NCT06025110

Brief Summary

The goal of this study is to determine if treatment with TCD601 improves beta-cell function in adults recently diagnosed with type 1 diabetes compared to placebo.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jan 2023

Geographic Reach
5 countries

26 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 23, 2023

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 25, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 6, 2023

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 24, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 24, 2025

Completed
Last Updated

August 14, 2025

Status Verified

August 1, 2025

Enrollment Period

2.5 years

First QC Date

August 25, 2023

Last Update Submit

August 11, 2025

Conditions

Diabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in beta-cell function as compared to placebo at week 52.

    Assess any changes in beta-cell function at the end of the study (week 52) for patients treated with TCD601 (study drug) compared to subjects treated with placebo (the comparator).

    52 weeks

Secondary Outcomes (1)

  • Assess the incidence and severity of adverse

    52 weeks

Study Arms (2)

TCD601

EXPERIMENTAL

Administered one of three doses of TCD601 over a 12 week treatment period.

Biological: TCD601

Placebo

PLACEBO COMPARATOR

Placebo is administered over a 12 week treatment period.

Other: Placebo

Interventions

TCD601BIOLOGICAL

Investigational Product

TCD601
PlaceboOTHER

Comparator

Placebo

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Able to understand the study requirements and provide written informed consent before any study assessment is performed
  • Male or female patients ≥ 18 to 45 years of age
  • A diagnosis of type 1 diabetes

You may not qualify if:

  • Women who are pregnant, lactating, or planning on pregnancy during the study
  • History of cancer
  • History of heart disease
  • Recent infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (26)

UZ Brussel

Brussels, 1090, Belgium

Location

UZ Leuven

Leuven, 3000, Belgium

Location

Azienda Ospedaliero-Universitaria Renato Dulbecco

Catanzaro, 88100, Italy

Location

San Raffaele Hospital

Milan, 20132, Italy

Location

Luigi Sacco Hospital

Milan, 20157, Italy

Location

University of Siena

Siena, 53100, Italy

Location

Hospital Clinic de Barcelona

Barcelona, 08036, Spain

Location

Hospital Universitari de Bellvitge

Barcelona, 08907, Spain

Location

Hospital Universitari de Girona Dr. Josep Trueta

Girona, 17007, Spain

Location

Hospital General de Segovia

Segovia, 40002, Spain

Location

Hospital Universitario Virgen del Rocío

Seville, 41013, Spain

Location

Hospital Clinico Universitario de Valladolid

Valladolid, 47003, Spain

Location

Karolinska University Hosptial

Stockholm, Sweden

Location

Dorset County Hospital NHS Foundation Trust

Dorchester, Dorset, DT1 2JY, United Kingdom

Location

Liverpool University Hospitals NHS Foundation Trust

Liverpool, Merseyside, L7 8YE, United Kingdom

Location

University of Birmingham

Birmingham, United Kingdom

Location

Bradford Teaching Hospitals NHS Foundation Trust

Bradford, BD9 6DA, United Kingdom

Location

Cambridge University Hospitals NHS Foundation Trust

Cambridge, United Kingdom

Location

Ninewells Hospital

Dundee, DD1 9SY, United Kingdom

Location

St George's University Hospitals NHS Foundation Trust

London, SW17 0QT, United Kingdom

Location

Guy's and St. Thomas' NHS Foundation Trust

London, United Kingdom

Location

East Kent Hospitals University NHS Foundation Trust

Margate, CT9 4AN, United Kingdom

Location

Norfolk and Norwich University Hospitals NHS Foundation Trust

Norwich, NR4 7UY, United Kingdom

Location

Oxford University Hospitals NHS Foundation Trust

Oxford, OX3 7LE, United Kingdom

Location

Northern Care Alliance NHS Foundation Trust

Salford, M6 8HD, United Kingdom

Location

Swansea Bay University Health Board

Swansea, United Kingdom

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Fredrik Juhlin

    ITB-MED

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 25, 2023

First Posted

September 6, 2023

Study Start

January 23, 2023

Primary Completion

July 24, 2025

Study Completion

July 24, 2025

Last Updated

August 14, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)BE(2)GB(13)IT(4)ES(6)