Amyotrophic Lateral SclerosisPhase 2NCT05981040
Efficacy, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ZYIL1 in Patients With Amyotrophic Lateral Sclerosis
A Phase 2 study testing ZYIL1 capsules 25 mg and ZYIL1 capsules 50 mg in people with Amyotrophic Lateral Sclerosis, run by Zydus Lifesciences Limited at 7 sites in India.
Trial summary
ZYIL1 is expected to show benefit in patients with Amyotrophic Lateral Sclerosis (ALS). The present study aims to determine the safety, tolerability, pharmacokinetics, and pharmacodynamics of ZYIL1 when administered to subjects with ALS. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Amyotrophic Lateral Sclerosis
- What is being tested?
- ZYIL1 capsules 25 mg and ZYIL1 capsules 50 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 7 sitesIndia
- Study dates
- 9 Nov 2023to 26 Jun 2024
- Phase
- Phase 2
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and/or female patients aged between 18 and 80 years (inclusive at screening).
- Diagnosis of probable or definite ALS, according to the revised version of the El Escorial World Federation of Neurology criteria. Refer Appendix III - El Escorial Criteria.
- Time since onset of first symptom of ALS ≤9 months
- Slow Vital Capacity (SVC) ≥ 50% of the predicted value
- Be able to swallow the study capsules during study
- Either not currently receiving riluzole or on a stable dose of riluzole for at least 4 weeks before the screening visit. Participants receiving riluzole are expected to remain on the same dose throughout the duration of the study
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- Either not currently receiving edaravone or on edaravone treatment. Participants receiving edaravone must have completed at least 1 cycle of treatment before the screening visit and are expected to continue with stable dose edaravone treatment throughout the duration of the study.
- Female patients must be non-pregnant, non-lactating and women of child-bearing potential/ sexually active women, unless surgically sterile (at least 6 months prior to study drug administration) or postmenopausal* for at least 12 consecutive months, must agree to use adequate contraception (hormonal contraceptives [combined estrogen and progestogen oral contraceptive, patch, contraceptive vaginal ring, injectable progestogen, and implants] or contraceptive subdermal implant or percutaneous contraceptive patches or intrauterine device [IUD] or intrauterine system [IUS]; vasectomy and tubal ligation or barrier method of birth control; female condom with spermicide, cervical cap, diaphragm with spermicide, contraceptive sponge), absolute sexual abstinence, use of condom with spermicide by sexual partner or sterile [at least 6 months prior to study drug administration], during study and up to 32 days after the last dose of study drug.
- Postmenopausal defined as 12 months of spontaneous amenorrhea with an appropriate clinical profile (e.g., age appropriate, >45 years, in the absence of hormone replacement therapy).
- All male patients should avoid fathering a child by either true abstinence, hormonal or barrier method (e.g., male condom with diaphragm, male condom with cervical cap) or with their sexual partner the use of effective means of contraception throughout and till 92 days of administration of the last dose. They must not donate sperm for at least 92 days after the last dose of study drug.
- Ability to provide written informed consent and to be compliant with the schedule of protocol assessments. In case of illiterate patients, thumb impression of the patients will be obtained along with the signature of the impartial witness or legally authorized representative (LAR) on the consent form prior to patient's participation in the trial.Date of ALS Symptom Onset. For the purposes of this study, the date of symptom onset will be defined as the date the subject first had symptoms of their disease, i.e., weakness. To be eligible for this study, the date of symptom onset must be no greater than exactly 9 months prior to the Screening Visit date.
Who cannot join
- With significant cognitive impairment, psychiatric disease, other neurodegenerative disorder (e.g., Parkinson disease or AD), substance abuse other causes of neuromuscular weakness, or any other condition that would make the participants unsuitable for participating in the study or could interfere with assessment or completing the study in the opinion of the Investigator.
- History of recent serious infection (e.g., pneumonia, septicemia) within 4 weeks of the screening visit; infection requiring hospitalization or treatment with IV antibiotics, antivirals, or antifungals within 4 weeks of screening; or chronic bacterial infection (such as tuberculosis) deemed unacceptable as per the Investigator's judgment
- With active herpes zoster infection within 2 months prior to the screening visit
- A documented history of attempted suicide within 6 months prior to the screening visit, or in the Investigator's judgment are at risk for a suicide attempt
- History of unstable or severe cardiac, pulmonary, oncological, hepatic, or renal disease or another medically significant illness other than ALS precluding their safe participation in this study
- Participants who are pregnant or are currently breastfeeding
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- A known history of allergy to any ingredients of ZYIL1
- Patients taking concomitant medicines within 7 days or 5 half-lives of the medication (whichever is longer) prior to first dose of study drug administration till end of the study, which are substrate of CYP1A2 enzymes (e.g., alosetron, caffeine, duloxetine, melatonin, ramelteon, tasimelteon, tizanidine etc.) and CYP2B6 enzymes (e.g., bupropion, efavirenz etc.).
