Diabetes Mellitus, Type 1Phase 2IMPACTNCT04524949
IMCY-0098 Proof of ACtion in Type 1 Diabetes (IMPACT Study)
A Phase 2 study testing IMCY-0098 450 μg and IMCY-0098 1350 μg in people with Diabetes Mellitus, Type 1, run by Imcyse SA at 29 sites in 8 countries.
Trial summary
The IMPACT study is a study to test a new experimental drug, IMCY-0098, for the treatment of type 1 diabetes (T1D). In most people with type 1 diabetes, the pancreas loses its ability to make insulin because some cells of the body's own immune system mistakenly attack and destroy the cells in the pancreas that produce… Read more about this study
- Who is it for?
- Ages 18 to 44 years
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- IMCY-0098 450 μg and IMCY-0098 1350 μg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 29 sitesin 8 countries
- Study dates
- 29 Dec 2020to 29 May 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 44 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Have given written informed consent.
- Participants aged ≥ 18 years and < 45 years at the time of consent
- Have a diagnosis of T1D within maximum 9 weeks at screening (date of the first insulin injection)
- Must have at least one or more diabetes-related autoantibodies present at screening (GAD65, IA-2, or ZnT8)
- Must have random C-peptide levels ≥ 200 pmol/L measured at screening
- Must be Human Leukocyte Antigen (HLA) DR4 positive to participate in the main study OR HLA DR4 negative but HLA DR3 positive to participate in the substudy
Show all 13Show fewer
- Be willing to comply with intensive diabetes management
- Be treated with insulin therapy in accordance with the local standard of care
- Males with reproductive potential must agree to use adequate contraception up to 90 days after the completion of the last treatment. This includes:
- Barrier contraception (condom and spermicide) or
- True abstinence (where this is in accordance with the participants preferred and usual lifestyle)
- All females must have a negative serum pregnancy test at screening. Women sexually active and of childbearing potential must agree to use a highly effective contraception method from screening up to 90 days after last treatment with the investigational product
- (US ONLY) Have HbA1c levels ≤ 9.5% prior to randomization
Who cannot join
- Clinically significant abnormal full blood count (FBC), renal function or liver function at screening including
- 1.1. Be immunodeficient or have any clinically significant chronic lymphopenia: Leukopenia (< 3,000 leukocytes /μL), neutropenia (<1,500 neutrophils/μL), lymphopenia (<800 lymphocytes/μL), or thrombocytopenia (<100,000 platelets/μL)
- 1.2. Evidence of renal dysfunction with serum creatinine greater than 1.5 times the upper limit of normal OR (US ONLY) estimated Glomerular Filtration Rate (eGFR) calculated by Chronic Kidney Disease Epidemiology Collaboration (CKD-Epi) <90 mL/min per 1.73 m2 in absence of other signs of CKD or rapidly progressing renal disease
- 1.3. Evidence of liver dysfunction with aspartate aminotransferase (AST) or alanine transaminase (ALT) greater than 3 times the upper limits of normal or (US ONLY) total bilirubin ≥ 2x Upper Limit of Normal (ULN) or Alkaline phosphatase ≥ 2x ULN. For participants presenting with values above ULN but below above threshold for these parameters, the underlying reason should be investigated by the site team to exclude liver disease. Patients for which a liver disease would be diagnosed will be excluded from the study.
