CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 47 enrolled
Drug / intervention
NNC0361-0041 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04279613
NCT04279613Phase 1Completed
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A Multiple Ascending Dose Trial Investigating Safety, Tolerability and Pharmacokinetics of NNC0361-0041 Administered Subcutaneously to Patients With Type 1 Diabetes Mellitus

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)·interventional·Posted Feb 21, 2020·Updated May 20, 2025

In Brief

A Phase 1 clinical trial evaluating NNC0361-0041 and Placebo for Type I Diabetes. Completed, enrolled 47 participants across 16 sites.

Detailed Summary

The trial is a placebo-controlled, double-blinded within cohorts, randomized, multiple ascending dose trial with a sequential trial design. The primary outcome is to investigate the safety and tolerability of ascending subcutaneous weekly doses of NNC0361-0041 plasmid in patients with T1D.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType I Diabetes
CountriesUnited States
CollaboratorsNovo Nordisk A/S

Timeline

Phase 1CompletedFinished
2020202120222023202420252026
First PostedFeb 21, 2020
Enrollment StartNov 23, 2020
Primary CompletionAug 31, 2023
Study CompletionApr 24, 2024
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 6.4 years ago

Interventions

NNC0361-0041drug

Recombinant supercoiled plasmid encoding four human proteins: (pre-proinsulin (PPI), transforming growth factor β1 (TGF-β1), interleukin-10 (IL-10), and interleukin-2 (IL-2) is administered s.c. via syringe and needle.

Placeboother

Placebo