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
18 – 65
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
29 (estimated)
Sponsor
Kriya Therapeutics, Inc. · Industry
Who this trial is looking for
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
This study is testing VV-14299 and VV-14300 or VV-14300 alone in adults with long-standing type 1 diabetes (T1D) whose blood sugar is not well controlled despite using an automated insulin delivery (AID) system. VV-14299 and VV-14300 are investigational gene therapies that are injected into muscle and are designed to work together to help remove excess sugar from the blood.
Trial Locations
Loading…
Loading trial locations…
Facility
City
State
Country
Status
Eligibility Criteria
Inclusion Criteria:
* Able to provide signed informed consent.
* 18 to 65 years of age (inclusive) at Screening.
* Body mass index (BMI) of 20.0 to \<30.0 kg/m².
* Clinical diagnosis of Type 1 Diabetes (T1D) for at least 5 years prior to Screening, currently managed with an Automated Insulin Delive…
Inclusion Criteria:
* Able to provide signed informed consent.
* 18 to 65 years of age (inclusive) at Screening.
* Body mass index (BMI) of 20.0 to \<30.0 kg/m².
* Clinical diagnosis of Type 1 Diabetes (T1D) for at least 5 years prior to Screening, currently managed with an Automated Insulin Delivery (AID) system for at least 3 months prior to Screening.
* Suboptimal glycemic control (C-peptide \<0.20 ng/mL \[0.667 nmol/L\] during a mixed meal tolerance test; HbA1c \>7% and \<10%); and on a stable insulin regimen at Screening.
* Adequate kidney function (estimated glomerular filtration rate \[eGFR\] \>60 mL/min/1.73m²) at Screening.
* Females of child-bearing potential must have a negative pregnancy test at Screening and prior to dosing; participants must agree to use highly effective contraception during and for at least 12 months after study intervention administration
* Agree to refrain from donating blood, plasma, platelets, eggs, or sperm during the 12-month Post-Treatment Follow-up Period.
* Willing and able to complete all study visits, procedures, and required use study-provided monitoring devices for the duration of the study.
Exclusion Criteria:
* Type 2 diabetes or other condition requiring exogenous insulin that is not due to autoimmunity, or when insulin delivery is not managed through an AID system.
* Diabetic complications (e.g., severe/proliferative retinopathy or neuropathy) or a clinically significant medical, cognitive, or psychiatric condition that, in the Investigator's opinion, poses additional risk or would make consistent study follow-up unlikely.
* Pregnant or breastfeeding.
* History of malignancy requiring chemotherapy and/or radiation within the 12 months prior to Screening, except for successfully treated non-melanoma skin cancers (e.g., basal cell, squamous cell carcinomas), cervical intraepithelial neoplasia, and localized prostate cancer.
* Clinically significant cardiovascular or cerebrovascular disease, uncontrolled blood pressure, family history of Long QT syndrome, or clinically significant ECG abnormality.
* Significant history of alcohol or drug abuse, or positive alcohol breath test or urine drug screen at the Screening or Run-in visit.
* Plans to implement new strenuous physical activity (e.g., significantly increased running pace/duration, high-intensity interval training, heavy weightlifting, vigorous cycling) during the study.
* Impaired awareness of hypoglycemia.
* Documented anti-AAV1 neutralizing antibody titer above the protocol-specified threshold at Screening.
* Active hepatitis B or C infection, positive HIV serology, or any latent or active infection that would interfere with study procedures or be exacerbated by study medications.
* Clinically significant abnormal Screening laboratory or other diagnostic findings (including hepatic, hematologic, thyroid, muscle-enzyme, or tuberculosis screening) rendering the participant unsuitable for the study.
* Current or recent use of medications that could interfere with glucose metabolism or confound study assessments (e.g., glucocorticoids, systemic beta-blockers, growth hormone, or other antidiabetic medications \[e.g., glucagon-like peptide 1 (GLP-1) receptor agonists and/or sodium-glucose cotransport 2 (SGLT2) inhibitors\]).
* Vaccination within 30 days prior to dosing or planned vaccination within 8 weeks post-dosing.
* Screening laboratory findings indicating undue risk of a tocilizumab-related adverse event.
* History of bariatric surgery within the 12 months prior to Screening.
* History of trauma to, or other findings affecting the suitability of, the muscles intended for study intervention administration.
* Participation in another investigational drug or biologic trial within 6 months prior to Screening, or participation in any previous gene therapy trial.
Picking one helps us show the most relevant trials first.
Your results are loading in the background — you can
change this any time from the results page.
Set your location to continue
Find My Trials uses your location to surface clinical trials near you.
Add your city or zip code to your profile and try again.