- Participants with elevated unconjugated bilirubin (Gilbert's syndrome) are eligible if bilirubin is ≤ 3 times the upper limits of normal and hepatic enzymes and function are otherwise normal (AST/ALT/Alkaline phosphatase within ULN), and there is no evidence of hemolysis
- Have signs or symptoms of serious active infection requiring IV antibiotics and/or hospitalization at study entry
Show all 26Show fewer
- Have signs or symptoms of active COVID infection or a positive COVID PCR test during the screening period
- Have received any live attenuated vaccine within 3 months prior to the first planned administration of the study product (which includes, but is not limited to: oral poliomyelitis vaccine, measles-mumps-rubella vaccine, yellow fever vaccine, Japanese encephalitis vaccine, dengue vaccine, rotavirus vaccine, varicella vaccine, live-attenuated zoster vaccine, Bacillus Calmette-Guérin [BCG] vaccine, oral typhoid vaccine)
- Be currently pregnant or lactating, or anticipate getting pregnant until at least 24 weeks after last study drug administration
- Require the use of immunosuppressive agents including chronic use of systemic steroids. Topical, inhalational or intranasal corticosteroids are allowed
- Have evidence of current or past human immunodeficiency virus (HIV), Hepatitis B or Hepatitis C infection
- Presence of any uncontrolled disease (including uncontrolled autoimmune disease) or abnormal clinical laboratory results that may interfere with study conduct as judged by the investigator
- History of, or current malignancy (except excised basal cell skin cancer)
- Current or ongoing use of non-insulin pharmaceuticals that affect glycaemic control within 7 days prior to screening visit
- Active participation in another T1D treatment study or any investigational intervention study in the previous 30 days or (US ONLY) received gene therapy in the past
- Known hypersensitivity to any component of the drug product
- CRO or Sponsor employees or employees under the direct supervision of the Investigator and/or involved directly in the study
- Be diagnosed with Latent Autoimmune Diabetes in Adults (LADA)
- (US ONLY) History or current evidence of hematologic condition that would make HbA1c uninterpretable including:
- 15.1. Grade 1 anemia, defined as: Hemoglobin (Hb) < Lower Limit of Normal (LLN) - 10.0 g/dL or < LLN - 6.2 mmol/L or < LLN - 100 g/L
- 15.2. Hemoglobinopathy, with the exception of sickle cell trait or thalassemia minor; or chronic or recurrent hemolysis
- 15.3. Donation of blood or blood products to a blood bank, blood transfusion or participation in a clinical study requiring withdrawal of > 400 mL of blood during the 90 days prior to the Screening visit
- 15.4. Significant iron deficiency anemia
- 15.5. Heart malformations or Vaso-Occlusive Crisis (VOC) leading to increased turnover of erythrocytes
- (US ONLY) Current evidence of hypertension defined as the mean (average) of Diastolic Blood Pressure (DBP) > 89 mm Hg or Systolic Blood Pressure (SBP) > 129 mm Hg based on 3 consecutive readings at least 2 minutes apart
- (US ONLY) History or current evidence of active drug, chemical or alcohol dependency.
Trial locations and contacts
29 sites in 8 countries.
29 sites in 8 countries
United Kingdom11 sites
Addenbrooke's Hospital
Cambridge
University Hospital of Wales
Cardiff
Royal Infirmary of Edinburgh
Edinburgh
Royal Devon and Exeter Hospital
Exeter
St James´s University Hospital
Leeds
Leicester General Hospital
Leicester
Guy's and St Thomas' Hospital
London
Royal London Hospital
London
St George's Hospital
London
Royal Victoria Infirmary
Newcastle
Churchill Hospital
Oxford
United States4 sites
Barbara Davis Center
Aurora, Colorado, 80045
University of Alabama at Birmingham
Birmingham, Alabama, 35205
Joslin Diabetes Center
Boston, Massachusetts, 02215
University of Chicago
Chicago, Illinois, 60637
Australia4 sites
Princess Alexandra Hospital
Brisbane
Royal Melbourne Hospital
Melbourne
St. Vincent's Hospital
Melbourne
Royal North Shore Hospital
Sydney
Belgium3 sites
Université Libre de Bruxelles - Hôpital Erasme - ULB
Brussels
UZ Brussels
Brussels
Katholieke Universiteit Leuven UZ Gasthuisberg
Leuven
Lithuania3 sites
Hospital of Lithuanian University of Health Sciences Kauno Klinikos
Kaunas
Klaipeda university hospital
Klaipėda
Vilnius university hospital Santaros klinikos
Vilnius
Italy2 sites
Ospedale San Raffaele S.r.l.
Milan
AOU Pisana - Ospedale Cisanello
Pisa
About this study
Official title: A Phase IIa, Randomized, Double-blind, Dose Comparison, Placebo-controlled, Multi-centre Clinical Trial to Evaluate the Immune Signature of the Treatment With the Imotope IMCY-0098 and Its Effect on the Preservation of Beta-cell Function in Adult Patients With a Recent Onset Type 1 Diabetes
The IMPACT study is a study to test a new experimental drug, IMCY-0098, for the treatment of type 1 diabetes (T1D).
In most people with type 1 diabetes, the pancreas loses its ability to make insulin because some cells of the body's own immune system mistakenly attack and destroy the cells in the pancreas that produce insulin (islet beta-cells).
