Health TrialsbyHealthPanel

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-14300 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-14300 is an investigational gene therapy that is injected into muscle and is designed 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 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.

Recurrent diabetic ketoacidosis (2 or more events in the 12 months prior to Screening).

Pregnant or breastfeeding.

Trial design

Design model

Sequential

Treatments tested in this trial

  • VV-14300

    Genetic

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

Treatment groups

29 Participants
are divided into 3 treatment groups
Group A: Part 1 - Low doseExperimental treatment 1 intervention
Group B: Part 1 - High doseExperimental treatment 1 intervention
Group C: Part 2 - Dose ExpansionExperimental treatment 1 intervention

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-14300

Time frame
52 Weeks
2

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

Efficacy of VV-14300 (Part 1)

Time frame
8 Weeks
3

Change from Baseline in blood glucose as measured by hemoglobin A1c (HbA1c) level

Efficacy of VV-14300 (Part 1)

Time frame
8 Weeks
4

Change from Baseline in blood glucose as measured by fructosamine level

Efficacy of VV-14300 (Part 1)

Time frame
8 Weeks

Secondary outcomes

1

Mean change from Baseline in HbA1c

Efficacy of VV-14300

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

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

Efficacy of VV-14300

Time frame
52 Weeks
3

Change from Baseline in mean glucose concentration derived from CGM data

Efficacy of VV-14300

Time frame
52 Weeks
4

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

Efficacy of 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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