Type 1 Diabetes MellitusPhase 1/2NCT06783309
CNP-103 in Adolescent and Adult Subjects Ages 12-35 With Recently Diagnosed (Within 6 Months) Stage 3 Type 1 Diabetes (T1D)
A Phase 1/2 study testing CNP-103 in people with Type 1 Diabetes Mellitus and T1D, run by COUR Pharmaceutical Development Company, Inc. at 45 sites in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 12 to 35 years
- Conditions the study is for
- Type 1 Diabetes Mellitus, T1D, T1DM
- What is being tested?
- CNP-103
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 45 sitesUnited States
- Study dates
- 12 May 2025to Jun 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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 12 to 35 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Participants who are willing and able to provide Institutional Review Board (IRB) approved written informed consent and privacy language as per national regulations.
- Men and non-pregnant, non-breast-feeding women ages 12-35 years inclusive.
- Documented diagnosis of Stage 3 T1D within 180 days prior to study enrollment according to American Diabetes Association (ADA) criteria.
- Participants must be on standard of care diabetes management including insulin therapy as a routine and also consisting of a nutrition plan, regular exercise, or other relevant specialty care as required on a patient-by-patient basis.
- Participants with a peak stimulated C-peptide of >0.2 nmol/L measured from a screening mixed meal tolerance test (MMTT).
- Participants with an episode of diabetic ketoacidosis (DKA) must have a MMTT performed no sooner than 2 weeks after resolution of the DKA event to have a qualifying C-peptide reading.
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- Participants on systemic corticosteroids or any medication used to treat the symptoms of T1D (other than insulin) must undergo a washout period of at least two weeks prior to enrollment and must agree to use a non-steroid alternative throughout the trial, if necessary, for any disorder requiring corticosteroids. In addition, participants must be on a stable dose of any other medications, other than insulin, for a minimum of 1 month prior to enrollment and must agree not to increase their dose from the Screening Visit through the End of Study Visit unless reviewed and approved by the medical monitor and the principal investigator.
- Female participants of non-childbearing potential (e.g., surgical sterilization, no menses for a year).
- Women of childbearing potential (WOCBP) who have agreed not to become pregnant during the study, have a negative pregnancy test at Screening Visit, and agree to use 1 highly effective form of birth control starting at initial screening and continuing throughout the entire study to Day 365.
- Female participants who agree to not breastfeed starting at initial Screening and throughout the entire study to Day 365.
- Female participants who agree to not donate ova, including autologous, starting at initial Screening and throughout the entire study to Day 365.
- Male participant and with a spouse or partner of childbearing potential, who themselves and their spouse or partner agree to practice an effective form of birth control as discussed with the study doctor or study staff starting at Screening and throughout the entire study to Day 365.
- Participants must weigh >35 kg at Screening for Cohort 1 (100 mg) and Cohort 2 (300 mg); participants must weigh >50 kg at Screening for Cohort 3 (600 mg).
- Body mass index (BMI):
- Participants 12-17 years: BMI Z-Score within 5th and 95th percentile based on participant's age (e.g., Baylor College of Medicine Age-based Pediatric Growth Reference Charts: BMI Z-Score and Percentile Calculator)
- Participants 18-35 years: 18.0-30.0 (not inclusive)
Who cannot join
- Participants unable to comply with prohibited medication outlined in the protocol.
- Exclusion of additional immunomodulation will be at the discretion of the Medical Monitor and study site Investigator.
- Participants with a history of tuberculosis or positive Quantiferon test.
- Participants who received vaccinations in the following time frame:
- Any live vaccine within 28 days prior to Screening.
- Any subunit vaccine within 14 days prior to Screening.
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- Any COVID-19 vaccine series within 14 days prior to Screening.
- Any other planned vaccine starting 14 days prior to Screening and through study Day 90 and 1 week after. (Note: The annual influenza vaccine is not an exclusion criterion.)
- Known or suspected acute infection, including COVID-19 at the time of Screening or within 2 weeks prior to Screening. After confirmed recent COVID-19 infection, a minimum of 2 weeks of recovery post-acute infection is required.