Read more
The study drug IMCY-0098 is being developed to stop the body's own immune system attacking and destroying the insulin-producing cells. When injected, it will induce new immune cells that will specifically destroy the bad immune cells responsible for the damage to the pancreas.
IMCY-0098 has previously been tested on recently diagnosed type 1 diabetes patients in the first clinical study between 2017 and 2019 to collect information on the safety of IMCY-0098. The next step is to test the best dose and the best number of injections that show the drug can give a benefit. Two doses of IMCY-0098 will be tested and they will be compared to a placebo. Safety information will also be collected during the study for all the participants.
Read the detailed description
The main study will include 84 HLA DR4+ patients. In addition, up to 24 HLA DR4-/DR3+ patients will be included in a mechanistic substudy.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- IMCY-0098 450 μg, IMCY-0098 1350 μg, Placebo
- Keywords
- Diabetes Mellitus Type 1, Autoimmune disease, Immunotherapy, Diabetes treatment
- Medical subject headings
- Diabetes Mellitus, Type 1, Autoimmune Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMCY-0098 450 μgDrug
Also called Imotope
Small synthetic peptide for SC admin. Solvent: alum hydroxide
IMCY-0098 1350 μgDrug
Also called Imotope
Small synthetic peptide for SC admin. Solvent: alum hydroxide
PlaceboDrug
Solvent: alum hydroxide
| Study group | Role | What they receive |
|---|---|---|
| IMCY-0098, low dose | Experimental | The dose A (Cohort 1) will consist of subcutaneous administrations of 450 µg of the peptide in two separate injections of 225 µg each (500 µL each). Receives: Drug: IMCY-0098 450 μg |
| IMCY-0098, high dose | Experimental | The dose B (Cohort 2) will consist of subcutaneous administrations of 1350 µg of the peptide in two separate injections of 675 µg each (500 µL each). Receives: Drug: IMCY-0098 1350 μg |
| Placebo | Placebo comparator | Participants randomized to placebo will receive subcutaneous administrations of identical volumes of placebo solution to maintain study blind. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in stimulated C-peptide response during the first two hours of a mixed meal tolerance test (MMTT) from baseline to 48 weeks between IMCY-0098 and placebo groups
The area under the stimulated C-peptide response curve over the first two hours of a MMTT
Measured: From baseline to 48 weeks
Secondary outcomes (12)
Changes in stimulated C-peptide response during the first two hours of a MMTT for the two doses of IMCY-0098 versus placebo
The area under the stimulated C-peptide response curve over the first two hours of a MMTT
Measured: From baseline to 24 months
Difference in Dried Blood Spots (DBS) fasted C-peptide between treatment and placebo groups
DBS C-peptide measurements
Measured: From baseline to 48 weeks
Changes in DBS C-peptide measurements at each visit comparing each dose with placebo
The DBS C-peptide responses at each visit
Measured: From baseline to 24 months
Effects of each dose of IMCY-0098 on HbA1c
Change in HbA1c
Measured: From baseline to 24 months
Effects of each dose of IMCY-0098 on hypoglycaemic events
Number of treatment-emergent severe hypoglycaemic episodes
Measured: From baseline to 24 months
Effects of each dose of IMCY-0098 on diabetic ketoacidosis (DKA) episodes
Number of treatment-emergent episodes of DKA
Measured: From baseline to 24 months
Effects of each dose of IMCY-0098 on daily total insulin dose
Change in insulin requirements as the daily total dose (three days average) in units per kg body weight
Measured: From baseline to 24 months
Effects of each dose of IMCY-0098 on Continuous Glucose Monitoring (CGM) measures
CGM time in range (70-180 mg/dL, 3.9- 10.0 mmol/L), time above range (>180 mg/dL, >10.0 mmol/L), time below range (<70 mg/dL, < 3.9 mmol/L) during 10 days compared to the reference period (first 10 days after randomization)
Measured: From baseline to 24 months
Impact of IMCY-0098 at each dose on autoantibodies against GAD65, IA 2, ZnT8 and insulin over time
Change in T1D associated autoantibodies (GADA, IAA, IA-2A and ZnT8A)
Measured: From baseline to 24 months
To evaluate the safety features of IMCY-0098 during treatment period
