CNP-103 for Type 1 Diabetes

Recruiting at 31 trial locations

Overseen By Emily Hong

Age: < 65

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: COUR Pharmaceutical Development Company, Inc.

Must be taking: Insulin

Must not be taking: Oral immunomodulators, B cell immunotherapy

Disqualifiers: Diabetic ketoacidosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 13 weeks

72 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called CNP-103 for individuals with Type 1 Diabetes (T1D). The goal is to assess the safety and effectiveness of different doses of CNP-103 in managing T1D. Participants will receive the treatment through three intravenous (IV) doses on specific days over a 90-day period. The trial seeks individuals diagnosed with T1D in the past six months who currently manage their condition with insulin and lifestyle changes like diet and exercise. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

You may need to stop taking certain medications. If you're on systemic corticosteroids, you'll need a two-week break before joining the trial and switch to a non-steroid option if needed. Also, you must be on a stable dose of any other medications, except insulin, for at least a month before starting the trial.

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

Research shows that CNP-103 remains in the early testing stages, so information about its safety in humans is limited. This Phase 1b/2a trial primarily aims to assess the treatment's safety and tolerability.

Before human testing, CNP-103 was studied in labs, where it showed potential in aiding the immune system with Type 1 Diabetes. This suggests possible safety, but confirmation in humans is necessary.

As this marks the first human testing of CNP-103, the study closely monitors for side effects or unexpected issues. Different groups in the trial receive varying doses to evaluate how well participants tolerate the treatment at different levels.

Although specific safety data for CNP-103 in humans is not yet available, the trial phase indicates that the treatment has passed initial safety checks and is now under close study in a controlled environment. Participants will be monitored closely to manage any side effects. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for Type 1 Diabetes?

Most treatments for Type 1 Diabetes focus on managing blood sugar levels through insulin therapy and lifestyle changes. But CNP-103 stands out because it introduces a potentially groundbreaking approach by being administered via three intravenous infusions. Researchers are particularly excited about CNP-103 because it might offer a novel way to modulate the immune system, potentially addressing the root cause of the autoimmune attack that characterizes Type 1 Diabetes, rather than just managing symptoms. This could lead to longer-term benefits and reduce the burden of daily management for patients.

What evidence suggests that CNP-103 might be an effective treatment for Type 1 Diabetes?

Research has shown that CNP-103 could be helpful in treating Type 1 Diabetes. In early studies with mice, CNP-103 significantly slowed the disease. It uses tiny particles to retrain the immune system, reducing its attack on insulin-producing cells. This might help the body continue producing insulin independently. While these findings are encouraging, they are based on animal studies, and human testing is necessary to confirm effectiveness. This trial will evaluate different dosages of CNP-103 in both adult and adolescent cohorts to determine its safety and efficacy in humans. ^{2 4 6 7 8}

Who Is on the Research Team?

Paul Peloso, MD

Principal Investigator

COUR Pharma

Are You a Good Fit for This Trial?

This trial is for young people and adults aged 12-35 who've been diagnosed with Stage 3 Type 1 Diabetes within the last 6 months. Participants must be able to consent, not pregnant or breastfeeding, and have a certain level of C-peptide from a recent test.

Inclusion Criteria

I am willing to sign the consent form approved by the review board.

2. Men and non-pregnant, non-breast-feeding women ages 12-35 years inclusive. 3. Documented diagnosis of T1D within 180 days prior to study enrollment according to American Diabetes Association \[ADA\] criteria.

My C-peptide level was above 0.2 nmol/L after a meal test.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

Treatment

Participants receive multiple ascending doses of CNP-103 over 90 days

13 weeks

3 visits (in-person) on Days 1, 8, and 90

Post-Dose Evaluations

Participants are monitored for safety, tolerability, and pharmacodynamics after treatment

13 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• CNP-103

Trial Overview The study tests CNP-103 against a placebo to see if it's safe and works for treating Type 1 Diabetes. It includes initial screening, a treatment period of three months, and follow-up evaluations lasting another three months.