- Participants with Screening laboratory test results that are outside the normal limits and considered by the Investigator to be clinically significant.
- Participants with positive test results for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, or human immunodeficiency virus (HIV) antigen/antibody as determined at Screening.
- Participants with a history of or currently active immune disorders other than T1D (including autoimmune disease) unless the condition, after discussion with the Medical Monitor, has been deemed to be acceptable for the participant's participation in this study.
- Participants with a clinical history of significant cardiovascular disease in the past 12 months.
- Participants with a complication or medical history of malignant tumor, other than basal cell or squamous cell carcinomas of the skin.
- Participants who, in the Investigator's opinion, will be unable to adhere to study visits and procedures.
- Participants who have received investigational therapy other than CNP-103 within 28 days or 5 half-lives, whichever is longer, prior to Screening.
- Participants with any known active condition which, in the Investigator's opinion, makes the participant unsuitable for study participation.
- Known sensitivity to any components of CNP-103.
Trial locations and contacts
45 sites in 1 country. Contact the study team or a site near you to ask about taking part.
45 sites in 1 country
United States45 sites, 45 recruiting
- Recruiting
University of Michigan
Ann Arbor, Michigan, 48109
Adam Neidert, 734-615-0539, aneidert@med.umich.edu
Carman Richison, 734-615-6258, caaguiar@med.umich.edu
- Recruiting
Atlanta Diabetes Association
Atlanta, Georgia, 30318
Amanda Maxson, 404-355-4393, amaxson@atlantadiabetes.com
Carson Womack
- Recruiting
Emory University
Atlanta, Georgia, 30322
Meaza Girmay, 404-778-6382, meaza.girmay@emory.edu
Michael Hughes
- Recruiting
Children's Healthcare of Atlanta
Atlanta, Georgia, 30329
Jordyn Turner, 404-785-3690, Jordyn.Turner@choa.org
Kristina Cossen
- Recruiting
Barbara Davis Center for Childhood Diabetes
Aurora, Colorado, 80045
Hali Broncucia, 3037247526, hali.broncucia@cuanschutz.edu
Fatima Tensun, fatima.tensun@cuanschutz.edu
- Recruiting
Texas Diabetes & Endocrinology
Austin, Texas, 78749
Emmanuel Lopez, 5123343505, elopez@texasdiabetes.com
Olivia Johnson, ojohnson@texasdiabetes.com
- Recruiting
Barry J. Reiner, MD, LLC
Baltimore, Maryland, 21229
Lee Bromberger, 410-646-4009, reinerstudy.lee@gmail.com
Ashley Hargrove, reinerstudy.ashley2@gmail.com
- Recruiting
Embassy Research Network
Bloomfield Township, Michigan, 48302
Zander Minano, 248-622-4083, zminano@embassyresearch.com
George Grunberger
- Recruiting
Joslin Diabetes Center
Boston, Massachusetts, 02215
Abigail Coryell, 617-309-1909, acoryell@joslin.harvard.edu
Jason Gaglia
- Recruiting
UBMD Pediatrics - University of Buffalo
Buffalo, New York, 14203
Amanda House, 716-323-0075, ahouse@upa.chob.edu
Lucy Mastrandrea
- Recruiting
University Diabetes & Endocrine Consultants
Chattanooga, Tennessee, 37411
Gina Harris, 423-265-3561, gharris@drhuffman.com
David Huffman
- Recruiting
Ann & Robert H. Lurie Children's Hospital
Chicago, Illinois, 60611
Rohin Sagar, 312-227-9403, rsagar@luriechildrens.org
Maddie Lamphear, 312-227-9403, mlamphear@luriechildrens.org
- Recruiting
Northwestern University