Occurrence, intensity and relationship of any listed injection site and systemic AEs during a 7-day follow-up period after each dose
Measured: Up to 7 days after the last dose
To evaluate the safety features of IMCY-0098 during the whole study duration
Occurrence, intensity and relationship of any unlisted injection site and AEs and occurrence and relationship of all SAEs and abnormality in physical examination, vital signs, 12-lead ECG
Measured: Up to 48 weeks
To evaluate the safety features of IMCY-0098 on lymphocytes ratio
Measure of CD4+/CD8+ lymphocytes ratio
Measured: Up to 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2020
- Study start29 Dec 2020
- Primary completion26 Jan 2024
- Study completion29 May 2024
Why it stopped: No efficacy at primary analysis after 1 year. Long term follow-up stopped
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 1Studies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imcyse SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jean Van Rampelbergh, Study director, Imcyse SA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04524949
- Sponsor's protocol ID
- IMCY-T1D-003
- Other IDs
- 2020-001317-20
- Acronym
- IMPACT
- Status last verified
- Jun 2024
- First submitted
- 11 Aug 2020
- Last updated
- 24 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIa, Randomized, Double-blind, Dose Comparison, Placebo-controlled, Multi-centre Clinical Trial to Evaluate the Immune Signature of the Treatment With the Imotope IMCY-0098 and Its Effect on the Preservation of Beta-cell Function in Adult Patients With a Recent Onset Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT04524949
- Acronym / sponsor ID
- IMPACT / IMCY-T1D-003
- Conditions
- Diabetes Mellitus, Type 1
- Keywords
- Diabetes Mellitus Type 1, Autoimmune disease, Immunotherapy, Diabetes treatment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: No efficacy at primary analysis after 1 year. Long term follow-up stopped
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Imcyse SAIndustry (pharma, biotech, devices)
- Study start
- 29 Dec 2020 (actual)
- Primary completion
- 26 Jan 2024 (actual)
- Study completion
- 29 May 2024 (actual)
- First posted
- 24 Aug 2020 (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 IMPACT study is a study to test a new experimental drug, IMCY-0098, for the treatment of type 1 diabetes (T1D).
In most people with type 1 diabetes, the pancreas loses its ability to make insulin because some cells of the body's own immune system mistakenly attack and destroy the cells in the pancreas that produce insulin (islet beta-cells).
The study drug IMCY-0098 is being developed to stop the body's own immune system attacking and destroying the insulin-producing cells. When injected, it will induce new immune cells that will specifically destroy the bad immune cells responsible for the damage to the pancreas.
IMCY-0098 has previously been tested on recently diagnosed type 1 diabetes patients in the first clinical study between 2017 and 2019 to collect information on the safety of IMCY-0098. The next step is to test the best dose and the best number of injections that show the drug can give a benefit. Two doses of IMCY-0098 will be tested and they will be compared to a placebo. Safety information will also be collected during the study for all the participants.
Detailed description
The main study will include 84 HLA DR4+ patients. In addition, up to 24 HLA DR4-/DR3+ patients will be included in a mechanistic substudy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| IMCY-0098, low dose | Experimental | Drug: IMCY-0098 450 μgThe dose A (Cohort 1) will consist of subcutaneous administrations of 450 µg of the peptide in two separate injections of 225 µg each (500 µL each). |
| IMCY-0098, high dose | Experimental | Drug: IMCY-0098 1350 μgThe dose B (Cohort 2) will consist of subcutaneous administrations of 1350 µg of the peptide in two separate injections of 675 µg each (500 µL each). |
| Placebo | Placebo comparator | Drug: PlaceboParticipants randomized to placebo will receive subcutaneous administrations of identical volumes of placebo solution to maintain study blind. |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Have given written informed consent.
