vTv Therapeutics (NASDAQ:VTVT) used a virtual key opinion leader event to outline the continuing burden of hypoglycemia in type 1 diabetes, present patient and physician market-research findings, and review the development program for its investigational oral therapy, cadisegliatin.
Paul Sekhri, the company’s chairman, president and chief executive officer, said the event was intended to examine hypoglycemia through clinical, patient and commercial perspectives. Cadisegliatin is in the company’s Phase III CATT1 trial, with top-line results expected in mid-2027, according to Sekhri.
Hypoglycemia remains a challenge despite technology
Dr. Schafer Boeder, medical director of Paradigm Clinical Research and associate professor of medicine at the University of California, San Diego, said type 1 diabetes results from an autoimmune attack on pancreatic beta cells, leading to an absolute or near-absolute insulin deficiency. He said approximately 2.1 million people in the U.S. and about 9.5 million globally live with the condition.
While continuous glucose monitors, insulin pumps and automated insulin-delivery systems have improved diabetes management, Boeder said they have not eliminated the risk of low blood glucose. Insulin administered under the skin acts more slowly and for longer than insulin produced naturally by the pancreas, he said, leaving patients exposed to hypoglycemia after insulin has been administered.
Boeder cited T1D Exchange data indicating that 34% of adults with type 1 diabetes not using continuous glucose monitoring reported at least one severe hypoglycemic event during the prior year, compared with 18% of continuous glucose monitor users. Among people using advanced automated insulin-delivery systems, approximately one in six reported a severe event, he said.
He also discussed a 2025 online survey of 674 U.S. adults with type 1 diabetes, sponsored by vTv and conducted by dQ&A. The survey population had high use of diabetes technology, with nearly two-thirds using automated insulin delivery and nearly all using continuous glucose monitoring. Boeder said 65% of respondents had at least one clinically meaningful hypoglycemia-related burden, including frequent level 2 hypoglycemia, a recent severe event, impaired awareness of hypoglycemia, or fear-driven behavior that prevented tighter glucose control.
Among automated insulin-delivery users specifically, more than half reported at least one such burden, according to Boeder. He said recurrent hypoglycemia can affect sleep, driving, work, exercise and social activities, while fear of low blood sugar may lead patients to maintain glucose levels above desired targets.
Patient perspective and commercial research
Cellist Alisa Weilerstein, who has lived with type 1 diabetes since age 9, described diabetes management as a continuous responsibility requiring planning around food, travel, exercise, work and family activities. She said the risk of hypoglycemia is particularly significant during performances because low blood sugar can impair fine motor skills, cause confusion and shakiness, and create a risk of falling.
Weilerstein said automated insulin delivery and continuous glucose monitoring have improved access to information and made management easier, but the technology remains imperfect. Sensors can lag blood glucose levels, she said, and patients must still respond to unpredictable changes in their glucose levels.
Martin Lafontaine, vTv’s chief commercial officer, said the company’s survey of more than 700 U.S. adults with type 1 diabetes found that 88% strongly or somewhat agreed with the statement, “I hate having low blood glucose.” Among respondents with HbA1c above 7%, he said nearly nine in 10 reported either keeping blood glucose higher than they should to avoid lows or said they would target lower glucose levels if not for hypoglycemia risk.
Lafontaine also cited vTv survey findings from U.S. and European endocrinologists. He said 85% of U.S. adult endocrinologists surveyed viewed the short-term risk of hypoglycemia as an equal or higher treatment priority than the long-term risk of hyperglycemia for most of their type 1 diabetes patients.
Cadisegliatin data and Phase III program
Dr. Klara Klein, an assistant professor at the University of North Carolina at Chapel Hill, described cadisegliatin, formerly known as TTP399, as a small-molecule glucokinase activator designed to act selectively in the liver rather than in pancreatic beta cells. The proposed mechanism is intended to increase liver glucose metabolism and glycogen storage, potentially providing glucose that can be mobilized when blood sugar falls.
Klein reviewed the Phase Ib/IIa SimpliciT1 study, which evaluated cadisegliatin as an adjunct to insulin. In one study portion involving 19 adults using insulin pumps and continuous glucose monitors, she said the treatment effect was a 0.7% reduction in HbA1c compared with placebo. In another portion involving 85 adults using multiple daily injections or pumps, with or without continuous glucose monitoring, the treatment effect was a 0.3% HbA1c reduction versus placebo.
She said cadisegliatin was well tolerated in the study, with treatment-emergent adverse events similar between groups. Post-hoc analysis showed fewer hypoglycemia events, according to Klein, while a separate insulin-withdrawal study did not show increased ketosis risk.
The Phase III CATT1 trial enrolled 166 participants, exceeding its 150-person target, Klein said. Participants are randomized to once-daily cadisegliatin, twice-daily cadisegliatin or placebo in addition to insulin. The primary endpoint is the incidence of level 2 or level 3 hypoglycemia over 26 weeks, while key secondary endpoints include changes in HbA1c.
Thomas Strack, vTv’s chief medical officer, said the study was designed and powered to show a 30% reduction in hypoglycemia over six months and to demonstrate at least non-inferiority in HbA1c. The trial also includes patient-reported measures covering quality of life, fear and burden of hypoglycemia, and hypoglycemia awareness, he said.
Sekhri said cadisegliatin has received FDA Breakthrough Therapy designation. He added that vTv ended the second quarter with $86.6 million in cash, which he said was sufficient to fund operations well beyond the expected CATT1 top-line readout.
About vTv Therapeutics (NASDAQ:VTVT)
vTv Therapeutics, Inc (NASDAQ: VTVT) is a clinical-stage biopharmaceutical company focused on developing orally administered small-molecule medicines for chronic diseases. The company’s research has primarily addressed metabolic and neurological disorders, including diabetes and Alzheimer’s disease.
vTv’s development portfolio has included cadisegliatin (also known as TTP399), an oral, liver-selective glucokinase activator being studied as a potential treatment for type 1 diabetes, and azeliragon, an investigational drug designed to inhibit the receptor for advanced glycation end products (RAGE) in Alzheimer’s disease.