Chicago, Illinois, 60611
Stefanie Hermann, 312-926-8693, s-herrmann@northwestern.edu
Evelyn Fronczyk, evelyn.guevara@northwestern.edu
- Recruiting
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
Quiana Howard, 216-286-0021, Quiana.Howard@UHhospitals.org
Jennie Phan, 216-286-7454, Jennie.Phan@Uhhospitals.org
- Recruiting
M3 Wake Research - Dallas
Dallas, Texas, 75246
Vicki Martinez, 469-297-3074, vmartinez@wakeresearch.com
Carlos Arauz-Pacheco
- Recruiting
Duke University
Durham, North Carolina, 27710
Kia Gaskins, 919-613-0234, kiah.gaskin@duke.edu
Jennifer Green
- Recruiting
Southwest General Healthcare Center
Fort Myers, Florida, 33907
Daniela Pargas, 239-931-3368, daniela@swghealthcare.com
Sandra Perez, 239-931-3368, sandra@swghealthcare.com
- Recruiting
University of Florida
Gainesville, Florida, 32610
Magali Jorand-Fletcher, 352-294-5760, magali20@ufl.edu
Sarah Peeling, 352-273-5275, smpeeling@peds.ufl.edu
- Recruiting
Physicians East, PA
Greenville, North Carolina, 27834
Kirsten Goff, 252-413-6299, ktaylor@physicianseast.com
Mark Warren
- Recruiting
Evolution Research Center
Hialeah, Florida, 33012
Ana Fernandez, 786-708-6008, afernandez@evolutionresearchcenter.com
Jany Fundora, jfundora@evolutionresearchcenter.com
- Recruiting
Accurate Clinical Research, Inc
Humble, Texas, 77346
Valerie Blanco, 2817603930, vblanco@accurateclinicalresearch.com
Soamy Rivera, srivera@accurateclinicalresearch.com
- Recruiting
Rocky Mountain Diabetes and Osteoporosis Center
Idaho Falls, Idaho, 83404
Ben Houston, 208-525-3739, ben.houston@rmclinicalresearch.com
Joann Malone, 208-528-9650, joann.malone@rmclinicalresearch.com
- Recruiting
Riley Hospital for Children- Indiana University
Indianapolis, Indiana, 46202
Nate De Jong, 317-278-4874, nadejong@iu.edu
Linda DeMeglio
- Recruiting
Nemours Children's Health
Jacksonville, Florida, 32207
Jennifer Pann, 904-776-2810, jennifer.pann@nemours.org
Larry Fox
- Recruiting
Children's Mercy Hospital
Kansas City, Missouri, 64108
Ashley Parks, 816-302-8419, anparks@cmh.edu
Wayne Moore
- Recruiting
Le Bonhuer Children's
Memphis, Tennessee, 38105
Christine Watkins, 901-287-5579, christine.watkins@lebonheur.org
Ramin Alemzadeh
- Recruiting
University of Miami
Miami, Florida, 33136
Danay Saavedra, 305-243-6616, dxs4415@med.miami.edu
Jhanvi Doshi, 305-243-3306, jxd4468@med.miami.edu
- Recruiting
DY Professional Research Center
Miami, Florida, 33176
Yesenia Escarpio, 3059828331, yescarpio@dymedicalresearch.com
Soroush Aghigh
- Recruiting
University of Minnesota
Minneapolis, Minnesota, 55454
Veronica Jones-Carr, 612-625-9709, jone2678@umn.edu
Kali Johnson, joh13933@umn.edu
- Recruiting
Hassenfield Children's Hospital
New York, New York, 10016
Jeniece Ilkowitz, 212-263-9910, jeniece.ilkowitz@nyulangone.org
Mary Gallagher
- Recruiting
NYU Langone Diabetes & Endocrine Associates
New York, New York, 10017
Amanda Baly, 212-637-7000, Amanda.Baly@nyulangone.org
Ramachandra Naik
- Recruiting
Hoag Memorial Hospital
Newport Beach, California, 92663
Brittany Dennis, 949-764-6896, brittany.dennis@hoag.org
Cadence Cooper, 949-764-6896, cadence.cooper@hoag.org
- Recruiting
Wake Research - Raleigh
Raleigh, North Carolina, 27612
LaTosha Gonzalez, 9192142514, lgonzalez@wakeresearch.com
Fabricio Nunez, fnunez@wakeresearch.com
- Recruiting
Diabetes & Glandular Disease (DGD) Clinic, P.A.