How Is the Trial Designed?

Group I: Expansion Cohort Experimental Treatment 2 Interventions

Dosing for the Expansion Cohort will be determined from Escalation Phase results

Group II: Adult Cohort 3 (600 mg CNP-103) Experimental Treatment 2 Interventions

Three (3) IV administrations of CNP-103 (600 mg) on Days 1, 8, and 90

Group III: Adult Cohort 2 (300 mg CNP-103) Experimental Treatment 2 Interventions

Three (3) IV administrations of CNP-103 (300 mg) on Days 1, 8, and 90

Group IV: Adult Cohort 1 (100 mg CNP-103) Experimental Treatment 2 Interventions

Three (3) IV administrations of CNP-103 (100 mg) on Days 1, 8, and 90

Group V: Adolescent Cohort 3 (600 mg CNP-103) Experimental Treatment 2 Interventions

Three (3) IV administrations of CNP-103 (600 mg) on Days 1, 8, and 90

Group VI: Adolescent Cohort 2 (300 mg CNP-103) Experimental Treatment 2 Interventions

Three (3) IV administrations of CNP-103 (300 mg) on Days 1, 8, and 90

Group VII: Adolescent Cohort 1 (100 mg CNP-103) Experimental Treatment 2 Interventions

Three (3) IV administrations of CNP-103 (100 mg) on Days 1, 8, and 90

Who Is Running the Clinical Trial?

COUR Pharmaceutical Development Company, Inc.

Lead Sponsor

Trials

7

Recruited

250+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06783309

CNP-103 in Adolescent and Adult Subjects Ages 12-35 ... This study is a Phase 1b/2a First-in-Human (FIH) clinical trial to assess the safety, tolerability, pharmacodynamics (PD), and efficacy of multiple ...

2. courpharma.com courpharma.com/patients/cnp-103-clinical-trial-in-type-1-diabetes/

CNP-103 Clinical Trial in Type 1 Diabetes The purpose of this study is to assess the safety, tolerability, pharmacodynamics (PD), and efficacy of multiple ascending doses of CNP-103, an investigational ...

3. clinicaltrialvanguard.com clinicaltrialvanguard.com/news/cour-pharma-doses-first-patient-in-cnp-103-trial-for-type-1-diabetes/

Cour Pharma Doses First Patient in CNP-103 Trial for Type ... The trial will evaluate CNP-103 in newly diagnosed stage 3 T1D patients aged 12-35 with C-peptide levels above 0.2 nmol/L. This trial initiation ...

4. managedhealthcareexecutive.com managedhealthcareexecutive.com/view/nanoparticle-therapy-has-potential-to-reprogram-the-immune-system-in-type-1-diabetes

Nanoparticle Therapy has Potential to Reprogram the ... “In preclinical studies to date, CNP-103 has demonstrated the ability to stop T1D disease progression while creating an enhanced pro-regulatory ...

5. drugtargetreview.com drugtargetreview.com/article/149607/treating-immune-mediated-diseases-with-nanoparticles/

Treating immune-mediated diseases with nanoparticles In preclinical studies to date, treatment with CNP-103 in the NOD mouse model of diabetes has shown the ability to significantly increase the ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06783309

CNP-103 in Adolescent and Adult Subjects Ages 12-35 ... This study is a Phase 1b/2a First-in-Human (FIH) clinical trial to assess the safety, tolerability, pharmacodynamics (PD), and efficacy of multiple ...

7. firstwordpharma.com firstwordpharma.com/story/5990370

COUR Pharma Doses First Patient in Clinical Trial ... “While CNP-103 has potential across stages 1 through 3 in T1D and potentially in later-stage patients in combination with islet cell transplants ...

8. connect.careboxhealth.com connect.careboxhealth.com/en-US/trial/listing/568039

CNP-103 in Adolescent and Adult Subjects Ages 12-35 With ... This study is a Phase 1b/2a First-in-Human (FIH) clinical trial to assess the safety, tolerability, pharmacodynamics (PD), and efficacy of multiple ...