Amyotrophic Lateral SclerosisPhase 1NCT06215755
A Study of VRG50635 in Participants With Amyotrophic Lateral Sclerosis (ALS)
A Phase 1 study testing VRG50635 in people with Amyotrophic Lateral Sclerosis, run by Verge Genomics at 7 sites in 4 countries.
Trial summary
The primary purpose of this study is to evaluate the safety and tolerability of VRG50635 in participants with ALS. Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Amyotrophic Lateral Sclerosis
- What is being tested?
- VRG50635
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 7 sitesin 4 countries
- Study dates
- 15 Jan 2024to 7 Jul 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provide written informed consent and be willing and able to comply with the requirements of the study protocol.
- Must be ≥ 18 and ≤ 75 years of age at the time of signing the informed consent form (ICF).
- Have a diagnosis of ALS according to the Gold Coast Diagnostic Criteria.
- Have either sporadic amyotrophic lateral sclerosis (sALS) or familial amyotrophic lateral sclerosis (fALS).
- Treatment Research Initiative to Cure ALS (TRICALS) risk profile > -6.00 and < -2.00.
- Have slow vital capacity (SVC) ≥ 60% of the predicted value.
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- Have a score of 3 or 4 on Item #3 (Swallowing) of the Harmonized ALS Functional Rating Scale-Revised (ALS-FRS-R). Participants with a score of 3 can be enrolled with the Sponsor's approval only if they are able to safely swallow capsules.
- Have a body weight ≥ 45 kg and body mass index (BMI) ≥ 18 kg/m2.
- Participants of childbearing potential are eligible to participate if they are not pregnant or breastfeeding and agree to use one highly effective method of contraception, if sexually active, for the duration of the study through 90 days after the last study drug administration. Participants must not donate eggs for the duration of study through 90 days after the last dose of study drug.
- Participants capable of producing sperm and their partners of childbearing potential must agree to use condoms and one highly effective method of contraception, respectively, for the duration of the study through 90 days after the last study drug administration. Participants must not donate sperm for the duration of study through 90 days after the last dose of study drug.
- Be able and willing to undergo measurement of at-home mobility using contactless sensors connected to the internet.
- Be able and willing to have clinic or at-home visits during the study.
Who cannot join
- Have active psychiatric disease, substance abuse, neuromuscular weakness other than ALS, or any other medical condition that, in the opinion of the Investigator, might confound the results of the study or interfere with the intake or absorption of the study drug or participation for the full duration of the study.
- Have a history of unstable or severe cardiac, pulmonary, neurological, oncological, hepatic, or renal disease or another medically significant illness other than ALS precluding their safe participation in this study.
- Have a history of substance use disorder or illicit drug use in the last year (medically prescribed or over-the-counter cannabis use is allowed, if legal in the country).
- Have a history of serious infection (e.g., pneumonia, septicemia) ≤ 4 weeks of Screening; infection requiring hospitalization or treatment with intravenous (IV) antibiotics, antivirals, or antifungals within 4 weeks of Screening; or chronic bacterial infection (e.g., tuberculosis) deemed unacceptable as per the Investigator's judgment.
- Had major surgery ≤ 4 weeks before Screening.
- Be currently taking or planning to take strong cytochrome P450 3A4 (CYP3A4) inhibitors or inducers.
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- Be currently taking or have discontinued treatment with riluzole < 4 weeks before Screening. Participants who have been taking a stable dose of riluzole for ≥ 4 weeks are eligible if they remain on the same dose throughout the duration of the study.
- Be taking Radicava (administered orally or IV as approved in the participant's country), Relyvrio, any other approved standard of care treatment, or tauroursodeoxycholic acid (TUDCA) as a dietary supplement administered for < 4 weeks prior to Screening or on a schedule of treatment different from the approved standard schedule of treatment. Participants who have completed ≥ 4 weeks of treatment before Screening are eligible if they plan to continue treatment at a stable dose throughout the duration of the study.
- Have an active malignancy or history (≤ 1 years prior to enrollment) of solid, metastatic, or hematologic malignancy. Exception: basal cell carcinoma in situ of the skin that has been adequately treated.
