CNP-103 in Adolescent and Adult Subjects Ages 12-35 With Recently Diagnosed (Within 6 Months) Stage 3 Type 1 Diabetes (T1D)
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
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 12 Years to 35 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests CNP-103 in people ages 12–35 who were diagnosed with stage 3 type 1 diabetes within the past 6 months. It is the first study of this drug in humans and tests several increasing doses to learn about its safety, side effects, and how well it works. The study lasts about 393 days.
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).
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be ages 12–35, with a documented diagnosis of stage 3 type 1 diabetes within 180 days before joining.
- Be willing and able to give written consent and agree to the study's privacy rules.
- Receive usual diabetes care, including regular insulin treatment, a food plan, and exercise or other care as needed.
- Have a C-peptide level above 0.2 nmol/L on a meal test, showing that your body still makes insulin. After diabetic ketoacidosis, a serious acid buildup in the blood, wait at least 2 weeks after recovery before this test.
- Stop whole-body steroid medicines and diabetes medicines other than insulin at least 2 weeks before joining. Use non-steroid options if needed. Other medicine doses must be stable for at least 1 month, with later increases approved by study doctors.
- Not be pregnant or breastfeeding. Women who can become pregnant must have a negative pregnancy test and use highly effective birth control through Day 365. Men with partners who can become pregnant must follow birth control rules. Women must not breastfeed or donate eggs through Day 365.
- Weigh more than 35 kg for the 100 mg or 300 mg dose groups, or more than 50 kg for the 600 mg group.
- Meet body mass index (BMI), a measure of weight compared with height, limits: ages 12–17 must be within the 5th–95th percentile for age; adults must have a BMI above 18 and below 30.
Who can't join
- Cannot follow medicine limits, study visits, or procedures; or have another active condition that the study doctor thinks makes joining unsuitable. Other treatments that change the immune system need study doctor review.
- Have a history of tuberculosis, a positive tuberculosis blood test, or a positive screening test for hepatitis B, hepatitis C, or HIV.
- Have a known or suspected recent infection, including COVID-19, at screening or in the 2 weeks before it. After COVID-19, at least 2 weeks of recovery is required.
- Received a live vaccine within 28 days before screening, or a subunit vaccine (made from pieces of a germ) or COVID-19 vaccine series within 14 days. Other planned vaccines from 14 days before screening through Day 97 are restricted; the yearly flu vaccine is allowed.
- Have important abnormal screening test results, or an immune system disorder other than type 1 diabetes, unless study doctors approve that disorder.
- Have had serious heart or blood vessel disease in the past 12 months, or have a cancer history other than basal cell or squamous cell skin cancer.
- Received another study treatment within 28 days before screening, or longer if that treatment takes more time to leave the body.
- Have a known sensitivity to any part of CNP-103.
Simplified for readability. The official criteria below are what the study team uses.
Official 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 3 T1D within 180 days prior to study enrollment according to American Diabetes Association (ADA) criteria. 4. 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. 5. Participants with a peak stimulated C-peptide of \>0.2 nmol/L measured from a screening mixed meal tolerance test (MMTT). 6. 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. 7. 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. 8. Female participants of non-childbearing potential (e.g., surgical sterilization, no menses for a year). 9. 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. 10. Female participants who agree to not breastfeed starting at initial Screening and throughout the entire study to Day 365. 11. Female participants who agree to not donate ova, including autologous, starting at initial Screening and throughout the entire study to Day 365. 12. 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. 13. 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). 14. Body mass index (BMI): 1. 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) 2. Participants 18-35 years: 18.0-30.0 (not inclusive) Exclusion Criteria: 1. Participants unable to comply with prohibited medication outlined in the protocol. 2. Exclusion of additional immunomodulation will be at the discretion of the Medical Monitor and study site Investigator. 3. Participants with a history of tuberculosis or positive Quantiferon test. 4. Participants who received vaccinations in the following time frame: 1. Any live vaccine within 28 days prior to Screening. 2. Any subunit vaccine within 14 days prior to Screening. 3. Any COVID-19 vaccine series within 14 days prior to Screening. 4. 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.) 5. 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. 6. Participants with Screening laboratory test results that are outside the normal limits and considered by the Investigator to be clinically significant. 7. 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. 8. 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. 9. Participants with a clinical history of significant cardiovascular disease in the past 12 months. 10. Participants with a complication or medical history of malignant tumor, other than basal cell or squamous cell carcinomas of the skin. 11. Participants who, in the Investigator's opinion, will be unable to adhere to study visits and procedures. 12. Participants who have received investigational therapy other than CNP-103 within 28 days or 5 half-lives, whichever is longer, prior to Screening. 13. Participants with any known active condition which, in the Investigator's opinion, makes the participant unsuitable for study participation. 14. Known sensitivity to any components of CNP-103.