San Antonio, Texas, 78229
Bobbi Hernandez, 2106148612 ext. 1088, bobbi.hernandez@dgdclinic.com
Monique Johnson, monique.johnson@dgdclinic.com
- Recruiting
Rady Children's Hospital San Diego
San Diego, California, 92123
Carla Logan, 858-966-8400, clogan1@rchsd.org
Angela Lam, 858-966-8400, alam@rchsd.org
- Recruiting
Benaroya Research Institute
Seattle, Washington, 98101
Erica Bourget, 206-341-8997, EBourget@benaroyaresearch.org
Natalie Clary, 206-342-6963, nclary@benaroyaresearch.org
- Recruiting
University of Washington Diabetes Institute
Seattle, Washington, 98109
Dori Khakpour, 206-945-4965, dorik@uw.edu
Irl Hirsch
- Recruiting
Superior Clinical Research
Smithfield, North Carolina, 27577
Briana White, 9199388058, briana@superiorclinicalresearch.com
Martha Dockery, martha@superiorclinicalresearch.com
- Recruiting
Southern Illinois University School of Medicine
Springfield, Illinois, 62702
Rebecca Owens, 217-545-7321, rowens29@siumed.edu
Katharine Blancett, 217-545-7799, kblancett37@siumed.edu
- Recruiting
Washington University School of Medicine
St Louis, Missouri, 63110
Elizabeth Sellitto, 314-362-6821, esellitto@wustl.edu
Janet McGill
- Recruiting
University of South Florida
Tampa, Florida, 33612
Elizabeth Dunn, 813-974-4886, eadunn3@usf.edu
Henry Rodriguez
- Recruiting
Wake Research - Tucson
Tucson, Arizona, 85710
Namrata Oza, 520-210-7930, noza@wakeresearch.com
David Alster
- Recruiting
Liver Institute PLLC
Tucson, Arizona, 85716
Nicolette Brown, 520-209-1757, nbrown@liverinstitutepllc.org
Neda Ebrahimi
- Recruiting
Diablo Clinical Research
Walnut Creek, California, 94598
Drew Jaffe, 9259307287, djaffe@diabloclinical.com
Catherine Morimoto, cmorimoto@diabloclinical.com
- Recruiting
TopLine Clinical, Inc
Waxahachie, Texas, 75165
Lacey Powers, 972-965-3247, lacey@toplineclinical.com
Stephen Mueller
About this study
Official title: A Phase 1b/2a Double Blind, Placebo Controlled Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Efficacy of CNP-103 in Participants Ages 12-35 With Recent Onset Stage 3 Type 1 Diabetes
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).
- Conditions
- Type 1 Diabetes Mellitus, T1D, T1DM, T1DM - Type 1 Diabetes Mellitus, Type 1 Diabetes in Adolescence, Type 1 Diabetes in Children
- Being tested
- CNP-103, Placebo
- Keywords
- Diabetes, T1D, Stage 3, Adolescents, Adults, T1DM, Newly Diagnosed, Recently Diagnosed
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CNP-103Drug
Also called Treatment
CNP-103
PlaceboDrug
0.9% sodium chloride for injection
| Study group | Role | What they receive |
|---|---|---|
| Adult Cohort 1 (100 mg CNP-103) | Experimental | Three (3) IV administrations of CNP-103 (100 mg) on Days 1, 8, and 90 Receives: Drug: CNP-103; Drug: Placebo |
| Adult Cohort 2 (300 mg CNP-103) | Experimental | Three (3) IV administrations of CNP-103 (300 mg) on Days 1, 8, and 90 Receives: Drug: CNP-103; Drug: Placebo |
| Adult Cohort 3 (600 mg CNP-103) | Experimental | Three (3) IV administrations of CNP-103 (600 mg) on Days 1, 8, and 90 Receives: Drug: CNP-103; Drug: Placebo |
| Adolescent Cohort 1 (100 mg CNP-103) | Experimental | Three (3) IV administrations of CNP-103 (100 mg) on Days 1, 8, and 90 Receives: Drug: CNP-103; Drug: Placebo |
| Adolescent Cohort 2 (300 mg CNP-103) | Experimental | Three (3) IV administrations of CNP-103 (300 mg) on Days 1, 8, and 90 Receives: Drug: CNP-103; Drug: Placebo |
| Adolescent Cohort 3 (600 mg CNP-103) | Experimental | Three (3) IV administrations of CNP-103 (600 mg) on Days 1, 8, and 90 Receives: Drug: CNP-103; Drug: Placebo |
