than or equal to 75% of the participants in any arm normalised.
Measured: 24 weeks of treatment

Secondary outcomes (7)

The Proportion of Subjects That Have Normalization of Total Testosterone Serum Concentrations From Baseline to Week 24
Normalised total testosterone level was defined as between 300-1000 ng/dL (10.4-35 nmol/L) inclusive. Levels >1000 ng/dL were considered super-physiological outside the normal range.
Measured: Baseline, Day 8, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks and 24 weeks
Proportion of Subjects That Overshoot Testosterone (Total Testosterone Above 1000 ng/dL [35 Nmol/L]) From Baseline to Week 24
Testosterone overshoot was defined as total testosterone above 1000 ng/dL (35 nmol/L). Samples were collected in the morning before 11 am pre dose.
Measured: Baseline, Day 8, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks and 24 weeks
Normalization of Total Testosterone Serum Concentrations in ≥ 90% Subjects After 24 Weeks of Treatment.
Normalized total testosterone level was defined as between 300-1000 ng/dL (10.4-35 nmol/L) inclusive. Levels >1000 ng/dL were considered super-physiological outside the normal range. This secondary outcome measure was considered to have been met for a dose if ≥ 90% of subjects in the intent-to-treat (ITT) population had normalisation of total testosterone levels at Week 24.
Measured: 24 weeks of treatment
Mean (SD) Change From Baseline in Luteinizing Hormone (LH) to Week 24.
LH was measured at screening, baseline. The Baseline was defined as the last non-missing value collected before the first study treatment administration, including unscheduled assessments.
Measured: Day 8, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks and 24 weeks
Mean (SD) Change From Baseline in Follicle Stimulating Hormone (FSH) to Week 24.
FSH was measured at baseline, Visit 1 through 8 and follow-up. Baseline was defined as the last non-missing value collected before the first study treatment administration, including unscheduled assessments.
Measured: Day 8, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks and 24 weeks
Descriptive Summary (Geometric Mean [95% CI]) of BGS649 Plasma PK Concentration Values to 24 Weeks.
Plasma PK sampling for BGS649 was performed at Weeks 12 and 24. BGS649 PK plasma concentrations were summarised for the PK population by descriptive statistics.
Measured: Week 12 (pre-dose and 1 hour post-dose), week 24 and week 24/End of treatment
Descriptive Summary (Geometric Mean [95% CI]) of BGS649 Semen PK Concentration Values at 24 Weeks.
Semen PK sampling for BGS649 was performed at Visit 8 (End of Treatment). BGS649 PK semen concentrations were summarised for the PK population by descriptive statistics.
Measured: Week 24 and week 24/End of treatment

Timeline

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

12 May 201619 May 2018

First posted6 Apr 2016 (estimated)
Study start12 May 2016
Primary completion15 Feb 2018
Study completion19 May 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.
Publications (1)Papers the sponsor has linked to this study.
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: 271 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02730169
Sponsor's protocol ID: MBGS205
Status last verified: Aug 2022
First submitted: 17 Mar 2016
Last updated: 14 Sep 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No

Publications

Jones TH, Dobs AS, Randeva H, Moore W, Parkin JM. Leflutrozole in male obesity-associated hypogonadotropic hypogonadism: Ph 2b double-blind randomised controlled trial. Eur J Endocrinol. 2023 Sep 1;189(3):297-308. doi: 10.1093/ejendo/lvad099.
PubMed 37579053

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?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 14 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT02730169
Acronym / sponsor ID: MBGS205
Conditions: Hypogonadotropic Hypogonadism
Keywords: Hypogonadotropic, hypogonadism, testosterone
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 271 participants (actual)
Lead sponsor: Mereo BioPharmaIndustry (pharma, biotech, devices)
Study start: 12 May 2016 (actual)
Primary completion: 15 Feb 2018 (actual)
Study completion: 19 May 2018 (actual)
First posted: 6 Apr 2016 (estimated)
Results: Posted 25 Nov 2020

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
BGS649 0.1 mg	Experimental	Drug: BGS649BGS649 0.1 mg weekly (1 BGS649 0.1 mg capsule and 2 indistinguishable placebo capsules)
BGS649 0.3 mg	Experimental	Drug: BGS649BGS649 0.3 mg weekly (3 BGS649 0.1 mg capsules)
BGS649 1.0 mg	Experimental	Drug: BGS649BGS649 1.0 mg weekly (1 BGS649 1.0 mg capsule and 2 indistinguishable placebo capsules)
Placebo	Placebo comparator	Drug: PlaceboPlacebo weekly (3 indistinguishable placebo capsules)

