Safety and Efficacy of BGS649 in Obese, Hypogonadotropic Hypogonadal Men (OHH)
This study has been completed.
Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01200862
First received: September 10, 2010
Last updated: March 14, 2013
Last verified: March 2013
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Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
Obese Hypogonadotropic Hypogonadism |
Drug: Investigational new drug company code: BGS649 Drug: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Novartis:
Primary Outcome Measures:
- Normalization of testosterone levels [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Determine effect of BGS649 on insulin sensitivity [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Safety and tolerability of BGS649 in obese men [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
- Assess the pharmacodynamic effect of BGS649 on glucose, insulin and lipid metabolism, and body composition [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 239 |
| Study Start Date: | August 2010 |
| Study Completion Date: | August 2012 |
| Primary Completion Date: | August 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: BGS649 | Drug: Investigational new drug company code: BGS649 |
| Placebo Comparator: Placebo to BGS649 | Drug: Placebo |
Eligibility| Ages Eligible for Study: | 30 Years to 65 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
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
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.
Exclusion Criteria:
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01200862
Locations
| United States, Arizona | |
| Novartis Investigative Site | |
| Tucson, Arizona, United States, 85712 | |
| United States, California | |
| Novartis Investigative Site | |
| San Diego, California, United States, 92120 | |
| United States, Florida | |
| Novartis Investigative Site | |
| Miramar, Florida, United States, 33025 | |
| United States, Utah | |
| Novartis Investigative Site | |
| West Valley City, Utah, United States, 84120 | |
| Canada, Quebec | |
| Novartis Investigative Site | |
| Montreal, Quebec, Canada, H3X 2H9 | |
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
| Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
More Information
No publications provided
| Responsible Party: | Novartis ( Novartis Pharmaceuticals ) |
| ClinicalTrials.gov Identifier: | NCT01200862 History of Changes |
| Other Study ID Numbers: | CBGS649A2204 |
| Study First Received: | September 10, 2010 |
| Last Updated: | March 14, 2013 |
| Health Authority: | United States: Food and Drug Administration Canada: Health Canada |
Keywords provided by Novartis:
|
Obese obesity hypogonadism hypogonadotropic |
hyperestrogenemic testosterone hypogonadal |
Additional relevant MeSH terms:
|
Hypogonadism Obesity Gonadal Disorders Endocrine System Diseases Overnutrition |
Nutrition Disorders Overweight Body Weight Signs and Symptoms |
ClinicalTrials.gov processed this record on June 18, 2013