SHIELD-T1D: Shingrix and GLP-1 Agonist for Beta-Cell Preservation in Recent-Onset Type 1 Diabetes.

Starting soon · Phase 2 · Has a placebo group

Conditions studied: Type 1 Diabetes Mellitus

In brief

Type 1 diabetes (T1D) is a chronic autoimmune disease characterized by progressive destruction of pancreatic beta cells mediated by autoreactive T lymphocytes, resulting in absolute insulin deficiency. Preservation of residual beta-cell function at the time of diagnosis is a critical therapeutic window, as even marginal endogenous insulin secretion - reflected by detectable C-peptide levels - is associated with improved glycemic control, reduced hypoglycemia burden, and decreased long-term vascular complication rates. This study evaluates the hypothesis that combinatorial immunomodulation - using the AS01B adjuvant system within the Recombinant Zoster Vaccine (RZV; Shingrix, GSK) alongside metabolic and cytoprotective support via a GLP-1 receptor agonist (semaglutide) - can synergistically preserve residual beta-cell function in adults within 100 days of T1D diagnosis. The AS01B adjuvant system activates innate immune pathways that promote regulatory T-cell (Treg) expansion and shift the immunological milieu toward tolerance, while GLP-1 receptor agonism provides direct beta-cell cytoprotection, reduces glucotoxicity, and may suppress autoimmune cytokine signaling. SHIELD-T1D is a randomized, double-blind, placebo-controlled, parallel-group Phase II clinical trial enrolling 240 adults (18-50 years) diagnosed with T1D within 100 days, with confirmed residual beta-cell function (stimulated C-peptide ≥0.2 nmol/L). Participants are randomized 1:1:1:1 to one of four arms: (1) Shingrix alone, (2) Semaglutide alone, (3) Shingrix + Semaglutide combination, or (4) dual placebo. The primary endpoint is change in 2-hour stimulated C-peptide AUC during a Mixed Meal Tolerance Test (MMTT) from baseline to 12 months. This phase II randomized, double-blind, placebo-controlled multicenter trial will evaluate the efficacy and safety of the recombinant zoster vaccine (Shingrix) and a glucagon-like peptide-1 (GLP-1) receptor agonist, alone and in combination, for preservation of residual beta-cell function in adults with recent-onset type 1 diabetes. The working hypothesis is that combining AS01 adjuvant-mediated immunomodulation with the metabolic and cytoprotective actions of a GLP-1 receptor agonist will provide dual protection for pancreatic beta cells, slowing autoimmune destruction and improving functional insulin secretion compared with placebo.

Key facts

Study ID: NCT07614412
Run by: Ministry of Health, Saudi Arabia
People needed: 240
Starts: 2027-01-01
Expected to finish: 2028-12-31
Last updated by the study team: 2026-05-29

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Diagnosis of Type 1 Diabetes (T1D) according to American Diabetes Association (ADA) criteria.
Age 18 to 50 years (inclusive) at the time of screening.
Randomization within 100 days of the first insulin injection.
Confirmed residual beta-cell function, defined as a peak stimulated C-peptide level ≥0.2 nmol/L during a Mixed Meal Tolerance Test (MMTT) performed at screening.
Presence of at least one T1D-related autoantibody (GADA, IA-2A, ZnT8A, or ICA).
Willingness to comply with intensive insulin therapy and glucose monitoring.
Females of childbearing potential must have a negative pregnancy test and agree to use highly effective contraception.

You may not qualify if…

History of diabetic ketoacidosis (DKA) within 4 weeks of screening.
Prior use of any immunotherapy or investigational agents for T1D.
Current or prior use of GLP-1 receptor agonists, DPP-4 inhibitors, or SGLT2 inhibitors.
History of pancreatitis or medullary thyroid carcinoma.
Active or chronic infection (e.g., HIV, Hepatitis B or C, Tuberculosis).
Pregnancy or breastfeeding.
Significant renal, hepatic, or cardiovascular disease.
History of severe allergic reaction to any component of the Recombinant Zoster Vaccine (Shingrix) or semaglutide.
Current use of systemic corticosteroids or other immunosuppressive medications.

Where it is running

Ministry of Health Medical City — Riyadh, Saudi Arabia

Full record on ClinicalTrials.gov

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