vTv Therapeutics Announces Oral Presentation at Breakthrough T1D Clinical and Research Congress 2026

Over half of T1D adults using AID systems still face significant hypoglycemia burdens.

What the company is saying

vTv Therapeutics is highlighting new research presented by Chief Medical Officer Thomas Strack at CRC 2026, showing that hypoglycemia remains a substantial problem for adults with type 1 diabetes (T1D) even when using automated insulin delivery (AID) systems. The company emphasizes that 24% of AID users report frequent Level 2 hypoglycemia, 7% keep their glucose higher to avoid hypoglycemia, and 49% would target lower glucose if not for hypoglycemia risk. After segmenting and weighting, 54% of AID users experience at least one hypoglycemia-related burden. CEO Paul Sekhri frames these findings as evidence that insulin and current technologies are insufficient, reinforcing the need for adjunctive therapies. The announcement positions cadisegliatin, their oral glucokinase activator, as a potential solution, noting its Breakthrough Therapy designation by the FDA but clearly stating that its safety and efficacy are not yet established. The company’s tone is measured, focusing on unmet need and the rationale for ongoing clinical development rather than making efficacy claims.

What the data suggests

The research surveyed 674 adults with T1D, including 429 using AID systems. Among these AID users, 24% reported frequent Level 2 hypoglycemia, 7% strongly agreed they keep their blood glucose higher to avoid hypoglycemia, and 49% strongly agreed they would aim for lower glucose if not for hypoglycemia risk. After accounting for overlapping burdens and weighting for A1C, 54% of AID users were estimated to experience at least one hypoglycemia-related burden. These figures indicate that despite technological advances, a majority of adults with T1D on AID systems still face clinically meaningful hypoglycemia challenges. No clinical efficacy or safety data for cadisegliatin are disclosed in this announcement, and no financial or operational metrics for vTv Therapeutics are provided. The only forward-looking element is the mention of cadisegliatin’s ongoing Phase 3 investigation and its Breakthrough Therapy designation, with no claims about clinical outcomes or regulatory timelines.

Analysis

The announcement is primarily a factual disclosure of research findings on hypoglycemia-related burdens in adults with T1D using AID systems, supported by specific prevalence data from a commissioned study. While the company references its lead clinical candidate, cadisegliatin, and its Breakthrough Therapy designation, it explicitly states that safety and efficacy have not been established and that there is no guarantee of approval or commercialisation. No new clinical or financial data are presented, and there are no exaggerated claims about imminent benefits or commercial impact. The tone is measured, and forward-looking statements are appropriately caveated. There is no evidence of narrative inflation or overstatement relative to the disclosed facts.

Risk flags

• ●The absence of new clinical efficacy or safety data for cadisegliatin means there is no evidence yet that the drug will address the hypoglycemia burden identified in the research. This creates a major uncertainty around the product's future value.
• ●Regulatory approval risk remains high, as cadisegliatin’s safety and efficacy have not been established and there is no guarantee of FDA or other health authority approval. The Breakthrough Therapy designation signals potential but does not ensure market entry.
• ●The company does not disclose any financial, cash, or operational data in this update, leaving investors without visibility into funding runway, burn rate, or ability to sustain long-term clinical development.

Bottom line

This announcement demonstrates that hypoglycemia remains a widespread and serious issue for adults with T1D, even among those using advanced AID systems, with 54% experiencing at least one significant burden. vTv Therapeutics uses these findings to justify the continued development of cadisegliatin, but provides no new clinical, financial, or operational data. The Breakthrough Therapy designation is a positive regulatory milestone but does not reduce the high risk inherent in late-stage drug development. Investors should recognize that the path to commercial value is long and contingent on successful Phase 3 results and regulatory approval, neither of which are addressed in this update. The most important takeaway is that while the unmet need is clear and quantified, the company has not yet demonstrated that its lead candidate can meet it.

Announcement summary

(NASDAQ:VTVT) vTv Therapeutics Inc. announced that Chief Medical Officer Thomas Strack, M.D., Ph.D., presented research at the Breakthrough T1D Clinical & Research Congress (CRC 2026) in Philadelphia, PA, focusing on hypoglycemia-related burdens among adults with type 1 diabetes (T1D) using automated insulin delivery (AID) systems. The research, titled “A Cumulative Population View of Hypoglycemia-Related Burdens in T1D Adults Using AID Systems,” was a quantitative online study commissioned by vTv Therapeutics and conducted by dQ&A Market Research, Inc., involving 674 adults with T1D, of whom 429 were using AID systems. Among adult AID system users, 24% reported experiencing frequent Level 2 hypoglycemia, defined as daily, almost daily, or a few moderate hypoglycemic events. 7% of respondents strongly agreed that they often keep their blood glucose higher to avoid hypoglycemia. 49% strongly agreed that they would target lower glucose levels if not for the risk of hypoglycemia. After segmenting respondents across four hypoglycemia-related burden dimensions and weighting for A1C, approximately 54% of adults with T1D using an AID system were estimated to experience at least one of these burdens. Paul Sekhri, Chairman, President, and Chief Executive Officer of vTv Therapeutics, stated that these findings highlight the limitations of insulin and the ongoing impact of hypoglycemia on daily glucose management for people with T1D. Richard Wood, Chief Executive Officer of dQ&A Market Research, Inc., commented that the findings underscore the challenges faced by people with T1D, even those using advanced technologies like AID systems, and expressed optimism about new therapies that could complement existing technologies. Cadisegliatin (TTP399), vTv’s lead clinical candidate, is a novel, oral small-molecule glucokinase activator being investigated in the U.S. as a potential first-in-class adjunctive treatment for T1D. Nonclinical studies have shown that cadisegliatin acts selectively on the liver and increases glucokinase activity independently of insulin, supporting further clinical investigation. Cadisegliatin has been granted Breakthrough Therapy designation by the U.S. Food and Drug Administration (FDA). The safety and efficacy of cadisegliatin have not been established, and there is no guarantee that it will receive health authority approval or become commercially available. vTv Therapeutics is a late-stage biopharmaceutical company focused on developing oral, small molecule drug candidates for diabetes and other chronic diseases, with cadisegliatin currently being investigated in a U.S. Phase 3 study for T1D. vTv and its development partners are also investigating multiple molecules across different indications for chronic diseases. dQ&A Market Research, Inc. is a diabetes-focused research firm conducting ongoing surveys and research with patients and caregivers across the United States, Canada, and Europe.

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