A Multi-Center, Randomized, Double-Blind, Parallel-Group, Multiple-Dose, Adaptive Study Assessing the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of TTP399 in With Adult Patients Type 1 Diabetes Mellitus

The purpose of this study is to evaluate the safety and efficacy of TTP399 in Type 1 diabetics. This study will be in 2 phases: phase 1 will evaluate the safety of different TTP399 dosage regimens over 1 week of daily dosing. Phase 2 will evaluate the safety and efficacy of a TTP399 dosing regimen over 12 weeks of daily dosing.

Start Date25 Oct 2017

Sponsor / Collaborator

vTv Therapeutics, Inc.

[+1]

NCT02405260

/ CompletedPhase 2

A Multi-Center, Adaptive Phase 2, Randomized, Double-Blind, Placebo- and Active-Controlled (Sitagliptin), Parallel Group Study to Evaluate the Safety and Efficacy of TTP399 Following 6 Months Administration in Subjects With Type 2 Diabetes Mellitus on A Stable Dose of Metformin

This trial is a multi-center, adaptive, randomized, double-blind, placebo- and active- controlled, parallel group, Phase 2 study in subjects with T2DM to evaluate the effect of TTP399 on HbA1c following administration for 6 months.

Start Date01 Mar 2015

Sponsor / Collaborator

vTv Therapeutics, Inc.

100 Clinical Results associated with Cadisegliatin

100 Translational Medicine associated with Cadisegliatin

100 Patents (Medical) associated with Cadisegliatin

Literatures (Medical) associated with Cadisegliatin

01 Oct 2024·MICROBIAL PATHOGENESIS

Identification of small molecule glucokinase activators for the treatment of diabetes based on plants from the traditional Chinese medicine: In silico analysis

Article

Author: Moussamih, Samya ; Douiyeh, Imane ; Safi, Amal ; Kettani, Anass ; Regragui, Anas ; Khamlich, Jihane ; Saih, Asmae

Mutations in glucokinase (GCK) can either enhance or inhibit insulin secretion, leading to different forms of diabetes, including gestational diabetes. While many glucokinase activators (GKAs) have been explored as treatments, their long-term effectiveness has often been unsatisfactory. However, recent interest has surged with the introduction of dorzagliatin and TTP399. This study investigates the efficacy of four previously studied compounds (Swertiamarin, Apigenin, Mangiferin, and Tatanan A) in activating GCK using computational methods. Initial molecular docking revealed binding affinities ranging from -6.7 to -8.6 kcal/mol. The compounds were then evaluated for drug-likeness and pharmacokinetic properties. Re-docking studies were performed for validation. Based on their favorable binding affinities and compliance with Lipinski's rule and ADMET criteria, three compounds (Swertiamarin, Apigenin, and Tatanan A) were selected for molecular dynamics (MD) simulations. MD simulations demonstrated that Swertiamarin showed excellent stability, as indicated by analyses of RMSD, RMSF, radius of gyration (Rg), hydrogen bonding, and principal component analysis (PCA). These results suggest that Swertiamarin holds promise for further investigation in in vivo and clinical settings to evaluate its potential in enhancing GCK activity and treating diabetes. This study assessed the potential of four compounds as GCK activators using molecular docking, pharmacokinetic profiling, and MD simulations. Swertiamarin, in particular, showed significant stability and adherence to drug-likeness criteria, making it a promising candidate for further research in combating diabetes.

01 Aug 2022·Diabetes, obesity & metabolism

Impact of the hepatoselective glucokinase activator TTP399 on ketoacidosis during insulin withdrawal in people with type 1 diabetes

Article

Author: Dvergsten, Chris ; Klein, Klara R. ; Madduri, Supradeep ; Buse, John B. ; Giovannetti, Erin R. ; Boeder, Schafer C. ; Pettus, Jeremy H. ; Freeman, Jennifer L. R. ; Valcarce, Carmen ; Dunn, Imogene

Abstract:

Aims:

To determine the effect of TTP399, a hepatoselective glucokinase activator, on the risk of ketoacidosis during insulin withdrawal in individuals with type 1 diabetes (T1D).

Materials and methods:

Twenty‐three participants with T1D using insulin pump therapy were randomized to 800 mg TTP399 (n = 12) or placebo (n = 11) for 7 to 10 days. After the treatment period, an insulin withdrawal test (IWT) was performed, during which insulin pumps were removed to induce ketogenesis. The IWT was stopped after 10 hours or if blood glucose reached >399 mg/dL [22.1 mmol/L], if beta‐hydroxybutyrate (BHB) was >3.0 mmol/L, or for patient discomfort. The primary endpoint was the proportion of participants who reached BHB concentrations of 1 mmol/L or greater.

