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

NCT02730169 | Completed Phase 2 Results DMC

• 1 other identifier: MBGS205
• Study Type: interventional
• Target: 271
• Locations: 4 countries
• Sites: 63

Brief Summary

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

Keywords

Hypogonadotropic; hypogonadism; testosterone

Outcome Measures

Primary Outcomes (1)

• 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.

  24 weeks of treatment

Secondary Outcomes (7)

• The Proportion of Subjects That Have Normalization of Total Testosterone Serum Concentrations From Baseline to Week 24

  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

  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.

  24 weeks of treatment

• Mean (SD) Change From Baseline in Luteinizing Hormone (LH) to Week 24.

  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.

  Day 8, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks and 24 weeks

Other Outcomes (6)

• Mean (SD) Change From Baseline in Prostate Specific Antigen (PSA) to Week 24.

  Baseline, Day 8, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks and 24 weeks

• Mean (SD) Change From Baseline in Haematocrit to Week 24.

  Day 8, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks and 24 weeks

• Mean (SD) Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan T-score by Location at Week 24.

  Screening to Week 24

Study Arms (4)

BGS649 0.1 mg

EXPERIMENTAL

BGS649 0.1 mg weekly (1 BGS649 0.1 mg capsule and 2 indistinguishable placebo capsules)

Drug: BGS649

BGS649 0.3 mg

EXPERIMENTAL

BGS649 0.3 mg weekly (3 BGS649 0.1 mg capsules)

Drug: BGS649

BGS649 1.0 mg

EXPERIMENTAL

BGS649 1.0 mg weekly (1 BGS649 1.0 mg capsule and 2 indistinguishable placebo capsules)

Drug: BGS649

Placebo

PLACEBO COMPARATOR

Placebo weekly (3 indistinguishable placebo capsules)

Drug: Placebo

Interventions

BGS649 DRUG

Capsules were taken weekly for a maximum of 24 weeks

BGS649 0.1 mg; BGS649 0.3 mg; BGS649 1.0 mg

Placebo DRUG

Capsules were taken weekly for a maximum of 24 weeks

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mereo BioPharma: lead

Study Sites (63)

Mereo Research Site

Birmingham, Alabama, United States

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Mobile, Alabama, United States

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Chandler, Arizona, United States

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Phoenix, Arizona, United States

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Scottsdale, Arizona, United States

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Anaheim, California, United States

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Carlsbad, California, United States

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Greenbrae, California, United States

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Lincoln, California, United States

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Los Angeles, California, United States

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San Diego, California, United States

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Bradenton, Florida, United States

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DeLand, Florida, United States

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Fort Myers, Florida, United States

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Hialeah, Florida, United States

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Homestead, Florida, United States

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St. Petersburg, Florida, United States

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Meridian, Idaho, United States

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Gurnee, Illinois, United States

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Evansville, Indiana, United States

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New Orleans, Louisiana, United States

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Baltimore, Maryland, United States

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Elkridge, Maryland, United States

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St Louis, Missouri, United States

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Omaha, Nebraska, United States

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Henderson, Nevada, United States

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Las Vegas, Nevada, United States

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Albany, New York, United States

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Garden City, New York, United States

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Great Neck, New York, United States

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New York, New York, United States

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Rochester, New York, United States

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Charlotte, North Carolina, United States

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Raleigh, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Middleburg Heights, Ohio, United States

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Mt. Pleasant, South Carolina, United States

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Nashville, Tennessee, United States

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Smyrna, Tennessee, United States

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Spring Hill, Tennessee, United States

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Dallas, Texas, United States

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Fort Worth, Texas, United States

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Pearland, Texas, United States

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San Antonio, Texas, United States

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Murray, Utah, United States

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West Jordan, Utah, United States

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Norfolk, Virginia, United States

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Kenosha, Wisconsin, United States

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Ancona, Italy

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Parma, Italy

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Roma, Italy

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Siena, Italy

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Coslada, Spain

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Girona, Spain

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Madrid, Spain

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Majadahonda, Spain

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Barnsley, United Kingdom

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Coventry, United Kingdom

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Dundee, United Kingdom

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Edinburgh, United Kingdom

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Hull, United Kingdom

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Manchester, United Kingdom

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Newcastle, United Kingdom

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Related Publications (1)

• 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.

  PMID: 37579053 DERIVED

MeSH Terms

Conditions

Hypogonadism

Condition Hierarchy (Ancestors)

Gonadal Disorders; Endocrine System Diseases

Results Point of Contact

• Title: Jackie Parkin
• Organization: Mereo BioPharma Group

enquiries@mereobiopharma.com

+44 (0) 333 023 7300

Study Officials

• Hugh Jones

  Barnsley Hospital NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2016
• First Posted: April 6, 2016
• Study Start: May 12, 2016
• Primary Completion: February 15, 2018
• Study Completion: May 19, 2018
• Last Updated: September 14, 2022
• Results First Posted: November 25, 2020

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (7); IT (4); ES (4); US (48)