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Platform Trial in Stage 1 Diabetes: Comparing Golimumab vs Placebo

NCT07683026 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 255

Last updated 2026-07-06

No results posted yet for this study

Summary

The goal of this clinical trial is to learn if golimumab is effective at preventing progression to Stage 2 diabetes in participants with presymptomatic Type 1 Diabetes. The expected duration of this study is approximately 6 years.

Participants will:

* Take golimumab or placebo injections monthly for the duration of the study or until they are diagnosed with either stage 2 or stage 3 Type 1 Diabetes
* Visit a study clinic every 6 months for Oral Glucose Tolerance Tests (OGTTs) and other tests until the end of the study

Conditions

  • Type 1 Diabetes (T1D)

Interventions

DRUG

Golimumab

Golimumab will be given as a subcutaneous formulation based on the participant's weight at baseline. A loading dose regimen at 0 and 2 weeks will be followed by monthly maintenance doses for the duration of the participant's enrollment in the study. For those weighing 15kg to less than 40 kg the dosing will be: 100mg (week 0), followed by 50mg monthly thereafter. For those weighing 40kg or more the loading dose will be 200mg (week 0) followed by 100mg thereafter.

DRUG

Placebo (matching golimumab)

0.9% Sodium Chloride Injection USP ("Normal" saline) is to be dispensed as the placebo for this study. A loading dose regimen at 0 and 2 weeks will be followed by monthly maintenance doses for the duration of the participant's enrollment in the study.

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    lead NIH

Principal Investigators

  • Jason Gaglia, MD · TrialNet

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
44 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-08
Primary Completion
2032-09-01
Completion
2032-09-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07683026 on ClinicalTrials.gov