OG-6219 for Endometriosis

(ELENA Trial)

No longer recruiting at 120 trial locations

Overseen By Sarah Artman

Age: 18 - 65

Sex: Female

Trial Phase: Phase 2

Sponsor: Organon and Co

Must not be taking: CYP3A4 inhibitors, inducers

Disqualifiers: Hysterectomy, Chronic pain, HPV, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 16 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new drug, OG-6219, to determine if it can relieve pain for women with moderate to severe endometriosis. The study aims to assess the effectiveness and safety of three different doses of this drug compared to a placebo (a harmless pill with no active drug). Women who have undergone surgery to diagnose endometriosis and experience regular menstrual cycles with significant pelvic pain might be suitable for this trial. Participants will join one of four groups receiving different doses of the drug or a placebo. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial does not specify if you must stop taking your current medications, but you cannot use any medication that affects the CYP3A4 enzyme within 30 days or 10 half-lives before starting the trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that OG-6219 has promising safety results from earlier studies. One study found the treatment safe and well-tolerated by both pre- and postmenopausal women. Importantly, it did not cause side effects related to low estrogen levels, a concern with some treatments. Although OG-6219 did not significantly reduce endometriosis pain compared to a placebo in some studies, it still maintains a strong safety profile. Participants experienced few to no serious side effects, making it a potentially safe option for further trials. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for endometriosis?

Unlike the standard treatments for endometriosis, which often include hormonal therapies and pain management medications, OG-6219 is an experimental drug designed to target the condition more directly. Researchers are excited about OG-6219 because it offers a novel approach by potentially modulating specific pathways involved in inflammation and pain associated with endometriosis. This targeted action could mean improved effectiveness and fewer side effects compared to traditional hormonal treatments. Additionally, OG-6219 is administered in multiple doses, potentially allowing for tailored treatment depending on patient response, which is not a common feature of current therapies.

What evidence suggests that OG-6219 could be an effective treatment for endometriosis?

Research has shown that OG-6219 has not been effective in reducing moderate-to-severe pelvic pain caused by endometriosis compared to a placebo. Previous studies found no significant difference in pain relief between OG-6219 and a placebo for endometriosis patients. This suggests that OG-6219 may not work as hoped for this condition. The current trial is exploring whether different doses of OG-6219 might help, but current evidence does not support its effectiveness. ^{1 2 3 6 7}

Who Is on the Research Team?

Clinical Lead Late-Stage Clinical Development

Principal Investigator

Organon and Co

Are You a Good Fit for This Trial?

This trial is for pre-menopausal women aged 18 to 49 with surgically diagnosed endometriosis and moderate to severe pain related to it. Participants must be able to follow study procedures and use two non-hormonal contraception methods. Those with a history of certain blood disorders or chronic pain not caused by endometriosis are excluded.

Inclusion Criteria

My endometriosis was confirmed through surgery.

I am a woman aged 18-49 and have not gone through menopause.

Able and willing to adhere to study procedures, including agree to use 2 forms of non-hormonal contraception throughout the study

Exclusion Criteria

I have long-term pelvic or body pain not due to endometriosis, needing regular pain treatment.

I have had unexplained vaginal bleeding in the last 6 months.

My family has a history of blood conditions that could lead to methemoglobinemia.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive one of three dose levels of OG-6219 or placebo for endometriosis-related pain

16 weeks

Regular visits throughout treatment

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 Safety Follow-up visit

What Are the Treatments Tested in This Trial?

Interventions

• OG-6219
• Placebo

Trial Overview The trial is testing the effectiveness, safety, and tolerability of three different doses of OG-6219 compared with a placebo in managing endometriosis-related pain. This global Phase 2 study involves pre-menopausal women who will receive either the drug or placebo twice daily (BID).

How Is the Trial Designed?

