Shingles vaccine and semaglutide for adults with recently diagnosed type 1 diabetes
Tests Shingrix and semaglutide, alone and together, in adults recently diagnosed with type 1 diabetes.
Plain-language title generated from the registry record
Registry title: SHIELD-T1D: Shingrix and GLP-1 Agonist for Beta-Cell Preservation in Recent-Onset Type 1 Diabetes.
Key facts
- Where
- Riyadh, Saudi ArabiaSee the site
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 50 years old?
Source: NCT07614412, who can take part
Where in Saudi Arabia
- Ministry of Health Medical CityRiyadh, Saudi ArabiaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Ministry of Health, Saudi Arabia
- Trial code
- NCT07614412
- Record updated
- 29 May 2026
- Original description
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.Read full original descriptionShow less
Recombinant Zoster Vaccine (Shingrix) and GLP-1 Receptor Agonist for the Preservation of Beta-Cell Function in Adults With Recent-Onset Type 1 Diabetes: A Randomized, Double-Blind, Placebo-Controlled Phase II Trial.
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.
Inclusion: 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.
Exclusion: 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; Current use of systemic corticosteroids or other immunosuppressive medications; History of diabetic ketoacidosis (DKA) within 4 weeks of screening; History of pancreatitis or medullary thyroid carcinoma; Active or chronic infection (e.g., HIV, Hepatitis B or C, Tuberculosis); Significant renal, hepatic, or cardiovascular disease; History of severe allergic reaction to any component of the Recombinant Zoster Vaccine (Shingrix) or semaglutide; Pregnancy or breastfeeding.