Safety and Efficacy of BGS649 in Obese, Hypogonadotropic Hypogonadal Men

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• Hypogonadism 345

Keywords

• Obese
• obesity
• hypogonadism
• hypogonadotropic
• hyperestrogenemic
• testosterone
• hypogonadal

Hypogonadism

345 studies on the registry are indexed under Hypogonadism; 43 are open to participants now.

This study's enrollment of 29 is below the median of 56 across 260 interventional studies indexed under Hypogonadism.

Lead sponsor

Mereo BioPharma is the lead sponsor of 12 studies on the registry; none are open to participants now.

Study arms

• Experimental
  BGS649 (Part 1)

  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.

  Drug: Investigational new drug company code: BGS649

• Placebo comparator
  Placebo to BGS649 (Part 2)

  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).

  Drug: Placebo

• Experimental
  BGS649 (Part 2)

  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).

  Drug: Investigational new drug company code: BGS649

Interventions

• DrugInvestigational new drug company code: BGS649
• DrugPlacebo

Primary outcomes

1. 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

   Time frame: At Week 4 and 12

2. 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.

   Time frame: Baseline, Week 4 and Week 12

Secondary outcomes

1. 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.

   Time frame: 11 weeks

2. 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.

   Time frame: Week 1 to Week 11

3. 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.

   Time frame: Week 1 to Week 11

4. 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.

   Time frame: Week 1 to Week 11

Baseline characteristics

Individual participant data

Plan to share: No