- Use of any steroids, colchicine or anti-IL-1 inhibitors within 7 days or 5 half-lives of the medication (whichever is longer) prior to first dose of study drug administration.
- Use of any investigational drugs concurrently or within 4 weeks or 5 half-lives (whichever is longer), prior to first dose of study drug administration.
- Any clinically significant and/or laboratory significant value or other instability that would prevent the patient from participating in the study as determined by the Investigator.
- Received a live vaccine within 14 days before the screening visit or planning to receive during the study
- Participants who have received stem cell or gene therapy for ALS at any time in the past
- Any of the following laboratory values at screening
- 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%)
- Estimated glomerular filtration rate <60 mL/min/1.73 m2 (Modification of Diet in Renal Disease [MDRD])
- QT interval corrected for heart rate using Fridericia's method (QTcF) > 450 msec at screening.
- Contraindications to lumbar puncture including but not limited to lumbar scoliosis, coagulopathy, infection at site of puncture, use of anticoagulants at the time of study enrolment.
- Participant with seizure disorder or history of seizures within 6 months.
- Surgery within last 3 months or planned major surgery within next 3 months from the date of screening (other than minor cosmetic surgery and minor dental surgery).
- Use or intended use of any medications/products known to alter drug absorption, metabolism, or elimination processes including St John's Wort within 4 weeks prior to receiving study drug and up to end of study. Use of such medication will be considered on a case-by-case basis as per the opinion of the Investigator and/or independent medical monitor.
- Use of grapefruit or similar substances (Seville oranges or marmalade, grapefruit juice, grapefruit hybrids, pomelos, exotic citrus fruits or fruit juices) within 7 days prior to first dose of study drug until last dose administration.
- Donation of blood or blood products within 3 months prior to screening.
- History of, or positive screening test for, hepatitis C infection (defined as positive for hepatitis C virus antibody), hepatitis B infection (defined as positive for hepatitis B surface antigen), or human immunodeficiency virus I or II.
- Use or intended use of any over-the-counter (vitamins, minerals, and phytotherapeutic/herbal/plant-derived preparations) or prescription medications within 7 days or 5 half-lives (whichever is longer) prior to receiving study drug, with the exception of hormone replacement therapy and therapies for chronic stable diseases that have been stable for at least 30 days prior to screening and until Day 1, unless deemed acceptable by the Investigator.
- Inability to be venipunctured or tolerate venous puncture.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
India7 sites
Zydus Hospitals & Healthcare Research
Ahmedabad, Gujarat
BrainS Super Speciality Hospital
Bengaluru, Karnataka
KIMS-Kingsway Hospitals
Nagpur, Maharashtra
Surya Multispecialty Hospital
Nashik, Maharashtra, 422003
Sir Ganga Ram Hospital
New Delhi
CIMET's Inamdar Multispeciality Hospital
Pune, Maharashtra
Rhythm heart institute
Vadodara, Gujarat
About this study
Official title: A Phase 2, Proof-of-concept, Placebo Controlled, Randomized, Multi-centre, Double Blind Study of ZYIL1 to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics in Patients With Amyotrophic Lateral Sclerosis (ALS)
ZYIL1 is expected to show benefit in patients with Amyotrophic Lateral Sclerosis (ALS). The present study aims to determine the safety, tolerability, pharmacokinetics, and pharmacodynamics of ZYIL1 when administered to subjects with ALS.
Read the detailed description
This is a proof-of-concept, placebo controlled, randomized, multi-centre,double blind study designed to evaluate the efficacy, safety, tolerability, pharmacokinetics, and pharmacodynamics in patients with Amyotrophic Lateral Sclerosis following a twice daily oral administration of ZYIL1 or matching placebo to patients aged between 18 and 80 years (inclusive at screening).
Treatment duration will be twelve (12) weeks.
