RecruitingPhase 2

Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of EVER001 in Participants With Selected Proteinuric Glomerular Diseases

China45 participantsStarted 2026-05-15

Plain-language summary

This is a Phase 1b/2, open-label, multi-center study evaluating the therapeutic potential and safety of the investigational drug EVER001 in adults with FSGS, MCD, or IgAN. EVER001 acts on multiple immune pathways without directly affecting T cells or depleting B cells (both are lymphocytes). The study will be conducted at \~30 centers in China, enrolling 45 participants aged 18-75 years (15 per indication). The IMP is a 100 mg oral capsule, dosed at 200 mg twice daily (2 capsules per dose, 4 daily) for 52 weeks.

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Primary FSGS or MCD/IgAN confirmed by renal biopsy * eGFR ≥ 45 mL/min/1.73 m² * For participants with FSGS or MCD: must have a 24-hour urine protein-to-creatinine ratio (UPCR) \> 3.5 g/g and serum albumin \< 30 g/L during the screening period * For participants in the IgAN group: 24-hour UPCR ≥ 0.8 g/g; ARB or ACEI stable for ≥ 12 weeks prior to Day 1 * Patients with FSGS or MCD who have not been treated with immunosuppressants or are sensitive to prior immunosuppressant treatment Exclusion Criteria: * Hereditary or secondary FSGS/MCD; collapsing FSGS * BMI ≥ 35 kg/m² in participants with FSGS/MCD * Evidence of diabetes mellitus or a history of diabetes mellitus * Acute or chronic infection requiring treatment * Patients infected with HIV, hepatitis C, syphilis, or hepatitis B * Patients with current or prior inadequately treated active tuberculosis (TB), latent TB, or evidence of current household contact with active TB * At risk of bleeding * Baseline 24-hour UPCR \> 3 g/g and serum albumin \< 30 g/L in participants with IgAN

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Percentage change from baseline in 24-hour urine protein-to-creatinine ratio (UPCR)

Timeframe: Week24

Treatment-emergent adverse events (TEAEs)

Timeframe: Throughout the study period, up to Week 56

Adverse events of special interest (AESIs)

Timeframe: Throughout the study period, up to Week 56

Systolic blood pressure change from baseline

Timeframe: Throughout the study period, up to Week 56

Body weight change from baseline

Timeframe: Throughout the study period, up to Week 56

Change from baseline in clinical laboratory safety parameters

Timeframe: Throughout the study period, up to Week 56

Physical examination findings

Timeframe: Throughout the study period, up to Week 56

Trial details

NCT IDNCT07614477

SponsorEverest Medicines (China) Co.,Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2028-12-31

Contact for this trial

Fei Liao

+8621- 8012 5712 fei.liao@everestmedicines.com

View on ClinicalTrials.gov More Minimal Change Disease (MCD) trials

Plain-language summary

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Percentage change from baseline in 24-hour urine protein-to-creatinine ratio (UPCR)

Timeframe: Week24

Treatment-emergent adverse events (TEAEs)

Timeframe: Throughout the study period, up to Week 56

Adverse events of special interest (AESIs)

Timeframe: Throughout the study period, up to Week 56

Systolic blood pressure change from baseline

Timeframe: Throughout the study period, up to Week 56

Body weight change from baseline

Timeframe: Throughout the study period, up to Week 56

Change from baseline in clinical laboratory safety parameters

Timeframe: Throughout the study period, up to Week 56

Physical examination findings

Timeframe: Throughout the study period, up to Week 56