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type1.science

Golimumab (anti-TNF)

Janssen (Simponi; repurposed)

An anti-TNF monoclonal antibody tested in the T1GER phase-2 trial in children and young adults with new-onset T1D. It preserved C-peptide and reduced insulin use over one year, with off-therapy follow-up signals. It is not approved for T1D and has never been shown to prevent onset. A TrialNet platform substudy registered to start in August 2026 would be the first test of it in presymptomatic, normal-glucose stage-1 T1D — but it has not begun enrolling.

On the horizonModerate evidenceimmunotherapyrepurposedanti-tnfmonoclonal-antibodybeta-cell-preservation

The scorecard

Delay of onset48

New-onset T1GER preserved C-peptide at 52 weeks, but golimumab has never been shown to delay clinical onset. That is now being tested directly: the primary endpoint of the new stage-1 platform substudy is time to confirmed dysglycemia or clinical diabetes.[1]

Durability45

Two-year follow-up reported continued off-therapy metabolic improvements, but the evidence base remains one main phase-2 program.[2]

Safety52

Anti-TNF drugs have broad inflammatory-disease experience, but infection risk and chronic immune suppression are important concerns for young T1D patients.[4]

Stage breadth30

Efficacy evidence is new-onset (stage 3) only. A TrialNet stage-1 substudy (NCT07683026) is registered but not yet recruiting (start Aug 2026, one site, readout ~2032) — a plan, not evidence. Earlier presymptomatic attempts were an 8-person phase-1b that tested safety alone and a stage-2 prevention trial withdrawn without enrolling anyone.[5]

Access & cost20

Marketed for other autoimmune diseases but not T1D; diabetes use is investigational/off-label and biologic pricing limits reach.[4]

Editor’s take

Golimumab is too important to omit: T1GER was a clean pediatric/young-adult signal that anti-TNF biology can preserve beta-cell function. The quiet news of 2026 is that TrialNet is finally taking that signal upstream — into people who are autoantibody-positive but still have normal glucose. It is a real prevention attempt, not a press release. But it starts in August 2026 and reads out around 2032, and golimumab remains a repurposed chronic biologic with safety and access baggage. Nothing about this makes it a practical prevention tool today.

The full picture

What it tested

Golimumab is an antibody against tumor necrosis factor alpha (TNF-alpha), a major inflammatory cytokine. The T1GER study tested whether blocking TNF soon after diagnosis could preserve the beta cells that remain.

Evidence and limits

T1GER randomized 84 children and young adults aged 6-21 with new-onset T1D to golimumab or placebo for 52 weeks. C-peptide was significantly higher with golimumab at week 52, insulin use was lower, and partial remission was more common.1

This is beta-cell preservation, not a demonstrated prevention of T1D onset. Anti-TNF therapy also carries chronic immune-suppression considerations that weigh heavily when the candidate population is young and otherwise healthy.

New in 2026: the first real prevention trial

Everything above happened after diagnosis. That is about to change. TrialNet and the NIDDK have registered a phase-2 golimumab substudy (protocol TN39A, NCT07683026) inside an adaptive platform trial aimed squarely at prevention.2

It plans to enrol 255 people aged 2 to 44 who have presymptomatic T1D — either two or more islet autoantibodies, or a confirmed IA-2A antibody alone — and who still have normal glucose tolerance on an oral glucose tolerance test. That is stage 1: the immune attack has started, but blood sugar has not budged yet. Participants are randomised 1:2 to placebo or golimumab, given as weight-based loading doses at weeks 0 and 2 and then monthly. The primary endpoint is the one that matters — how long it takes to develop confirmed dysglycemia or overt, symptomatic diabetes.

Some honest caveats, because the calendar is long and the details are unsettled:

  • The trial is not yet recruiting. Estimated start is 8 August 2026, with primary completion around September 2032 — roughly three years of recruitment and three years of follow-up. Nobody will know whether this works for about six years.
  • Only one site (Joslin Diabetes Center, Boston) is listed so far, despite the protocol describing itself as multicentre.
  • The registry entry contradicts itself: the structured fields say 255 participants, ages 2-44, while the free-text description says 225 participants and refers to people under 18. The record looks mid-revision. We cite the structured fields and will correct this if it settles differently.

This is not the first time golimumab has been given to someone before diagnosis, but it is the first time it has been given a fair test. A Janssen phase-1b in stage-2 presymptomatic T1D (NCT03298542) enrolled just 8 people, tested safety only, and never posted results. A separate NIDDK stage-2 prevention trial (NCT04729296) was withdrawn during COVID-19 without enrolling anyone. TN39A is the first anti-TNF trial in stage 1, and the first adequately powered presymptomatic attempt to actually get off the ground.

Until it reads out, the honest position stands: golimumab preserves beta-cell function in people who already have T1D, and may delay onset in people who don't. Only one of those is proven.

References

  1. Quattrin T, et al. Golimumab and Beta-Cell Function in Youth with New-Onset Type 1 Diabetes. New England Journal of Medicine (2020). https://doi.org/10.1056/NEJMoa2006136 ↩

  2. Adaptive Platform Trial to Delay Progression From Normoglycemia to Dysglycemia in Presymptomatic Type 1 Diabetes — Golimumab Substudy. ClinicalTrials.gov NCT07683026 (NIDDK/TrialNet, protocol TN39A; record retrieved 2026-07-14). https://clinicaltrials.gov/study/NCT07683026 ↩

Coming soon

ETA · Phase-2 stage-1 prevention substudy starting Aug 2026; onset-delay data ~6 years away

  • →TrialNet adaptive-platform substudy (NCT07683026) — monthly golimumab vs placebo in 255 normoglycaemic, autoantibody-positive people aged 2-44; primary endpoint is time to dysglycemia or clinical T1D · Starting August 2026; ~6-year study

Sources

  1. [1]Golimumab and Beta-Cell Function in Youth with New-Onset Type 1 Diabetes · peer-reviewed · 2020-11-19 — PMID 33207093. Phase 2; n=84; ages 6-21; 4-hour C-peptide AUC at week 52 0.64 vs 0.43 pmol/mL (P<0.001).
  2. [2]Two-Year Follow-up From the T1GER Study · peer-reviewed · 2023-03-01 — PMID 36576974. Off-therapy metabolic follow-up after golimumab.
  3. [3]A Study of SIMPONI to Arrest Beta-cell Loss in Type 1 Diabetes · registry · 2025-02-04 — ClinicalTrials.gov NCT02846545; completed; actual enrollment 84.
  4. [4]SIMPONI (golimumab) prescribing information · regulatory · 2019-10-01 — FDA label for approved non-T1D indications; no T1D indication.
  5. [5]Adaptive Platform Trial to Delay Progression From Normoglycemia to Dysglycemia in Presymptomatic Type 1 Diabetes — Golimumab Substudy · registry · 2026-07-14 — NIDDK/TrialNet protocol TN39A; phase 2; not yet recruiting; n=255; ages 2-44; randomised 1:2 placebo:golimumab; estimated start 8 Aug 2026; primary completion Sept 2032. The registry record is internally inconsistent — the free-text description says 225 participants and refers to persons under 18, while the structured fields say 255 and ages 2-44. The record appears mid-revision; the structured fields are cited here.