| Expansion Cohort | Experimental | Dosing for the Expansion Cohort will be determined from Escalation Phase results Receives: Drug: CNP-103; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
Frequency of Adverse Events (AEs) and Serious Adverse Events (SAEs), MedDRA 28.1 (CTCAE v. 5.0) or current
Measured: Day 1 Through Day 365
Immune Safety
Serum Cytokines: IL-1β, TNF-α, IL-6, MCP-1, MIP-1α, IFN-γ, IL-4, IL-10
Measured: Day 1 Through Day 365
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2025
- Study start12 May 2025
- Primary completionDec 2026 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes MellitusStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study will enroll up to three cohorts across two age groups, adults (18-35 years) and adolescents (12-17 years), with six subjects per cohort (approximately 18 subjects per age group, 36 subjects total) at multiple ascending dose levels during the Escalation Phase. Enrollment of each adolescent cohort will be staggered, beginning only after the corresponding adult cohort has completed the Day 15 visit and undergone DMC review. Subjects will be randomized 2:1 to receive either CNP-103 or placebo (0.9% Sodium Chloride Injection, USP) as a 200 mL intravenous infusion on Day 1, Day 8, and Day 90. The Expansion Phase will follow, enrolling approximately 36 subjects at the safe and tolerated dose(s) identified during the Escalation Phase. Subjects in this phase will be randomized 3:1 to receive either CNP-103 or placebo (0.9% Sodium Chloride Injection, USP).
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- COUR Pharmaceutical Development Company, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Paul Peloso, MD, Study director, COUR Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06783309
- Sponsor's protocol ID
- CNP-103-CL-201
- Status last verified
- Mar 2026
- First submitted
- 14 Jan 2025
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b/2a Double Blind, Placebo Controlled Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Efficacy of CNP-103 in Participants Ages 12-35 With Recent Onset Stage 3 Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT06783309
- Acronym / sponsor ID
- CNP-103-CL-201
- Conditions
- Type 1 Diabetes Mellitus, T1D, T1DM, T1DM - Type 1 Diabetes Mellitus, Type 1 Diabetes in Adolescence, Type 1 Diabetes in Children
- Keywords
- Diabetes, T1D, Stage 3, Adolescents, Adults, T1DM, Newly Diagnosed, Recently Diagnosed
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- COUR Pharmaceutical Development Company, Inc.Industry (pharma, biotech, devices)
- Study start
- 12 May 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 20 Jan 2025 (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.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 7
- Model description
- The study will enroll up to three cohorts across two age groups, adults (18-35 years) and adolescents (12-17 years), with six subjects per cohort (approximately 18 subjects per age group, 36 subjects total) at multiple ascending dose levels during the Escalation Phase. Enrollment of each adolescent cohort will be staggered, beginning only after the corresponding adult cohort has completed the Day 15 visit and undergone DMC review. Subjects will be randomized 2:1 to receive either CNP-103 or placebo (0.9% Sodium Chloride Injection, USP) as a 200 mL intravenous infusion on Day 1, Day 8, and Day 90. The Expansion Phase will follow, enrolling approximately 36 subjects at the safe and tolerated dose(s) identified during the Escalation Phase. Subjects in this phase will be randomized 3:1 to receive either CNP-103 or placebo (0.9% Sodium Chloride Injection, USP).