- Be diagnosed with long QT syndrome. Any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or Torsades de Pointes) should be discussed with and approved by the study medical monitor prior to enrollment.
- Have a prolonged corrected QT interval using Fridericia's formula (QTcF) at the Screening visit ECG > 450 ms for male participants and > 470 ms for female participants.
- Have an active SARS-CoV-2 infection or positive COVID-19 test at Screening.1
- Have one or more of the following laboratory test abnormalities at Screening: (a) Positive hepatitis C virus (HCV) antibodies with confirmation by HCV-RNA polymerase chain reaction (PCR) reflex testing; (b) Positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb). Note: If a participant is negative for HBsAg but positive for HBcAb, the participant is eligible if the participant tests positive for the antibody to HBsAg reflex testing.
- Have uncontrolled seizures.
- Have a documented history of attempted suicide within 6 months prior to the Screening visit, or suicidal ideation of category 4 or 5 on the screening Columbia-Suicide Severity Rating Scale (C-SSRS), or be at significant risk for suicide, in the opinion of the Investigator.
- For participants of childbearing potential, be pregnant or breastfeeding.
- Have received a live vaccine within 14 days before Screening.
- Be concurrently participating in any other interventional clinical study or have received treatment with another investigational drug within 4 weeks or 5 half-lives of the investigational agent before the Screening visit, whichever is longer. Participation in observational studies is allowed.
- Have received stem cell or gene therapy for ALS at any time in the past.
- At the Screening visit, have one or more of the following:
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3.0 × upper limit of normal (ULN)
- Bilirubin > 1.5 × ULN, unless the participant has documented Gilbert syndrome (isolated bilirubin > 1.5 × ULN is acceptable if bilirubin is fractionated and direct bilirubin is < 35%)
- Serum albumin < 3 g/dL
- Hemoglobin < 9.0 g/dL
- Platelets < 30,000/μL
- Estimated glomerular filtration rate < 90 mL/min/1.73 m2 (Modification of Diet in Renal Disease [MDRD])
Trial locations and contacts
7 sites in 4 countries.
7 sites in 4 countries
Finland3 sites
Helsinki University Hospital
Helsinki, Uusimaa, FI-00029
University of Eastern Finland, Brain Research Unit
Kuopio, Eastern Finland, FI-70210
Turku University Hospital
Turku, Western Finland, FI-20520
Canada2 sites
Stan Cassidy Centre for Rehabilitation (Horizon NB)
Montreal, Quebec, H3A 2B4
The Neuro - Montréal Neurological Institute-Hospital
Montreal, Quebec, H3A 2B4
About this study
Official title: A Phase 1b, Open-Label, Multiple Ascending Dose, Multicenter Study of VRG50635 in Participants With Sporadic and Familial Amyotrophic Lateral Sclerosis Followed by Long-Term Treatment
The primary purpose of this study is to evaluate the safety and tolerability of VRG50635 in participants with ALS.
Read the detailed description
This is a Phase 1b, open-label, within-participant, multiple ascending dose, multicenter study of VRG50635 in participants with sporadic amyotrophic lateral sclerosis (sALS) and familial amyotrophic lateral sclerosis (fALS). Part 1 is a pre-treatment run-in period to establish the mean baseline based on repeated measurements of all biomarkers in eligible participants prior to initiating dosing with VRG50635. In Part 2, the safety, tolerability, PK, and efficacy of VRG50635 will be evaluated using a within-participant multiple ascending dose scheme. In Part 3, the long-term tolerability, safety, and efficacy of VRG50635 will be evaluated at the highest tolerated dose.
- Conditions
- Amyotrophic Lateral Sclerosis
- Being tested
- VRG50635
- Keywords
- VRG50635, Familial Amyotrophic Lateral Sclerosis, Sporadic Amyotrophic Lateral Sclerosis, ALS
- Medical subject headings
- Amyotrophic Lateral Sclerosis, Amyotrophic lateral sclerosis 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VRG50635Drug
Part 1, no study drug will be administered.
