vTv Therapeutics Announces FDA has Lifted Clinical Hold on Cadisegliatin Program for Diabetes
Rhea-AI Summary
vTv Therapeutics (VTVT) announced that the FDA has lifted the clinical hold on its cadisegliatin program, including the CATT1 Phase 3 trial for type 1 diabetes (T1D). The company plans to amend the protocol to reduce the trial duration from 12 to 6 months, expediting the path to larger pivotal studies needed for NDA submission.
Cadisegliatin, an oral liver-selective glucokinase activator, aims to be the first oral adjunctive therapy to insulin for T1D. The drug has shown good tolerability in over 500 subjects with up to six months of treatment. The primary endpoint of measuring level 2 and 3 hypoglycemia rates at 6 months remains unchanged.
The clinical hold, initially placed on July 26, 2024, was due to an unresolved chromatographic signal in a human ADME study. The hold was lifted on March 14, 2025, after vTv demonstrated the signal was an experimental artifact. No patients had been dosed in the CATT1 trial during the hold period, and previous studies showed no concerning safety issues.
Positive
- FDA lifted clinical hold on cadisegliatin program
- Trial duration reduction from 12 to 6 months accelerates path to NDA submission
- Potential first-in-class oral adjunctive therapy for type 1 diabetes
- Strong safety profile with 500+ subjects treated
Negative
- Previous clinical hold delayed development timeline
- Protocol amendment required for trial continuation
News Market Reaction – VTVT
In the trading session that priced this news, VTVT gained 53.13%, reflecting a significant positive market reaction.
Data tracked by StockTitan Argus on the day of publication.
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Cadisegliatin has the potential to be the first oral adjunct therapy for type 1 diabetes
CATT1 Phase 3 trial expected to resume following submission of protocol amendment shortening the overall duration of the trial from 12 to 6 months
HIGH POINT, N.C., March 17, 2025 (GLOBE NEWSWIRE) -- vTv Therapeutics Inc. (Nasdaq: VTVT), a clinical stage biopharmaceutical company focused on the development of cadisegliatin, a potential first-in-class oral adjunctive therapy to insulin being investigated for the treatment of type 1 diabetes (T1D), today announced that the United States Food and Drug Administration (FDA) has lifted the clinical hold on the cadisegliatin clinical program, which includes the CATT1 Phase 3 trial in type 1 diabetes (T1D). Cadisegliatin is an oral, liver-selective glucokinase activator that has been generally well tolerated in over 500 subjects to date with up to six months of treatment.
vTv Therapeutics expects to resume the trial following submission of a protocol amendment to reduce the overall duration of the CATT1 trial from 12 months to 6 months, which will help to expedite the initiation of required larger pivotal studies for future New Drug Application (NDA) submission. The original primary endpoint of ascertaining level 2 and 3 hypoglycemia rates at 6 months will not change. The planned amendment will not include the additional 6-month period to collect safety data. By shortening the trial from 12 to 6 months, the Company will be able to obtain topline data from the study more quickly.
“We are pleased that the FDA has lifted the clinical hold on our cadisegliatin program and are eager to resume our Phase 3 trial. Importantly, we plan to submit a protocol amendment to reduce the time to topline data by 6-months, which will allow us to initiate our larger Phase 3 studies sooner to support our future NDA submission,” said Paul Sekhri, Chairman, President and Chief Executive Officer of vTv Therapeutics. “Cadisegliatin has the potential to be the first oral adjunctive therapy to insulin for T1D and we look forward to further evaluating the effects of cadisegliatin on glycemic control and incidence of hypoglycemia over insulin alone after reinitiating the CATT1 Phase 3 trial.”
On July 26, 2024, vTv Therapeutics announced a clinical hold on the CATT1 Phase 3 trial based on the discovery of a chromatographic signal in a human absorption, distribution, metabolism, and excretion (ADME) study of cadisegliatin that could not be resolved by standard mass spectroscopy. No patient had been dosed in the CATT1 trial at the time of the clinical hold, and past clinical studies did not reveal any clinically concerning safety issues. The clinical hold was lifted as of March 14, 2025, following submission of a complete response letter by vTv Therapeutics which concluded that the chromatographic signal was an experimental artifact.
About Cadisegliatin
Cadisegliatin (TTP399) is a novel, oral small molecule, liver selective glucokinase activator being investigated as a potential first-in-class oral adjunctive treatment to insulin for type 1 diabetes (T1D). In nonclinical studies, cadisegliatin, acting selectively on the liver, increased the activity of glucokinase independently from insulin, which supports clinical investigation of improvement in glycemic control through hepatic glucose uptake and glycogen storage.
Cadisegliatin is under investigation and the safety and efficacy have not been established. There is no guarantee that this product will receive health authority approval or become commercially available for the use being investigated.
About vTv Therapeutics
vTv Therapeutics Inc. is a late stage biopharmaceutical company focused on developing novel oral, small molecule drug candidates intended to help treat millions with chronic diseases. vTv’s clinical pipeline is led by cadisegliatin, a potential first-in-class oral adjunctive therapy to insulin being investigated for the treatment of type 1 diabetes.
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