CNP-103 for Recently Diagnosed Stage 3 Type 1 Diabetes

CNP-103 in Adolescent and Adult Subjects Ages 12-35 With Recently Diagnosed (Within 6 Months) Stage 3 Type 1 Diabetes (T1D)

Recruiting Phase 1 Phase 2 Interventional Study
Type 1 Diabetes Mellitus T1D T1DM T1DM - Type 1 Diabetes Mellitus Type 1 Diabetes in Adolescence Type 1 Diabetes in Children Type 1 Diabetes (Juvenile Onset) Type 1 Diabetes Type 1 Diabetes Patients Type 1 Diabetes Mellitis
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
12 – 35
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
72 (estimated)
Sponsor
COUR Pharmaceutical Development Company, Inc. · Industry
Who this trial is looking for

This trial is looking for teenagers and young adults aged 12-35 who have been diagnosed with Type 1 Diabetes in the last 6 months. Participants will take a study medication called CNP-103 and will be monitored for safety and effectiveness over about a year.

Are You a Good Fit for This Trial?
Must be taking Insulin

You may be able to join if

  • I am between 12 and 35 years old.
  • I have been diagnosed with Stage 3 Type 1 Diabetes in the last 6 months.
  • I weigh more than 35 kg (or 50 kg for a higher dose).
  • I am following a diabetes management plan that includes insulin.
  • I am willing to follow study rules and attend all appointments.
  • I can provide consent if I’m over 18, or have a parent or guardian who can consent for me if I’m under 18.
  • I have a negative pregnancy test and will use birth control if I am a female of childbearing potential.
  • I agree not to breastfeed during the study.

You may not be able to join if

  • I cannot follow the medication guidelines in the study.
  • I have had tuberculosis or a positive test for it.
  • I received any live vaccine in the last 28 days.
  • I have had a significant cardiovascular issue in the past year.
  • I have active immune disorders other than Type 1 Diabetes.
  • I have tested positive for HIV, hepatitis B, or hepatitis C.
  • I have had a serious infection, including COVID-19, in the last 2 weeks.
  • I have a history of significant cancer other than non-melanoma skin cancers.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial

This study is a Phase 1b/2a First-in-Human (FIH) clinical trial to assess the safety, tolerability, pharmacodynamics (PD), and efficacy of multiple ascending doses of CNP-103. The approximately 393-days study consists of a Screening Period (28 days), Treatment Period (90 days), and Post-Dose Evaluations (275 days).

Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Participants who are willing and able to provide Institutional Review Board (IRB) approved written informed consent and privacy language as per national regulations. 2. Men and non-pregnant, non-breast-feeding women ages 12-35 years inclusive. 3. Documented diagnosis of Stage…
Contacts

Stephanie Slaughter

317-727-2551

sslaughter@courpharma.com

CONTACT

Cristina Varela

901-517-2602

cvarela@courpharma.copm

CONTACT