Who may qualify

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

Key inclusion criteria (6 listed)

Adult male subject aged 18 to 65 years inclusive
BMI > 30 kg/m2 and < 50 kg/m2
Serum total testosterone concentration below the normal range
LH levels below the upper limit of normal
Oestradiol levels within or above the normal range of approved assay

Key exclusion criteria (3 listed)

Evidence of clinically significant endocrinopathy at screening that may interfere with the study assessments
Other types of hypogonadotropic hypogonadism or primary hypogonadism
Any other pituitary or hypothalamic disease

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
BGS649Capsules were taken weekly for a maximum of 24 weeks	Drug	BGS649 0.1 mg, BGS649 0.3 mg, BGS649 1.0 mg
PlaceboCapsules were taken weekly for a maximum of 24 weeks	Drug	Placebo

Primary outcome

Percentage of Patients With Normalised Testosterone After 24 Weeks of Study Treatment
Time frame: 24 weeks of treatment
Percentage of patients with normalised testosterone i.e. testosterone in the range 300-1000ng/dL after 24 weeks of study treatment. The primary objective was considered met, if greater than or equal to 75% of the participants in any arm normalised.

7 secondary outcomes

The Proportion of Subjects That Have Normalization of Total Testosterone Serum Concentrations From Baseline to Week 24
Time frame: Baseline, Day 8, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks and 24 weeks
Proportion of Subjects That Overshoot Testosterone (Total Testosterone Above 1000 ng/dL [35 Nmol/L]) From Baseline to Week 24
Time frame: Baseline, Day 8, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks and 24 weeks
Normalization of Total Testosterone Serum Concentrations in ≥ 90% Subjects After 24 Weeks of Treatment.
Time frame: 24 weeks of treatment
Mean (SD) Change From Baseline in Luteinizing Hormone (LH) to Week 24.
Time frame: Day 8, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks and 24 weeks
Mean (SD) Change From Baseline in Follicle Stimulating Hormone (FSH) to Week 24.
Time frame: Day 8, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks and 24 weeks
Descriptive Summary (Geometric Mean [95% CI]) of BGS649 Plasma PK Concentration Values to 24 Weeks.
Time frame: Week 12 (pre-dose and 1 hour post-dose), week 24 and week 24/End of treatment
Descriptive Summary (Geometric Mean [95% CI]) of BGS649 Semen PK Concentration Values at 24 Weeks.
Time frame: Week 24 and week 24/End of treatment

Results and safety

Results posted to the registry on 25 Nov 2020, 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	67	53
BGS649 0.3 mg	66	45
BGS649 1.0 mg	67	50
Placebo	71	55

Primary outcome: Percentage of Patients With Normalised Testosterone After 24 Weeks of Study Treatment

Time frame: 24 weeks of treatment. Count of participants. Unit: Participants

Measure	BGS649 0.1 mg n = 67	BGS649 0.3 mg n = 65	BGS649 1.0 mg n = 67	Placebo n = 71
Value	59	62	63	7

Population analysed: ITT Population

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: After randomisation and up to 90 days after the last administration of study drug.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
BGS649 0.1 mg	2 of 67 (3%)	37 of 67 (55.2%)	0 of 67
BGS649 0.3 mg	2 of 66 (3%)	39 of 66 (59.1%)	0 of 66
BGS649 1.0 mg	5 of 67 (7.5%)	47 of 67 (70.1%)	0 of 67
Placebo	5 of 71 (7%)	41 of 71 (57.7%)	0 of 71

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 37579053Jones TH, Dobs AS, Randeva H, Moore W, Parkin JM. Leflutrozole in male obesity-associated hypogonadotropic hypogonadism: Ph 2b double-blind randomised controlled trial. Eur J Endocrinol. 2023 Sep 1;189(3):297-308. doi: 10.1093/ejendo/lvad099.
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.

Hugh Jones principal investigator

Barnsley Hospital NHS Foundation Trust

63 sites in 4 countries: 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 63 sites in 4 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 6 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: finished, as of the sponsor's last update on 14 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 63 sites in United States, United Kingdom, Italy, Spain. 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 25 Nov 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 With Normalised Testosterone After 24 Weeks of Study Treatment (time frame: 24 weeks of treatment). 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 NCT02730169, which also lists 1 linked publication.

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 14 Sep 2022.