RECRUITING

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

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Conditions

Type 1 Diabetes MellitusT1DT1DMT1DM - Type 1 Diabetes MellitusType 1 Diabetes in AdolescenceType 1 Diabetes in ChildrenType 1 Diabetes (Juvenile Onset)Type 1 DiabetesType 1 Diabetes PatientsType 1 Diabetes MellitisDiabetesStage 3AdolescentsAdultsNewly DiagnosedRecently Diagnosed

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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 208-day study consists of a Screening Period (28 days), Treatment Period (90 days), and Post-Dose Evaluations (90 days).

Official Title

A Phase 1b/2a Double Blind, Placebo Controlled Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Efficacy of CNP-103 in Subjects Ages 12-35 With Recent Onset Stage 3 Type 1 Diabetes

Quick Facts

Study Start:2025-05-12
Study Completion:2027-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06783309

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:12 Years to 35 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * 1. Subjects who are willing and able to provide Institutional Review Board (IRB) approved written informed consent and privacy language as per national regulations.
  2. 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.
  3. 4. Subjects with a peak stimulated C-peptide of \>0.2 nmol/L measured from a mixed meal tolerance test (MMTT). Note: this test result may be obtained from an MMTT conducted within 1 month of planned first dose.
  4. 5. For subjects on any medication used to treat the symptoms of T1D (e.g., corticosteroids), subjects must be on a stable dose for a minimum of 1 month prior to enrollment and must agree not to increase their dose from Screening Visit through End of Study Visit unless reviewed and approved by the medical monitor and the site investigator
  1. * Subjects who have used the following medications:
  2. 2. Subjects who present with diabetic ketoacidosis (DKA) at the time of diagnosis. Note: any MMTT must be performed no sooner than 2 weeks and up to 4 weeks after DKA diagnosis.

Contacts and Locations

Study Contact

Dana Merritt
CONTACT
6023213267
Dmerritt@courpharma.com
Cristina Varela
CONTACT
9015172602
cvarela@courpharma.copm

Principal Investigator

Paul Peloso, MD
STUDY_DIRECTOR
COUR Pharma

Study Locations (Sites)

Diablo Clinical Research
Walnut Creek, California, 94598
United States
Barbara Davis Center for Childhood Diabetes
Aurora, Colorado, 80045
United States
DY Professional Research Center
Miami, Florida, 33176
United States
Barry J. Reiner, MD, LLC
Baltimore, Maryland, 21229
United States
MainStreet Health
Syosset, New York, 11566
United States
Wake Research
Raleigh, North Carolina, 27616
United States
Superior Clinical Research
Smithfield, North Carolina, 27277
United States
Texas Diabetes & Endocrinology
Austin, Texas, 78749
United States
M3 Wake Research - Dallas
Dallas, Texas, 75224
United States
Revival Research Institute
Denton, Texas, 76210
United States
Zillan Clinical Research
Houston, Texas, 77433
United States
Accurate Clinical Research, Inc
Humble, Texas, 77346
United States
Diabetes & Glandular Disease Clinic
San Antonio, Texas, 78229
United States

Collaborators and Investigators

Sponsor: COUR Pharmaceutical Development Company, Inc.

  • Paul Peloso, MD, STUDY_DIRECTOR, COUR Pharma

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-05-12
Study Completion Date2027-06

Study Record Updates

Study Start Date2025-05-12
Study Completion Date2027-06

Terms related to this study

Keywords Provided by Researchers

  • Diabetes
  • T1D
  • Stage 3
  • Adolescents
  • Adults
  • T1DM
  • Newly Diagnosed
  • Recently Diagnosed

Additional Relevant MeSH Terms

  • 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