Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Bremelanotide · 6 trials · 5 indications
As measured by change from baseline to end-of-study in the desire domain from the FSFI (Question Q1 and Q2), 28-day recall, co-primary endpoint - FSFI desire domain This score is on a scale ranging from 1.2 to 6. A higher score on this scale represent an increase in sexual desire and is a better outcome.
As measured by the change from baseline to End-of-Study of the Core Study in the bothered by low desire item from the FSDS-DAO (item 13). Responses range from 0 (never) to 4 (always). Lower scores on this scale represent an increase in sexual desire and indicate a better outcome. Higher scores indicate a worse outcome.
Percent change in patient weight from baseline (Visit 2/Day 1) to Visit 10 (Day 57) for the BMT/tirzepatide combination group compared to placebo
Proportion of subjects with Type II diabetic nephropathy who achieve a 50% reduction in their urine protein Cr (UP/Cr) ratio after six months of combined therapy (RAAS inhibition therapy plus BMT). Inhibition therapy to reduce urinary protein and maintain podocyte density and functions in subjects with Type II diabetic nephropathy after six months.
Proportion of subjects with Type II diabetic nephropathy who achieve a 50% reduction in their urine protein Cr (UP/Cr) ratio after six months of combined therapy (RAAS inhibition therapy plus BMT) to determine the incidence of adverse events, related adverse events, adverse events of special interest, serious adverse events and BMT discontinuation.
The primary efficacy endpoint is change from baseline to end of study in the number of satisfying sexual events (SSEs), computed as the number of events during the last 4 weeks of treatment with FSEP-R Q10 = "Yes" minus the number of baseline events with FSEP-R Q10 = "Yes." Efficacy analyses were done with the MITT population which consisted of all randomized subjects who took at least 1 dose of double-blind treatment after the 2 in-clinic doses of double-blind medication and who had at least 1 follow-up visit (Visit 10 or later) to ensure that FSEP-R data were reviewed and confirmed by the investigative site.
| Arm | Type | Description |
|---|---|---|
| Bremelanotide (BMT/BMT) | EXPERIMENTAL | (Main Study) Subjects will self-administer a fixed dose (1.75 mg) of bremelanotide (BMT) subcutaneously (SC) via auto-injector on an as needed basis with no more than 1 dose taken every 24 hours for 24 weeks (OLE Study) Subjects will self-administer a fixed dose (1.75 mg) of bremelanotide (BMT) subcutaneously (SC) via auto-injector on an as needed basis with no more than 1 dose taken every 24 hours for 52 weeks |
| Placebo (PBO/BMT) | PLACEBO_COMPARATOR | (Main Study) PBO administered SC on an as-desired basis for 24 weeks (OLE Study) subjects will self-administer a fixed dose (1.75 mg) of bremelanotide (BMT) subcutaneously (SC) via auto-injector on an as needed basis with no more than 1 dose taken every 24 hours for 52 weeks |
| tirzepatide and bremelanotide Combination Therapy | ACTIVE_COMPARATOR | - |
| tirzepatide Monotherapy | PLACEBO_COMPARATOR | N=1 |
| bremelanotide Monotherapy | PLACEBO_COMPARATOR | - |
| Placebo | NO_INTERVENTION | - |
| Subcutaneous Bremelanotide | EXPERIMENTAL | BMT sterile aqueous solution for injection provided as a prefilled syringe, administered by subcutaneous (SQ) injection into the abdomen. |
| bremelanotide arm 1 | EXPERIMENTAL | Low dose: Investigational product: Bremelanotide aqueous solution for subcutaneous (SC) injection, provided as pre-filled syringes containing 0.75 mg in 0.3 mL volume. Subjects will self-administer bremelanotide by SC injection into the anterior thigh or abdomen. |
| bremelanotide arm 2 | EXPERIMENTAL | Middle dose: Investigational product: Bremelanotide aqueous solution for subcutaneous (SC) injection, provided as pre-filled syringes containing 1.25 mg in 0.3 mL volume. Subjects will self-administer bremelanotide by SC injection into the anterior thigh or abdomen. |
| bremelanotide arm 3 | EXPERIMENTAL | High dose: Investigational product: Bremelanotide aqueous solution for subcutaneous (SC) injection, provided as pre-filled syringes containing 1.75 mg in 0.3 mL volume. Subjects will self-administer bremelanotide by SC injection into the anterior thigh or abdomen. |
| Name | Type | Description |
|---|---|---|
| Bremelanotide | DRUG | A melanocortin agonist and synthetic peptide analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone) |
| Placebo | DRUG | Placebo |
| tirzepatide | DRUG | tirzepatide (GLP-1/GIP) will be provided in its commercial form for SC injection. |
| RAAS inhibition therapy | DRUG | RAS-acting agents are medicines acting on a hormone system that helps to control blood pressure and the amount of fluid in the body. |
Main Inclusion Criteria: * Has met diagnostic criteria for HSDD for at least 6 months * Is willing and able to understand and comply with all study requirements * Has a normal pelvic examination at screening Main Exclusion Criteria: * Subjects should be generally healthy premenopausal females wit...