Anti-IL-21 antibody + liraglutide
What it is
A discontinued combination programme that preserved more C-peptide during a Phase 2 trial, with benefits diminishing after treatment stopped. It remains historical evidence, not an available T1D therapy.
Editorial review: . What was checked and what remains uncertain.
Latest dated source in the citation list: 2021-04-09. This is the source’s date, not a new review of every claim.
Trial status, labels and access can change between reviews.
Evidence behind this assessment
Key evidence notes. Study results, product eligibility and access answer different questions.
- Who was studied?
- Study populations and analysis groups vary. Product age limits alone do not describe who was studied.See the linked studies and their populations →
- Benefit or performance
- Beta-cell preservation: The randomized Phase 2 combination improved the week-54 C-peptide primary endpoint versus placebo; individual components did not.[1]
- Important harms and treatment burden
- Safety: Gastrointestinal events were common; one death occurred in the liraglutide-only arm, judged unlikely related by investigators.[1]
- Approval and country access
- A discontinued combination programme that preserved more C-peptide during a Phase 2 trial, with benefits diminishing after treatment stopped. It remains historical evidence, not an available T1D therapy.Approval, trial recruitment, local supply and funding are separate. Check the cited label or access source.
- Follow-up and remaining uncertainty
- Durability: Effects diminished during the 26 weeks after treatment withdrawal.[1]
This record cites company or conference reports. Those sources may describe interim findings; their source type is shown in the source list.
Editorial score: calculation and evidence
A weighted editorial judgment on a 0–100 scale, not a probability of success or a measured treatment effect. Higher criterion scores mean more favorable assessments.
Default calculation: 50 × 30 + 20 × 20 + 40 × 20 + 25 × 10 + 40 × 20 = 3750; divide by total weight 100. Unrounded weighted result: 37.5.
The randomized Phase 2 combination improved the week-54 C-peptide primary endpoint versus placebo; individual components did not.[1]
Gastrointestinal events were common; one death occurred in the liraglutide-only arm, judged unlikely related by investigators.[1]
The trial enrolled adults 18–45 with recent-onset T1D and residual beta-cell function.[2]
Phase 2 completed; Novo Nordisk discontinued development in 2020 after reviewing the regulatory path.[3]
The full picture
What the trial found
The trial randomized 308 adults across four groups, 77 per group. At week 54, C-peptide had declined by approximately 10% with the combination versus 39% with placebo (estimated treatment ratio 1.48, 95% CI 1.16–1.89; P=0.0017). This is insulin-secretion preservation, not a 48% improvement in glucose control or insulin independence. Neither component alone met this comparison; HbA1c differences were not significant. Benefits diminished off treatment.1
Why it is historical
Novo Nordisk announced in October 2020 that it discontinued development after evaluating the regulatory path. That is a company programme decision, separate from the later peer-reviewed publication of the trial. The FDA orphan record explicitly states that the combination is not approved for the designated indication.2 3
This historical combination has distinct evidence from GLP-1 drugs used as glucose or weight adjuncts. It does not provide an active treatment pathway for people with T1D.
Sources
- [1]Anti-IL-21 antibody and liraglutide in recent-onset T1D: randomized Phase 2 trial · peer-reviewed · 2021-03-01 — Novo Nordisk-funded trial; 308 randomized is not the treated-analysis denominator.
- [2]NCT02443155 — study record · registry · 2021-04-09 — Registry update date; retrieved 16 September 2026. Registry registration is not proof of clinical benefit.
- [3]Novo Nordisk Q3 2020 financial report: combination development discontinued · manufacturer · 2020-10-30
- [4]FDA orphan designation record for NNC0114-0006 plus liraglutide · regulatory — Designation is not approval; the record says not FDA approved for the orphan indication.