Study sites (45)
AZ
- Wake Research - Tucson · Tucson, AZ 85710Namrata Oza · Study contact · 520-210-7930 · noza@wakeresearch.comDavid Alster · Principal investigatorMore trials in Tucson
- Liver Institute PLLC · Tucson, AZ 85716Nicolette Brown · Study contact · 520-209-1757 · nbrown@liverinstitutepllc.orgNeda Ebrahimi · Principal investigatorMore trials in Tucson
CA
- Hoag Memorial Hospital · Newport Beach, CA 92663Brittany Dennis · Study contact · 949-764-6896 · brittany.dennis@hoag.orgCadence Cooper · Study contact · 949-764-6896 · cadence.cooper@hoag.orgDavid Ahn · Principal investigatorMore trials in Newport Beach
- Rady Children's Hospital San Diego · San Diego, CA 92123Carla Logan · Study contact · 858-966-8400 · clogan1@rchsd.orgAngela Lam · Study contact · 858-966-8400 · alam@rchsd.orgCarla Demeterco-Berggren · Principal investigatorMore trials in San Diego
- Diablo Clinical Research · Walnut Creek, CA 94598Drew Jaffe · Study contact · 9259307287 · djaffe@diabloclinical.comCatherine Morimoto · Study contact · cmorimoto@diabloclinical.comMark Christiansen · Principal investigatorMore trials in Walnut Creek
CO
- Barbara Davis Center for Childhood Diabetes · Aurora, CO 80045Hali Broncucia · Study contact · 3037247526 · hali.broncucia@cuanschutz.eduFatima Tensun · Study contact · fatima.tensun@cuanschutz.eduTaylor Triolo · Principal investigatorMore trials in Aurora
FL
- Southwest General Healthcare Center · Fort Myers, FL 33907Daniela Pargas · Study contact · 239-931-3368 · daniela@swghealthcare.comSandra Perez · Study contact · 239-931-3368 · sandra@swghealthcare.comOrlando Fernandez · Principal investigatorMore trials in Fort Myers
- University of Florida · Gainesville, FL 32610Magali Jorand-Fletcher · Study contact · 352-294-5760 · magali20@ufl.eduSarah Peeling · Study contact · 352-273-5275 · smpeeling@peds.ufl.eduTimothy Foster · Principal investigatorMore trials in Gainesville
- Evolution Research Center · Hialeah, FL 33012Ana Fernandez · Study contact · 786-708-6008 · afernandez@evolutionresearchcenter.comJany Fundora · Study contact · jfundora@evolutionresearchcenter.comAndrea Sosa-Melo · Principal investigatorMore trials in Hialeah
- Nemours Children's Health · Jacksonville, FL 32207Jennifer Pann · Study contact · 904-776-2810 · jennifer.pann@nemours.orgLarry Fox · Principal investigatorMore trials in Jacksonville
- University of Miami · Miami, FL 33136Danay Saavedra · Study contact · 305-243-6616 · dxs4415@med.miami.eduJhanvi Doshi · Study contact · 305-243-3306 · jxd4468@med.miami.eduDavid Baidal · Principal investigatorMore trials in Miami
- DY Professional Research Center · Miami, FL 33176Yesenia Escarpio · Study contact · 3059828331 · yescarpio@dymedicalresearch.comSoroush Aghigh · Principal investigatorMore trials in Miami
- University of South Florida · Tampa, FL 33612Elizabeth Dunn · Study contact · 813-974-4886 · eadunn3@usf.eduHenry Rodriguez · Principal investigatorMore trials in Tampa
GA
- Atlanta Diabetes Association · Atlanta, GA 30318Amanda Maxson · Study contact · 404-355-4393 · amaxson@atlantadiabetes.comCarson Womack · Principal investigatorMore trials in Atlanta
- Emory University · Atlanta, GA 30322Meaza Girmay · Study contact · 404-778-6382 · meaza.girmay@emory.eduMichael Hughes · Principal investigatorMore trials in Atlanta
