Health TrialsbyHealthPanel

VV-14299 and VV-14300 for the Treatment of Type 1 Diabetes

ConditionType 1 Diabetes Mellitus
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorKriya Therapeutics, Inc.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Sequential

Treatments tested in this trial

  • VV-14300

    Genetic

    VV-14300 will be administered via ultrasound-guided intramuscular injections.

  • VV-14299

    Genetic

    VV-14299 will be co-administered with VV-14300 via ultrasound-guided intramuscular injections.

Treatment groups

29 Participants
are divided into 4 treatment groups
Group A: Part 1 - Cohort 1 (VV-14300, single dose)Experimental treatment 1 intervention
Group B: Part 1 - Cohort 2 (VV-14300, single dose + VV-14299, low dose)Experimental treatment 2 interventions
Group C: Part 1 - Cohort 3 (VV-14300, single dose + VV-14299, high dose)Experimental treatment 2 interventions
Group D: Part 2 - Dose ExpansionExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Incidence and severity of adverse events, abnormal clinical laboratory values, abnormal physical exams, and abnormal vital signs

Safety of VV-14299 and/or VV-14300

Time frame
52 Weeks
2

Change from Baseline in blood glucose as measured by continuous glucose monitoring (CGM)

Efficacy of VV-14299 and/or VV-14300 (Part 1)

Time frame
16 Weeks
3

Change from Baseline in blood glucose as measured by hemoglobin A1c (HBA1c) level

Efficacy of VV-14299 and/or VV-14300 (Part 1)

Time frame
16 Weeks
4

Change from Baseline in blood glucose as measured by fructosamine level

Efficacy of VV-14299 and/or VV-14300 (Part 1)

Time frame
16 Weeks

Secondary outcomes

1

Mean change from Baseline in HbA1c levels

Efficacy of VV-14299 and/or VV-14300

Time frame
16, 26 (Part 1), and 52 Weeks
2

Change from Baseline in time-in-range derived from CGM data

Efficacy of VV-14299 and/or VV-14300

Time frame
52 Weeks
3

Change from Baseline in mean glucose concentration derived from CGM data

Efficacy of VV-14299 and/or VV-14300

Time frame
52 Weeks
4

Change from Baseline in Glucose Management Indicator (GMI) derived from CGM data

Efficacy of VV-14299 and/or VV-14300

Time frame
52 Weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Kriya Therapeutics, Inc.

Lead sponsor

Source ClinicalTrials.gov
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