In short
Clinical trials are investigating VIPOGLANSTAT in women with endometriosis. The main goal is to see whether it can help reduce endometriosis-related pain and whether it is safe and effective in this patient group.
Key points
- VIPOGLANSTAT is being studied in a Phase 2 trial for women with endometriosis. The trial focuses on endometriosis-related pain and aims to see whether the treatment can reduce pain in a meaningful way. The study plans to enroll 300 participants and is currently authorised. The main endpoint looks at improvement in worst pain scores during non-menstrual days without more opioid rescue medication. This trial is an interventional study, meaning participants receive a study treatment and outcomes are measured over time.
Trial overview
This clinical trial is a Phase 2 study of VIPOGLANSTAT in women with endometriosis. It is an interventional study, which means researchers are giving study treatment and then measuring the results.
The trial is designed to investigate the efficacy and safety of VIPOGLANSTAT for endometriosis-related pain. The brief summary says the study aims to evaluate VIPOGLANSTAT on endometriosis-related NMPP.
Who is being studied
The target population is women with endometriosis and endometriosis-related pain. The trial data does not list more detailed eligibility rules, so the main group to know about is women affected by this condition.
Endometriosis-related pain is the main condition being studied in this trial. The study focuses on people who have pain outside menstrual days as part of their symptoms.
What the trial measures
The main result, called the primary outcome, is the proportion of participants who have at least a 2.0-point or at least 30% reduction in their mean worst pain score, without increased opioid rescue medication use, during non-menstrual days from baseline to month 4.
In simple terms, the researchers want to know how many participants get a clear drop in their worst pain and do not need more extra pain medicine. The pain scale used is the NMPP NRS score, which is a number-based pain rating scale.
The trial also looks at pain during non-menstrual days, which are days when the participant is not having a period. This helps the researchers understand whether the treatment may improve pain beyond menstrual symptoms alone.
Study design and treatment groups
The trial includes VIPOGLANSTAT capsules and a placebo that looks the same. A placebo is an inactive look-alike capsule used for comparison so researchers can judge whether changes are due to the study treatment.
The source data also mentions GS-248 and a placebo formulation for GS-248, but it does not provide further details about the role of these groups. Because the source is limited, the clearest confirmed focus is the comparison of VIPOGLANSTAT with matching placebo capsules.
Trial status and size
The trial status is Authorised, meaning it has been approved to proceed. The planned enrollment is 300 participants.
This size suggests the study is designed to collect enough information to better understand whether VIPOGLANSTAT may help with endometriosis-related pain in this patient group. The trial is focused on a patient-centered outcome: meaningful pain improvement without more rescue opioid use.