- Conditions
- Amyotrophic Lateral Sclerosis
- Being tested
- ZYIL1 capsules 25 mg and 50 mg Placebo, ZYIL1 capsules 50 mg and 25 mg Placebo, ZYIL1 capsules 25 mg and ZYIL1 capsules 50 mg, Matching placebo 25 mg and Matching placebo 50 mg
- Medical subject headings
- Amyotrophic Lateral Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZYIL1 capsules 25 mg and 50 mg PlaceboDrug
ZYIL1 capsules 25 mg for oral administration + matching placebo of 50 mg ZYIL1 capsule
ZYIL1 capsules 50 mg and 25 mg PlaceboDrug
ZYIL1 capsules 50 mg for oral administration + matching placebo of 25 mg ZYIL1 capsule
ZYIL1 capsules 25 mg and ZYIL1 capsules 50 mgDrug
ZYIL1 capsules 25 mg for oral administration + ZYIL1 capsules 50 mg for oral administration
Matching placebo 25 mg and Matching placebo 50 mgDrug
Matching placebo of 25 mg ZYIL1 capsule + Matching placebo of 50 mg ZYIL1 capsule
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Active comparator | ZYIL1 capsules 25 mg for oral administration + matching placebo of 50 mg ZYIL1 capsule Receives: Drug: ZYIL1 capsules 25 mg and 50 mg Placebo |
| Arm 2 | Active comparator | ZYIL1 capsules 50 mg for oral administration + matching placebo of 25 mg ZYIL1 capsule Receives: Drug: ZYIL1 capsules 50 mg and 25 mg Placebo |
| Arm 3 | Active comparator | ZYIL1 capsules 25 mg for oral administration + ZYIL1 capsules 50 mg for oral administration Receives: Drug: ZYIL1 capsules 25 mg and ZYIL1 capsules 50 mg |
| Arm 4 | Placebo comparator | Matching placebo of 25 mg ZYIL1 capsule + Matching placebo of 50 mg ZYIL1 capsule Receives: Drug: Matching placebo 25 mg and Matching placebo 50 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in the ALSFRS-R total score
Measured: From baseline to Week 12
Secondary outcomes (8)
Time from baseline to the occurrence of either death, or permanent assisted ventilation
Measured: Baseline to Week 12 (>22 hours daily for >7 consecutive days), whichever comes first )
Change from baseline in slow vital capacity (SVC)
Measured: Baseline to Week 12
Change from baseline in serum neurofilament light chain biomarker
Measured: Baseline to Week 12
Number of patients with treatment emergent adverse events
Measured: Baseline to Week 12
Number of patients with Serious adverse event (SAE)
Measured: Baseline to Week 12
Cmax
Measured: baseline to Week 12
AUC
Measured: baseline to Week 12
Tmax
Measured: baseline to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2023
- Study start9 Nov 2023
- Primary completion26 Jun 2024
- Study completion26 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zydus Lifesciences Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr. Deven Parmar, MD,FCP, Study chair, Zydus Therapeutics Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05981040
- Sponsor's protocol ID
- ZYIL1.23.003
- Status last verified
- Dec 2024
- First submitted
- 31 Jul 2023
- Last updated
- 19 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yeole A, Khanna L, Doshi M, Sharma A, Uttarwar P, Doshi S, Kaushik Kumar R, Venkataramana N, Parmar D. A phase 2, proof-of-concept, placebo-controlled, randomized, multicenter, double-blind study to evaluate the efficacy, safety, tolerability, pharmacokinetics, and pharmacodynamics of Usnoflast (ZYIL1) in patients with amyotrophic lateral sclerosis. Amyotroph Lateral Scler Frontotemporal Degener. 2025 Nov;26(7-8):794-801. doi: 10.1080/21678421.2025.2515900. Epub 2025 Jun 13.
PubMed 40511876
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Proof-of-concept, Placebo Controlled, Randomized, Multi-centre, Double Blind Study of ZYIL1 to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics in Patients With Amyotrophic Lateral Sclerosis (ALS)
- ClinicalTrials.gov ID
- NCT05981040
- Acronym / sponsor ID
- ZYIL1.23.003
- Conditions
- Amyotrophic Lateral Sclerosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Zydus Lifesciences LimitedIndustry (pharma, biotech, devices)
- Study start
- 9 Nov 2023 (actual)
- Primary completion
- 26 Jun 2024 (actual)
- Study completion
- 26 Jun 2024 (actual)
- First posted
- 8 Aug 2023 (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.
ZYIL1 is expected to show benefit in patients with Amyotrophic Lateral Sclerosis (ALS). The present study aims to determine the safety, tolerability, pharmacokinetics, and pharmacodynamics of ZYIL1 when administered to subjects with ALS.
Detailed description
This is a proof-of-concept, placebo controlled, randomized, multi-centre,double blind study designed to evaluate the efficacy, safety, tolerability, pharmacokinetics, and pharmacodynamics in patients with Amyotrophic Lateral Sclerosis following a twice daily oral administration of ZYIL1 or matching placebo to patients aged between 18 and 80 years (inclusive at screening).
