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VIPOGLANSTAT

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.

Table of contents

Trial overview

This clinical trial is a Phase 2 study of VIPOGLANSTAT in women with endometriosis.[1] It is an interventional study, which means researchers are giving study treatment and then measuring the results.[1]

The trial is designed to investigate the efficacy and safety of VIPOGLANSTAT for endometriosis-related pain.[1] The brief summary says the study aims to evaluate VIPOGLANSTAT on endometriosis-related NMPP.[1]

Who is being studied

The target population is women with endometriosis and endometriosis-related pain.[1] The trial data does not list more detailed eligibility rules, so the main group to know about is women affected by this condition.[1]

Endometriosis-related pain is the main condition being studied in this trial.[1] The study focuses on people who have pain outside menstrual days as part of their symptoms.[1]

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.[1]

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.[1] The pain scale used is the NMPP NRS score, which is a number-based pain rating scale.[1]

The trial also looks at pain during non-menstrual days, which are days when the participant is not having a period.[1] This helps the researchers understand whether the treatment may improve pain beyond menstrual symptoms alone.[1]

Study design and treatment groups

The trial includes VIPOGLANSTAT capsules and a placebo that looks the same.[1] A placebo is an inactive look-alike capsule used for comparison so researchers can judge whether changes are due to the study treatment.[1]

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.[1] Because the source is limited, the clearest confirmed focus is the comparison of VIPOGLANSTAT with matching placebo capsules.[1]

Trial status and size

The trial status is Authorised, meaning it has been approved to proceed.[1] The planned enrollment is 300 participants.[1]

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.[1] The trial is focused on a patient-centered outcome: meaningful pain improvement without more rescue opioid use.[1]

Trial ID Phase Condition studied Status Enrollment
2025-522452-16-00 Phase 2 Endometriosis related pain Authorised 300

FAQ

  • What is VIPOGLANSTAT being studied for? It is being studied for endometriosis-related pain. The trial is looking at whether it can reduce pain symptoms in women with endometriosis.
  • Who can take part in the VIPOGLANSTAT trial? The study is for women with endometriosis. The trial data specifically mentions endometriosis-related pain as the condition being studied.
  • What phase is the VIPOGLANSTAT trial? The trial is in Phase 2. This means it is an early study that looks more closely at whether the treatment may work and how safe it is.
  • What outcome is the trial measuring? The main outcome is the number of participants who have a meaningful drop in their worst pain score during non-menstrual days. The study also checks that this happens without increased use of opioid rescue medication.
  • What is the status of the VIPOGLANSTAT trial? The trial status is Authorised. That means the study has been approved to move forward.

Ongoing Clinical Trials on VIPOGLANSTAT

  • A study testing vipoglanstat for women with moderate to severe endometriosis-related pain

    Recruiting

    2 1
    Investigated drugs:
    Bulgaria Czechia Hungary Italy Poland Romania

Glossary

  • Endometriosis: A condition where tissue similar to the lining of the uterus grows outside the uterus. It can cause pain and other symptoms.
  • Endometriosis-related pain: Pain caused by endometriosis. This is the main symptom being studied in the trial.
  • Phase 2: An early stage of clinical research that looks at whether a treatment may work and gathers more safety information.
  • Interventional study: A study where researchers give a treatment or intervention and then measure the results.
  • Placebo: A look-alike treatment with no active ingredient. It helps researchers compare results fairly.
  • Primary outcome: The main result the researchers plan to measure to see if the trial is successful.
  • NRS score: A number rating scale used to measure pain. Higher numbers usually mean worse pain.
  • Opioid rescue medication: Extra pain medicine used if needed during the study. The trial checks whether pain improves without needing more of this medicine.
  • Non-menstrual days: Days when a person is not having menstrual bleeding. The trial measures pain during these days.
  • Enrollment: The number of participants planned for the study.

References