- Children's Healthcare of Atlanta · Atlanta, GA 30329Jordyn Turner · Study contact · 404-785-3690 · Jordyn.Turner@choa.orgKristina Cossen · Principal investigatorMore trials in Atlanta
ID
- Rocky Mountain Diabetes and Osteoporosis Center · Idaho Falls, ID 83404Ben Houston · Study contact · 208-525-3739 · ben.houston@rmclinicalresearch.comJoann Malone · Study contact · 208-528-9650 · joann.malone@rmclinicalresearch.comJoshua Smith · Principal investigatorMore trials in Idaho Falls
IL
- Ann & Robert H. Lurie Children's Hospital · Chicago, IL 60611Rohin Sagar · Study contact · 312-227-9403 · rsagar@luriechildrens.orgMaddie Lamphear · Study contact · 312-227-9403 · mlamphear@luriechildrens.orgNaomi Fogel · Principal investigatorMore trials in Chicago
- Northwestern University · Chicago, IL 60611Stefanie Hermann · Study contact · 312-926-8693 · s-herrmann@northwestern.eduEvelyn Fronczyk · Study contact · evelyn.guevara@northwestern.eduGrazia Aleppo · Principal investigatorMore trials in Chicago
- Southern Illinois University School of Medicine · Springfield, IL 62702Rebecca Owens · Study contact · 217-545-7321 · rowens29@siumed.eduKatharine Blancett · Study contact · 217-545-7799 · kblancett37@siumed.eduGabriel Uwaifo · Principal investigatorMore trials in Springfield
IN
- Riley Hospital for Children- Indiana University · Indianapolis, IN 46202Nate De Jong · Study contact · 317-278-4874 · nadejong@iu.eduLinda DeMeglio · Principal investigatorMore trials in Indianapolis
MA
- Joslin Diabetes Center · Boston, MA 02215Abigail Coryell · Study contact · 617-309-1909 · acoryell@joslin.harvard.eduJason Gaglia · Principal investigatorMore trials in Boston
MD
- Barry J. Reiner, MD, LLC · Baltimore, MD 21229Lee Bromberger · Study contact · 410-646-4009 · reinerstudy.lee@gmail.comAshley Hargrove · Study contact · reinerstudy.ashley2@gmail.comBarry Reiner · Principal investigatorMore trials in Baltimore
MI
- University of Michigan · Ann Arbor, MI 48109Adam Neidert · Study contact · 734-615-0539 · aneidert@med.umich.eduCarman Richison · Study contact · 734-615-6258 · caaguiar@med.umich.eduElif Oral · Principal investigatorMore trials in Ann Arbor
- Embassy Research Network · Bloomfield Township, MI 48302Zander Minano · Study contact · 248-622-4083 · zminano@embassyresearch.comGeorge Grunberger · Principal investigatorMore trials in Bloomfield Township
MN
- University of Minnesota · Minneapolis, MN 55454Veronica Jones-Carr · Study contact · 612-625-9709 · jone2678@umn.eduKali Johnson · Study contact · joh13933@umn.eduAntoinette Moran · Principal investigatorMore trials in Minneapolis
MO
- Children's Mercy Hospital · Kansas City, MO 64108Ashley Parks · Study contact · 816-302-8419 · anparks@cmh.eduWayne Moore · Principal investigatorMore trials in Kansas City
- Washington University School of Medicine · St Louis, MO 63110Elizabeth Sellitto · Study contact · 314-362-6821 · esellitto@wustl.eduJanet McGill · Principal investigatorMore trials in St Louis
NC
- Duke University · Durham, NC 27710Kia Gaskins · Study contact · 919-613-0234 · kiah.gaskin@duke.eduJennifer Green · Principal investigatorMore trials in Durham
- Physicians East, PA · Greenville, NC 27834Kirsten Goff · Study contact · 252-413-6299 · ktaylor@physicianseast.comMark Warren · Principal investigatorMore trials in Greenville