Treatment duration will be twelve (12) weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Active comparator | Drug: ZYIL1 capsules 25 mg and 50 mg PlaceboZYIL1 capsules 25 mg for oral administration + matching placebo of 50 mg ZYIL1 capsule |
| Arm 2 | Active comparator | Drug: ZYIL1 capsules 50 mg and 25 mg PlaceboZYIL1 capsules 50 mg for oral administration + matching placebo of 25 mg ZYIL1 capsule |
| Arm 3 | Active comparator | Drug: ZYIL1 capsules 25 mg and ZYIL1 capsules 50 mgZYIL1 capsules 25 mg for oral administration + ZYIL1 capsules 50 mg for oral administration |
| Arm 4 | Placebo comparator | Drug: Matching placebo 25 mg and Matching placebo 50 mgMatching placebo of 25 mg ZYIL1 capsule + Matching placebo of 50 mg ZYIL1 capsule |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Male and/or female patients aged between 18 and 80 years (inclusive at screening).
- Diagnosis of probable or definite ALS, according to the revised version of the El Escorial World Federation of Neurology criteria. Refer Appendix III - El Escorial Criteria.
- Time since onset of first symptom of ALS ≤9 months
- Slow Vital Capacity (SVC) ≥ 50% of the predicted value
- Be able to swallow the study capsules during study
Key exclusion criteria (27 listed)
- With significant cognitive impairment, psychiatric disease, other neurodegenerative disorder (e.g., Parkinson disease or AD), substance abuse other causes of neuromuscular weakness, or any other condition that would make the participants unsuitable for participating in the study or could interfere with assessment or completing the study in the opinion of the Investigator.
- History of recent serious infection (e.g., pneumonia, septicemia) within 4 weeks of the screening visit; infection requiring hospitalization or treatment with IV antibiotics, antivirals, or antifungals within 4 weeks of screening; or chronic bacterial infection (such as tuberculosis) deemed unacceptable as per the Investigator's judgment
- With active herpes zoster infection within 2 months prior to the screening visit
- A documented history of attempted suicide within 6 months prior to the screening visit, or in the Investigator's judgment are at risk for a suicide attempt
- History of unstable or severe cardiac, pulmonary, oncological, hepatic, or renal disease or another medically significant illness other than ALS precluding their safe participation in this study
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 |
|---|---|---|
| ZYIL1 capsules 25 mg and 50 mg PlaceboZYIL1 capsules 25 mg for oral administration + matching placebo of 50 mg ZYIL1 capsule | Drug | Arm 1 |
| ZYIL1 capsules 50 mg and 25 mg PlaceboZYIL1 capsules 50 mg for oral administration + matching placebo of 25 mg ZYIL1 capsule | Drug | Arm 2 |
| ZYIL1 capsules 25 mg and ZYIL1 capsules 50 mgZYIL1 capsules 25 mg for oral administration + ZYIL1 capsules 50 mg for oral administration | Drug | Arm 3 |
| Matching placebo 25 mg and Matching placebo 50 mgMatching placebo of 25 mg ZYIL1 capsule + Matching placebo of 50 mg ZYIL1 capsule | Drug | Arm 4 |
Primary outcome
Change from baseline in the ALSFRS-R total score
Time frame: From baseline to Week 12
8 secondary outcomes
Time from baseline to the occurrence of either death, or permanent assisted ventilation
Time frame: Baseline to Week 12 (>22 hours daily for >7 consecutive days), whichever comes first )
Change from baseline in slow vital capacity (SVC)
Time frame: Baseline to Week 12
Change from baseline in serum neurofilament light chain biomarker
Time frame: Baseline to Week 12
Number of patients with treatment emergent adverse events
Time frame: Baseline to Week 12
Number of patients with Serious adverse event (SAE)
Time frame: Baseline to Week 12
Cmax
Time frame: baseline to Week 12
AUC
Time frame: baseline to Week 12
Tmax
Time frame: baseline to Week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2024.
- Derived from this study: PubMed 40511876Yeole A, Khanna L, Doshi M, Sharma A, Uttarwar P, Doshi S, Kaushik Kumar R, Venkataramana N, Parmar D. A phase 2, proof-of-concept, placebo-controlled, randomized, multicenter, double-blind study to evaluate the efficacy, safety, tolerability, pharmacokinetics, and pharmacodynamics of Usnoflast (ZYIL1) in patients with amyotrophic lateral sclerosis. Amyotroph Lateral Scler Frontotemporal Degener. 2025 Nov;26(7-8):794-801. doi: 10.1080/21678421.2025.2515900. Epub 2025 Jun 13.
- 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.
Dr. Deven Parmar, MD,FCP study chair
Zydus Therapeutics Inc.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ZYIL1 capsules 25 mg and ZYIL1 capsules 50 mg in people with Amyotrophic Lateral Sclerosis, run by Zydus Lifesciences Limited at 7 sites in India.
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 11 inclusion and 27 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: finished, as of the sponsor's last update on 19 Dec 2024. 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 India. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change from baseline in the ALSFRS-R total score (time frame: From baseline to Week 12). 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 NCT05981040, which also lists 1 linked publication.
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 19 Dec 2024.