Part 2, the starting dose is 400 mg for 8 weeks (Treatment Period 1) and doses will be escalated to 600 mg for 8 weeks (Treatment Period 2) and 800 mg for 8 weeks (Treatment Period 3).
Part 3, each participant will continue receiving treatment with the highest tolerated dose achieved in Part 2 for up to 40 weeks.
| Study group | Role | What they receive |
|---|---|---|
| VRG50635 | Experimental | The study drug is VRG50635 200 mg oral capsules. VRG50635 will be administered as oral capsules once daily in the morning after a low-fat meal, approximately 30 minutes prior to VRG50635 administration. Following administration there is a 5 to 6-hour restriction period where participants should consume only low-fat food. Receives: Drug: VRG50635 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Measured: Up to 80 weeks
Number of Participants with Clinical Laboratory Evaluation Abnormalities
Measured: Up to 80 weeks
Number of Participants with Vital Sign Abnormalities
Measured: Up to 80 weeks
Number of Participants with Electrocardiogram (ECG) Abnormalities
Measured: Up to 80 weeks
Number of Participants with Physical Examination Abnormalities
Measured: Up to 80 weeks
Number of Participants with Neurological Examination Abnormalities
Measured: Up to 80 weeks
Secondary outcomes (6)
Maximum Observed Concentration (Cmax)
Measured: Up to 80 weeks
Area Under the Concentration-time Curve (AUC)
Measured: Up to 80 weeks
Time to Maximum Observed Concentration (tmax)
Measured: Up to 80 weeks
Change from Baseline in Plasma Levels of Neurofilament Light Chain (NfL) as Measured by Immunoassay
Measured: Baseline, up to 80 weeks
Time to Disease Progression
Measured: Up to 80 weeks
Change in Harmonized ALS Functional Rating Scale-Revised (ALS-FRS-R) Score
Measured: Up to 80 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2024
- Study start15 Jan 2024
- Primary completion7 Jul 2025
- Study completion7 Jul 2025
Why it stopped: Study terminated by Sponsor due to lack of risk-benefit data.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Amyotrophic Lateral SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Part 1, no study drug will be administered. Part 2, the starting dose is 400 mg for 8 weeks (Treatment Period 1) and doses will be escalated to 600 mg for 8 weeks (Treatment Period 2) and 800 mg for 8 weeks (Treatment Period 3). Part 3, each participant will continue receiving treatment with the highest tolerated dose achieved in Part 2 for up to 40 weeks.
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Verge Genomics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Diego Cadavid, MD, Study director, Verge Genomics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06215755
- Sponsor's protocol ID
- VGCS-50635-002
- Other IDs
- 2023-506509-21, 2023
- Status last verified
- Dec 2025
- First submitted
- 18 Dec 2023
- Last updated
- 15 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hung ST, Linares GR, Chang WH, Eoh Y, Krishnan G, Mendonca S, Hong S, Shi Y, Santana M, Kueth C, Macklin-Isquierdo S, Perry S, Duhaime S, Maios C, Chang J, Perez J, Couto A, Lai J, Li Y, Alworth SV, Hendricks E, Wang Y, Zlokovic BV, Dickman DK, Parker JA, Zarnescu DC, Gao FB, Ichida JK. PIKFYVE inhibition mitigates disease in models of diverse forms of ALS. Cell. 2023 Feb 16;186(4):786-802.e28. doi: 10.1016/j.cell.2023.01.005. Epub 2023 Feb 7.
PubMed 36754049Shi Y, Lin S, Staats KA, Li Y, Chang WH, Hung ST, Hendricks E, Linares GR, Wang Y, Son EY, Wen X, Kisler K, Wilkinson B, Menendez L, Sugawara T, Woolwine P, Huang M, Cowan MJ, Ge B, Koutsodendris N, Sandor KP, Komberg J, Vangoor VR, Senthilkumar K, Hennes V, Seah C, Nelson AR, Cheng TY, Lee SJ, August PR, Chen JA, Wisniewski N, Hanson-Smith V, Belgard TG, Zhang A, Coba M, Grunseich C, Ward ME, van den Berg LH, Pasterkamp RJ, Trotti D, Zlokovic BV, Ichida JK. Haploinsufficiency leads to neurodegeneration in C9ORF72 ALS/FTD human induced motor neurons. Nat Med. 2018 Mar;24(3):313-325. doi: 10.1038/nm.4490. Epub 2018 Feb 5.