- Participants aged ≥ 18 years and < 45 years at the time of consent
- Have a diagnosis of T1D within maximum 9 weeks at screening (date of the first insulin injection)
- Must have at least one or more diabetes-related autoantibodies present at screening (GAD65, IA-2, or ZnT8)
- Must have random C-peptide levels ≥ 200 pmol/L measured at screening
Key exclusion criteria (26 listed)
- Clinically significant abnormal full blood count (FBC), renal function or liver function at screening including
- 1.1. Be immunodeficient or have any clinically significant chronic lymphopenia: Leukopenia (< 3,000 leukocytes /μL), neutropenia (<1,500 neutrophils/μL), lymphopenia (<800 lymphocytes/μL), or thrombocytopenia (<100,000 platelets/μL)
- 1.2. Evidence of renal dysfunction with serum creatinine greater than 1.5 times the upper limit of normal OR (US ONLY) estimated Glomerular Filtration Rate (eGFR) calculated by Chronic Kidney Disease Epidemiology Collaboration (CKD-Epi) <90 mL/min per 1.73 m2 in absence of other signs of CKD or rapidly progressing renal disease
- 1.3. Evidence of liver dysfunction with aspartate aminotransferase (AST) or alanine transaminase (ALT) greater than 3 times the upper limits of normal or (US ONLY) total bilirubin ≥ 2x Upper Limit of Normal (ULN) or Alkaline phosphatase ≥ 2x ULN. For participants presenting with values above ULN but below above threshold for these parameters, the underlying reason should be investigated by the site team to exclude liver disease. Patients for which a liver disease would be diagnosed will be excluded from the study.
- Participants with elevated unconjugated bilirubin (Gilbert's syndrome) are eligible if bilirubin is ≤ 3 times the upper limits of normal and hepatic enzymes and function are otherwise normal (AST/ALT/Alkaline phosphatase within ULN), and there is no evidence of hemolysis
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 |
|---|---|---|
| IMCY-0098 450 μgAlso: ImotopeSmall synthetic peptide for SC admin. Solvent: alum hydroxide | Drug | IMCY-0098, low dose |
| IMCY-0098 1350 μgAlso: ImotopeSmall synthetic peptide for SC admin. Solvent: alum hydroxide | Drug | IMCY-0098, high dose |
| PlaceboSolvent: alum hydroxide | Drug | Placebo |
Primary outcome
Change in stimulated C-peptide response during the first two hours of a mixed meal tolerance test (MMTT) from baseline to 48 weeks between IMCY-0098 and placebo groups
Time frame: From baseline to 48 weeks
The area under the stimulated C-peptide response curve over the first two hours of a MMTT
12 secondary outcomes
Changes in stimulated C-peptide response during the first two hours of a MMTT for the two doses of IMCY-0098 versus placebo
Time frame: From baseline to 24 months
Difference in Dried Blood Spots (DBS) fasted C-peptide between treatment and placebo groups
Time frame: From baseline to 48 weeks
Changes in DBS C-peptide measurements at each visit comparing each dose with placebo
Time frame: From baseline to 24 months
Effects of each dose of IMCY-0098 on HbA1c
Time frame: From baseline to 24 months
Effects of each dose of IMCY-0098 on hypoglycaemic events
Time frame: From baseline to 24 months
Effects of each dose of IMCY-0098 on diabetic ketoacidosis (DKA) episodes
Time frame: From baseline to 24 months
Effects of each dose of IMCY-0098 on daily total insulin dose
Time frame: From baseline to 24 months
Effects of each dose of IMCY-0098 on Continuous Glucose Monitoring (CGM) measures
Time frame: From baseline to 24 months
Impact of IMCY-0098 at each dose on autoantibodies against GAD65, IA 2, ZnT8 and insulin over time
Time frame: From baseline to 24 months
To evaluate the safety features of IMCY-0098 during treatment period
Time frame: Up to 7 days after the last dose
To evaluate the safety features of IMCY-0098 during the whole study duration
Time frame: Up to 48 weeks
To evaluate the safety features of IMCY-0098 on lymphocytes ratio
Time frame: Up to 48 weeks
Results and safety
The study was stopped early (reason given: No efficacy at primary analysis after 1 year. Long term follow-up stopped). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2024.
- 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.
Jean Van Rampelbergh study director
Imcyse SA
29 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing IMCY-0098 450 μg and IMCY-0098 1350 μg in people with Diabetes Mellitus, Type 1, run by Imcyse SA at 29 sites in 8 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 13 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 24 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in United Kingdom, United States, Australia, Belgium, Lithuania and 3 more countries. 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 was stopped early (reason given: No efficacy at primary analysis after 1 year. Long term follow-up stopped). 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?
Change in stimulated C-peptide response during the first two hours of a mixed meal tolerance test (MMTT) from baseline to 48 weeks between IMCY-0098 and placebo groups (time frame: From baseline to 48 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Jun 2024.