| Arm | Type | Receives |
|---|---|---|
| Adult Cohort 1 (100 mg CNP-103) | Experimental | Drug: CNP-103, Drug: PlaceboThree (3) IV administrations of CNP-103 (100 mg) on Days 1, 8, and 90 |
| Adult Cohort 2 (300 mg CNP-103) | Experimental | Drug: CNP-103, Drug: PlaceboThree (3) IV administrations of CNP-103 (300 mg) on Days 1, 8, and 90 |
| Adult Cohort 3 (600 mg CNP-103) | Experimental | Drug: CNP-103, Drug: PlaceboThree (3) IV administrations of CNP-103 (600 mg) on Days 1, 8, and 90 |
| Adolescent Cohort 1 (100 mg CNP-103) | Experimental | Drug: CNP-103, Drug: PlaceboThree (3) IV administrations of CNP-103 (100 mg) on Days 1, 8, and 90 |
| Adolescent Cohort 2 (300 mg CNP-103) | Experimental | Drug: CNP-103, Drug: PlaceboThree (3) IV administrations of CNP-103 (300 mg) on Days 1, 8, and 90 |
| Adolescent Cohort 3 (600 mg CNP-103) | Experimental | Drug: CNP-103, Drug: PlaceboThree (3) IV administrations of CNP-103 (600 mg) on Days 1, 8, and 90 |
| Expansion Cohort | Experimental | Drug: CNP-103, Drug: PlaceboDosing for the Expansion Cohort will be determined from Escalation Phase results |
Who may qualify
- Ages
- 12 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (16 listed)
- Participants who are willing and able to provide Institutional Review Board (IRB) approved written informed consent and privacy language as per national regulations.
- Men and non-pregnant, non-breast-feeding women ages 12-35 years inclusive.
- Documented diagnosis of Stage 3 T1D within 180 days prior to study enrollment according to American Diabetes Association (ADA) criteria.
- Participants must be on standard of care diabetes management including insulin therapy as a routine and also consisting of a nutrition plan, regular exercise, or other relevant specialty care as required on a patient-by-patient basis.
- Participants with a peak stimulated C-peptide of >0.2 nmol/L measured from a screening mixed meal tolerance test (MMTT).
Key exclusion criteria (18 listed)
- Participants unable to comply with prohibited medication outlined in the protocol.
- Exclusion of additional immunomodulation will be at the discretion of the Medical Monitor and study site Investigator.
- Participants with a history of tuberculosis or positive Quantiferon test.
- Participants who received vaccinations in the following time frame:
- Known or suspected acute infection, including COVID-19 at the time of Screening or within 2 weeks prior to Screening. After confirmed recent COVID-19 infection, a minimum of 2 weeks of recovery post-acute infection is required.
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 |
|---|---|---|
| CNP-103Also: TreatmentCNP-103 | Drug | Adolescent Cohort 1 (100 mg CNP-103), Adolescent Cohort 2 (300 mg CNP-103), Adolescent Cohort 3 (600 mg CNP-103), Adult Cohort 1 (100 mg CNP-103), Adult Cohort 2 (300 mg CNP-103), Adult Cohort 3 (600 mg CNP-103), Expansion Cohort |
| Placebo0.9% sodium chloride for injection | Drug | Adolescent Cohort 1 (100 mg CNP-103), Adolescent Cohort 2 (300 mg CNP-103), Adolescent Cohort 3 (600 mg CNP-103), Adult Cohort 1 (100 mg CNP-103), Adult Cohort 2 (300 mg CNP-103), Adult Cohort 3 (600 mg CNP-103), Expansion Cohort |
Primary outcome
Safety
Time frame: Day 1 Through Day 365
Frequency of Adverse Events (AEs) and Serious Adverse Events (SAEs), MedDRA 28.1 (CTCAE v. 5.0) or current
Immune Safety
Time frame: Day 1 Through Day 365
Serum Cytokines: IL-1β, TNF-α, IL-6, MCP-1, MIP-1α, IFN-γ, IL-4, IL-10
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
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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.
Paul Peloso, MD study director
COUR Pharma
45 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing CNP-103 in people with Type 1 Diabetes Mellitus and T1D, run by COUR Pharmaceutical Development Company, Inc. at 45 sites in United States.
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 16 inclusion and 18 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: looking for participants now, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 45 sites in United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stephanie Slaughter (317-727-2551, sslaughter@courpharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety (time frame: Day 1 Through Day 365). The study lists 2 primary outcomes in all. 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 11 Sep 2026.