PubMed 29400714
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b, Open-Label, Multiple Ascending Dose, Multicenter Study of VRG50635 in Participants With Sporadic and Familial Amyotrophic Lateral Sclerosis Followed by Long-Term Treatment
- ClinicalTrials.gov ID
- NCT06215755
- Acronym / sponsor ID
- VGCS-50635-002
- Conditions
- Amyotrophic Lateral Sclerosis
- Keywords
- VRG50635, Familial Amyotrophic Lateral Sclerosis, Sporadic Amyotrophic Lateral Sclerosis, ALS
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study terminated by Sponsor due to lack of risk-benefit data.
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Verge GenomicsIndustry (pharma, biotech, devices)
- Study start
- 15 Jan 2024 (actual)
- Primary completion
- 7 Jul 2025 (actual)
- Study completion
- 7 Jul 2025 (actual)
- First posted
- 22 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose of this study is to evaluate the safety and tolerability of VRG50635 in participants with ALS.
Detailed description
This is a Phase 1b, open-label, within-participant, multiple ascending dose, multicenter study of VRG50635 in participants with sporadic amyotrophic lateral sclerosis (sALS) and familial amyotrophic lateral sclerosis (fALS). Part 1 is a pre-treatment run-in period to establish the mean baseline based on repeated measurements of all biomarkers in eligible participants prior to initiating dosing with VRG50635. In Part 2, the safety, tolerability, PK, and efficacy of VRG50635 will be evaluated using a within-participant multiple ascending dose scheme. In Part 3, the long-term tolerability, safety, and efficacy of VRG50635 will be evaluated at the highest tolerated dose.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Part 1, no study drug will be administered. Part 2, the starting dose is 400 mg for 8 weeks (Treatment Period 1) and doses will be escalated to 600 mg for 8 weeks (Treatment Period 2) and 800 mg for 8 weeks (Treatment Period 3). Part 3, each participant will continue receiving treatment with the highest tolerated dose achieved in Part 2 for up to 40 weeks.
| Arm | Type | Receives |
|---|---|---|
| VRG50635 | Experimental | Drug: VRG50635The study drug is VRG50635 200 mg oral capsules. VRG50635 will be administered as oral capsules once daily in the morning after a low-fat meal, approximately 30 minutes prior to VRG50635 administration. Following administration there is a 5 to 6-hour restriction period where participants should consume only low-fat food. |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Provide written informed consent and be willing and able to comply with the requirements of the study protocol.
- Must be ≥ 18 and ≤ 75 years of age at the time of signing the informed consent form (ICF).
- Have a diagnosis of ALS according to the Gold Coast Diagnostic Criteria.
- Have either sporadic amyotrophic lateral sclerosis (sALS) or familial amyotrophic lateral sclerosis (fALS).
- Treatment Research Initiative to Cure ALS (TRICALS) risk profile > -6.00 and < -2.00.
Key exclusion criteria (26 listed)
- Have active psychiatric disease, substance abuse, neuromuscular weakness other than ALS, or any other medical condition that, in the opinion of the Investigator, might confound the results of the study or interfere with the intake or absorption of the study drug or participation for the full duration of the study.
- Have a history of unstable or severe cardiac, pulmonary, neurological, oncological, hepatic, or renal disease or another medically significant illness other than ALS precluding their safe participation in this study.
- Have a history of substance use disorder or illicit drug use in the last year (medically prescribed or over-the-counter cannabis use is allowed, if legal in the country).
