A trial to investigate efficacy and safety of vipoglanstat in women with endometriosis

• Research type

  Research Study

• Full title

  A Phase 2, randomized, double-blind, placebo-controlled trial to investigate the efficacy and safety of 2 doses of vipoglanstat in patients with moderate to severe endometriosis-related pain – the NOVA trial

• IRAS ID

  1012480

• Contact name

  Helen Watson

• Contact email

  iconregulatoryaffairs@iconplc.com

• Sponsor organisation

  Gesynta Pharma AB

• Research summary

  The Non-hormonal Option: Vipoglanstat Assessment trial (NOVA trial), is looking to find out how well 2 different doses of the study drug, vipoglanstat, work to reduce pain in people with moderate to severe endometriosis a chronic inflammatory disorder affecting around 190 million women and girls of reproductive age. Endometriosis often causes chronic non-menstrual pelvic pain. There is an unmet need for non-hormonal, non-opioid anti-inflammatory medicines to reduce chronic pain in people with endometriosis. In addition to the effects on pain the study will also monitor the safety of vipoglanstat.
  The study will include around 190 participants with endometriosis, ages 18 to 45 across the EU and UK. All participants will need to stop taking current treatment for endometriosis including hormonal contraception for the length of the study.

  The total time a participant is expected to be in the study is 6 to 10 months, depending on the time needed to remove hormonal treatments from their body and the participant's menstrual cycle length.
  Participants will attend 8 site visits and will be expected to complete a daily electronic diary regarding their symptoms and pain. Between visits there will be phone calls from site staff to check in and encourage participants to complete the diary.
  At Visit 3 participants will be randomly assigned to take one of 2 doses of vipoglanstat or placebo, neither participants nor their doctors will know which assignment they have been given. The placebo and vipoglanstat capsules will look identical, while placebo contains no active drug. The capsules are taken orally daily until Visit 7 (4 menstrual cycles or maximum 119 days). Participants will have a final site visit 30 days after taking the last dose of study drug.

• REC name

  East Midlands - Leicester Central Research Ethics Committee

• REC reference

  25/EM/0172

• Date of REC Opinion

  22 Aug 2025

• REC opinion

  Further Information Favourable Opinion