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GS-248

Clinical trials are investigating GS-248 in women with endometriosis. These studies aim to evaluate treatment benefit and safety, especially for endometriosis-related pain. The available trial data describes a Phase 2 study comparing GS-248 with placebo in adult women.

Table of Contents

Trial overview

The available clinical trial for GS-248 is an interventional study, which means researchers give a study treatment and then measure the results.[1] It is a Phase 2 trial, so it is designed to look more closely at whether the treatment may help and to continue checking safety.[1] The study is authorised and plans to enroll 300 participants.[1]

This trial is being done in women with endometriosis and pain related to that condition.[1] The brief summary says the study aims to evaluate the efficacy of vipoglanstat on endometriosis-related NMPP.[1]

Who can join the study

The trial data says the target population is women with endometriosis.[1] The condition being studied is endometriosis related pain, so the study is focused on people who have pain linked to endometriosis.[1]

NMPP in the trial summary refers to non-menstrual pelvic pain, which means pelvic pain that happens outside the menstrual period.[1] The primary outcome also focuses on non-menstrual days, which helps show whether pain changes when the person is not having a period.[1]

What is being measured

The main endpoint is the proportion of participants who have at least a 2.0-point or at least 30% reduction in the mean worst NMPP NRS score, without an increase in opioid rescue medication use.[1] In simple terms, the study wants to know how many people get a meaningful drop in their worst pain score while not needing more extra pain medicine.[1]

The pain score is measured during non-menstrual days from baseline to the fourth month of treatment.[1] Baseline means the starting point before treatment begins, so the researchers can compare later results with the first measurements.[1]

Study design and treatment groups

The interventions listed in the trial include GS-248, vipoglanstat, and a placebo formulation for GS-248.[1] A placebo is an inactive capsule that looks the same as the real treatment, which helps make the comparison fair.[1]

The trial description says both vipoglanstat capsules and placebo are identical capsules.[1] This suggests the study is designed so participants and researchers may not be able to tell which capsule is being taken just by looking at it.[1]

GS-248 is given orally, which means it is taken by mouth.[1] The source data does not provide more detail about the treatment schedule, so the article focuses only on the information listed in the trial record.[1]

What the trial results may show

If many participants meet the main pain goal, the study may suggest that GS-248 could help reduce endometriosis-related pain in this group.[1] If the pain score does not improve enough, or if more rescue medicine is needed, that would make the treatment look less helpful for this outcome.[1]

Because this is a Phase 2 study, the results are still early and are mainly meant to guide later research.[1] The trial data provided here does not include final results, so the article only describes what the study is designed to test.[1]

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

FAQ

  • What is being studied in GS-248 clinical trials? The trial is studying GS-248 in women with endometriosis. It is looking at whether the treatment can reduce endometriosis-related pain and whether it is safe to use in the study setting.
  • Who can take part in the GS-248 trial? The available trial is for women with endometriosis. The study focuses on people with endometriosis-related pain, so participation is limited to that target group.
  • What phase is the GS-248 study? The trial is a Phase 2 study. Phase 2 trials usually look more closely at whether a treatment works and continue checking safety.
  • What condition is GS-248 being tested for? GS-248 is being tested for endometriosis-related pain. The study summary also mentions non-menstrual pelvic pain, which is pain that happens outside the menstrual period.
  • What result is the trial measuring? The main result is the number of participants who have a meaningful drop in worst pain scores without needing more opioid rescue medicine. This is checked during non-menstrual days from the start of treatment to month 4.

Ongoing Clinical Trials on GS-248

  • 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 linked to endometriosis. It may include pelvic pain and pain that gets worse during periods.
  • Phase 2: A mid-stage clinical trial. It usually studies whether a treatment may work and continues to monitor safety.
  • Interventional study: A study where researchers give a treatment or placebo and then measure the effects.
  • Placebo: An inactive study treatment that looks the same as the real treatment. It helps researchers compare results fairly.
  • Oral: Taken by mouth.
  • Efficacy: How well a treatment works for the condition being studied.
  • Safety: How well a treatment is tolerated and whether it causes unwanted effects in the study.
  • Primary outcome: The main result the researchers plan to measure in a trial.
  • Opioid rescue medication: Extra pain medicine used when study treatment does not control pain well enough.
  • Non-menstrual days: Days when a person is not having a menstrual period.
  • NRS pain score: A number rating scale for pain, usually from 0 to 10, where higher numbers mean worse pain.

References

  1. https://clinicaltrials.gov/study/2025-522452-16-00