- Have a history of serious infection (e.g., pneumonia, septicemia) ≤ 4 weeks of Screening; infection requiring hospitalization or treatment with intravenous (IV) antibiotics, antivirals, or antifungals within 4 weeks of Screening; or chronic bacterial infection (e.g., tuberculosis) deemed unacceptable as per the Investigator's judgment.
- Had major surgery ≤ 4 weeks before Screening.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VRG50635Part 1, no study drug will be administered. Part 2, the starting dose is 400 mg for 8 weeks (Treatment Period 1) and doses will be escalated to 600 mg for 8 weeks (Treatment Period 2) and 800 mg for 8 weeks (Treatment Period 3). Part 3, each participant will continue receiving treatment with the highest tolerated dose achieved in Part 2 for up to 40 weeks. | Drug | VRG50635 |
Primary outcome
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Time frame: Up to 80 weeks
Number of Participants with Clinical Laboratory Evaluation Abnormalities
Time frame: Up to 80 weeks
Number of Participants with Vital Sign Abnormalities
Time frame: Up to 80 weeks
Number of Participants with Electrocardiogram (ECG) Abnormalities
Time frame: Up to 80 weeks
Number of Participants with Physical Examination Abnormalities
Time frame: Up to 80 weeks
Number of Participants with Neurological Examination Abnormalities
Time frame: Up to 80 weeks
6 secondary outcomes
Maximum Observed Concentration (Cmax)
Time frame: Up to 80 weeks
Area Under the Concentration-time Curve (AUC)
Time frame: Up to 80 weeks
Time to Maximum Observed Concentration (tmax)
Time frame: Up to 80 weeks
Change from Baseline in Plasma Levels of Neurofilament Light Chain (NfL) as Measured by Immunoassay
Time frame: Baseline, up to 80 weeks
Time to Disease Progression
Time frame: Up to 80 weeks
Change in Harmonized ALS Functional Rating Scale-Revised (ALS-FRS-R) Score
Time frame: Up to 80 weeks
Results and safety
The study was stopped early (reason given: Study terminated by Sponsor due to lack of risk-benefit data.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2025.
- Background: PubMed 36754049Hung ST, Linares GR, Chang WH, Eoh Y, Krishnan G, Mendonca S, Hong S, Shi Y, Santana M, Kueth C, Macklin-Isquierdo S, Perry S, Duhaime S, Maios C, Chang J, Perez J, Couto A, Lai J, Li Y, Alworth SV, Hendricks E, Wang Y, Zlokovic BV, Dickman DK, Parker JA, Zarnescu DC, Gao FB, Ichida JK. PIKFYVE inhibition mitigates disease in models of diverse forms of ALS. Cell. 2023 Feb 16;186(4):786-802.e28. doi: 10.1016/j.cell.2023.01.005. Epub 2023 Feb 7.
- Background: PubMed 29400714Shi Y, Lin S, Staats KA, Li Y, Chang WH, Hung ST, Hendricks E, Linares GR, Wang Y, Son EY, Wen X, Kisler K, Wilkinson B, Menendez L, Sugawara T, Woolwine P, Huang M, Cowan MJ, Ge B, Koutsodendris N, Sandor KP, Komberg J, Vangoor VR, Senthilkumar K, Hennes V, Seah C, Nelson AR, Cheng TY, Lee SJ, August PR, Chen JA, Wisniewski N, Hanson-Smith V, Belgard TG, Zhang A, Coba M, Grunseich C, Ward ME, van den Berg LH, Pasterkamp RJ, Trotti D, Zlokovic BV, Ichida JK. Haploinsufficiency leads to neurodegeneration in C9ORF72 ALS/FTD human induced motor neurons. Nat Med. 2018 Mar;24(3):313-325. doi: 10.1038/nm.4490. Epub 2018 Feb 5.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Diego Cadavid, MD study director
Verge Genomics
7 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing VRG50635 in people with Amyotrophic Lateral Sclerosis, run by Verge Genomics at 7 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Finland, Canada, Belgium, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Study terminated by Sponsor due to lack of risk-benefit data.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Treatment-emergent Adverse Events (TEAEs) (time frame: Up to 80 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06215755, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2025.