Group I: Group C: OG-6219 Dose 3 Experimental Treatment 1 Intervention

Group C: OG-6219 Dose 3 BID

Group II: Group B: OG-6219 Dose 2 Experimental Treatment 1 Intervention

Group B: OG-6219 Dose 2 BID

Group III: Group A: OG-6219 Dose 1 Experimental Treatment 1 Intervention

Group A: OG-6219 Dose 1 BID

Group IV: Group D: Placebo Placebo Group 1 Intervention

Group D: Placebo BID

Who Is Running the Clinical Trial?

Organon and Co

Lead Sponsor

Trials

492

Recruited

1,733,000+

Juan Camilo Arjona Ferreira

Organon and Co

Chief Medical Officer since 2023

MD

Kevin Ali

Organon and Co

Chief Executive Officer since 2021

MBA from Santa Clara University, BA from the University of California, Berkeley

Iqvia Pty Ltd

Industry Sponsor

Trials

120

Recruited

177,000+

Ari Bousbib

Iqvia Pty Ltd

Chief Executive Officer since 2016

MBA from Columbia University, Master of Science in Mathematics and Mechanical Engineering from Ecole Superieure des Travaux Publics, Paris

Jeffrey Spaeder

Iqvia Pty Ltd

Chief Medical Officer

MD

Published Research Related to This Trial

Depot medroxyprogesterone acetate (DMPA-SC 104) is as effective as leuprolide in reducing endometriosis-associated pain over an 18-month period, with significant improvements in multiple pain categories.

DMPA-SC 104 causes significantly less decline in bone mineral density compared to leuprolide, and BMD levels return to pre-treatment levels 12 months after stopping DMPA-SC 104, indicating a safer profile for bone health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Subcutaneous depot medroxyprogesterone acetate versus leuprolide acetate in the treatment of endometriosis-associated pain. Crosignani, PG., Luciano, A., Ray, A., et al.[2022]

Citations

1. organon.com organon.com/news/organon-provides-update-on-phase-2-elena-proof-of-concept-study-evaluating-og-6219-in-patients-with-endometriosis-related-pain/

Organon Provides Update on Phase 2 ELENA Proof-of- ... In the study, OG-6219 did not demonstrate improvement in moderate-to-severe endometriosis-related overall pelvic pain compared to placebo. Based ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05560646

A Study to Investigate Efficacy and Safety of OG-6219 BID ... The purpose of this global Phase 2 study is to determine the efficacy, safety, and tolerability of 3 dose levels of OG-6219 in pre-menopausal women between 18 ...

3. clinicaltrials.eu clinicaltrials.eu/trial/study-on-the-effectiveness-and-safety-of-og-6219-and-naproxen-sodium-for-women-aged-18-49-with-moderate-to-severe-endometriosis-pain/

Study on the Effectiveness and Safety of OG-6219 and ... This study investigates the effectiveness and safety of OG-6219 in reducing moderate to severe endometriosis pain in women aged 18 to 49, ...

4. clinicaltrialsarena.com clinicaltrialsarena.com/news/organon-endometriosis-drug-discontinued-phase-ii-flop/

Organon discontinues endometriosis drug after Phase II flunk In the study, OG-6219 failed to demonstrate improvement in moderate-to-severe endometriosis-related overall pelvic pain compared to placebo, the ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10175629/

Targeting the formation of estrogens for treatment of hormone ... Endometriosis, NCT05560646, A Study to Investigate Efficacy and Safety of OG-6219 BID in 3 Dose Levels Compared With Placebo in Participants ...

6. europeanpharmaceuticalreview.com europeanpharmaceuticalreview.com/news/144781/for-6219-shows-promise-in-phase-i-endometriosis-trial/

FOR-6219 shows promise in Phase I endometriosis trial FOR-6219 was found to be safe and well tolerated by healthy pre- and postmenopausal women and did not induce systemic oestrogen deficiency-related side effects.

7. delta.larvol.com delta.larvol.com/Products/?ProductId=cade04f3-429c-4f3c-b577-c1d7e3d0a466

OG-6219 / Organon - Endometriosis OG-6219 is a novel reversible inhibitor of HSD17B1 that may allow an alternative strategy for controlling endometriosis.