- Wake Research - Raleigh · Raleigh, NC 27612LaTosha Gonzalez · Study contact · 9192142514 · lgonzalez@wakeresearch.comFabricio Nunez · Study contact · fnunez@wakeresearch.comKhushbu Chandarana · Principal investigatorMore trials in Raleigh
- Superior Clinical Research · Smithfield, NC 27577Briana White · Study contact · 9199388058 · briana@superiorclinicalresearch.comMartha Dockery · Study contact · martha@superiorclinicalresearch.comClifford Curtis · Principal investigatorMore trials in Smithfield
NY
- UBMD Pediatrics - University of Buffalo · Buffalo, NY 14203Amanda House · Study contact · 716-323-0075 · ahouse@upa.chob.eduLucy Mastrandrea · Principal investigatorMore trials in Buffalo
- Hassenfield Children's Hospital · New York, NY 10016Jeniece Ilkowitz · Study contact · 212-263-9910 · jeniece.ilkowitz@nyulangone.orgMary Gallagher · Principal investigatorMore trials in New York
- NYU Langone Diabetes & Endocrine Associates · New York, NY 10017Amanda Baly · Study contact · 212-637-7000 · Amanda.Baly@nyulangone.orgRamachandra Naik · Principal investigatorMore trials in New York
OH
- University Hospitals Cleveland Medical Center · Cleveland, OH 44106Quiana Howard · Study contact · 216-286-0021 · Quiana.Howard@UHhospitals.orgJennie Phan · Study contact · 216-286-7454 · Jennie.Phan@Uhhospitals.orgBetul Hatipoglu · Principal investigatorMore trials in Cleveland
TN
- University Diabetes & Endocrine Consultants · Chattanooga, TN 37411Gina Harris · Study contact · 423-265-3561 · gharris@drhuffman.comDavid Huffman · Principal investigatorMore trials in Chattanooga
- Le Bonhuer Children's · Memphis, TN 38105Christine Watkins · Study contact · 901-287-5579 · christine.watkins@lebonheur.orgRamin Alemzadeh · Principal investigatorMore trials in Memphis
TX
- Texas Diabetes & Endocrinology · Austin, TX 78749Emmanuel Lopez · Study contact · 5123343505 · elopez@texasdiabetes.comOlivia Johnson · Study contact · ojohnson@texasdiabetes.comJean Chen · Principal investigatorMore trials in Austin
- M3 Wake Research - Dallas · Dallas, TX 75246Vicki Martinez · Study contact · 469-297-3074 · vmartinez@wakeresearch.comCarlos Arauz-Pacheco · Principal investigatorMore trials in Dallas
- Accurate Clinical Research, Inc · Humble, TX 77346Valerie Blanco · Study contact · 2817603930 · vblanco@accurateclinicalresearch.comSoamy Rivera · Study contact · srivera@accurateclinicalresearch.comBrian Chou · Principal investigatorMore trials in Humble
- Diabetes & Glandular Disease (DGD) Clinic, P.A. · San Antonio, TX 78229Bobbi Hernandez · Study contact · 2106148612 ext. 1088 · bobbi.hernandez@dgdclinic.comMonique Johnson · Study contact · monique.johnson@dgdclinic.comMark Kipnes · Principal investigatorMore trials in San Antonio
- TopLine Clinical, Inc · Waxahachie, TX 75165Lacey Powers · Study contact · 972-965-3247 · lacey@toplineclinical.comStephen Mueller · Principal investigatorMore trials in Waxahachie
WA
- Benaroya Research Institute · Seattle, WA 98101Erica Bourget · Study contact · 206-341-8997 · EBourget@benaroyaresearch.orgNatalie Clary · Study contact · 206-342-6963 · nclary@benaroyaresearch.orgKurt Griffin · Principal investigatorMore trials in Seattle
- University of Washington Diabetes Institute · Seattle, WA 98109Dori Khakpour · Study contact · 206-945-4965 · dorik@uw.eduIrl Hirsch · Principal investigatorMore trials in Seattle