Results:

During the 7‐ to 10‐day treatment period, mean fasting plasma glucose was significantly reduced ( −27.6 vs. −4.4 mg/dL [−1.5 vs. −0.2 mmol/L]; P = 0.03) and there were fewer adverse events, including hypoglycaemia, in the TTP399‐treated arm. During the IWT, no differences were observed between TTP399 and placebo in mean serum BHB concentration, mean duration of IWT, or BHB at termination of IWT. However, serum bicarbonate was numerically higher and urine acetoacetate was quantitatively lower in the TTP399‐treated participants. As a result of higher bicarbonate values, none of the TTP399‐treated participants met the prespecified criteria for diabetic ketoacidosis (DKA), defined as BHB >3 mmol/L and serum bicarbonate <18 mEq/L, compared to 42% of placebo‐treated participants.

Conclusions:

When used as an adjunctive therapy to insulin, TTP399 improves glycaemia without increasing hypoglycaemia in individuals with T1D. During acute insulin withdrawal, TTP399 did not increase BHB concentrations and decreased the incidence of DKA.

01 Jun 2022·Journal of diabetes and metabolic disorders

Targeting human Glucokinase for the treatment of type 2 diabetes: an overview of allosteric Glucokinase activators

Review

Author: Grewal, Ajmer Singh ; Guarve, Kumar ; Singh, Sukhbir ; Sharma, Neelam ; Singla, Deepak ; Sharma, Prateek

Diabetes mellitus is a worldwide impacting disorder and the ratio through which the number of diabetic patients had increased worldwide, puts medical professionals to serious stress for its effective management. Due to its polygenic origin and involvement of multiple genes to its pathophysiology, leads to understanding of this ailment more complex. It seems that current interventions, such as dietary changes, life style changes and drug therapy such as oral hypoglycaemics and insulin, are unable to halt the trend. There are various novel and emerging targets on which the researchers are paying attention to combat with this ailment successfully. Human glucokinase (GK) enzyme is one of these novel and emerging targets for management of diabetes. Its availability in the pancreas and liver cells makes this target more lucrative. GK's presence in the pancreatic and hepatic cells plays a very important function for the management of glucose homoeostasis. Small molecules that activate GK allosterically provide an alternative strategy for restoring/improving glycaemic regulation, especially in type 2 diabetic patients. Although after enduring many setbacks in the development of the GK activators, interest has been renewed especially due to introduction of novel dual acting GK activator dorzagliatin, and a novel hepato-selective GK activator, TTP399. This review article has been formulated to discuss importance of GK in glucose homeostasis, recent updates on small molecules of GK activators, clinical status of GK activators and challenges in development of GK activators.

News (Medical) associated with Cadisegliatin

18 Mar 2025

·www.globenewswire.com

vTv Therapeutics Announces FDA has Lifted Clinical Hold on Cadisegliatin Program for Diabetes

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 March 17, 2025 -- 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. 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. 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. The content above comes from the network. if any infringemenlease contact us to modify.

NDA

09 Dec 2024

·www.prnewswire.com

CANTEX PHARMACEUTICALS RECEIVES FDA ORPHAN DRUG DESIGNATION FOR AZELIRAGON FOR THE TREATMENT OF BRAIN METASTASIS FROM BREAST CANCER

WESTON, Fla., Dec. 9, 2024 /PRNewswire/ -- Cantex Pharmaceuticals, Inc., a clinical-stage pharmaceutical company focused on developing transformative therapies for cancer and other life-threatening medical conditions, announced today that the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation to Cantex's azeliragon for the treatment of brain metastasis from breast cancer. This new azeliragon designation adds to azeliragon's two other Orphan Drug Designations for the treatment of pancreatic cancer and glioblastoma, received in mid-2024 and early 2023, respectively. Cantex's azeliragon is a well-tolerated compound, administered orally once-a-day, that inhibits the receptor for advanced glycation end products (known as RAGE). The binding of RAGE on cancer cells to S100 proteins and other ligands has been linked to resistance to radiation, disease progression, and development of metastasis in breast cancer. The development of brain metastasis is a life-threatening complication of breast cancer. Although critically important life-extending advances in the treatment of brain metastasis from some forms of breast cancer have recently been made, brain metastasis from triple-negative breast cancer, an aggressive subtype of breast cancer, remains a therapeutic challenge greatly in need of improved treatments. "Receiving FDA Orphan Drug Designation for azeliragon for the treatment of brain metastasis from breast cancer highlights a continued need for new treatment options for these patients," commented Stephen G. Marcus, M.D., Chief Executive Officer of Cantex. "This designation reflects our continued commitment to developing new azeliragon treatment options for patients with life-threatening cancer." In addition to azeliragon's already issued composition of matter and other patents, FDA Orphan Drug Designations provide Cantex with seven years of azeliragon marketing exclusivity from the time of product launch for the orphan indication, and several other important benefits, including assistance in the drug development process, tax credits for clinical costs, and exemptions from certain FDA fees. About Azeliragon Azeliragon is an orally administered capsule, taken once daily, that inhibits interactions of the receptor for advanced glycation end products (known as RAGE) with certain ligands, including HMGB1 and S100 proteins in the tumor microenvironment. Azeliragon was discovered by and originally under development for Alzheimer's disease by vTv Therapeutics Inc. (NASDAQ: VTVT) from which Cantex licensed worldwide rights to azeliragon. Clinical safety data from those trials, involving more than 2000 individuals dosed for periods up to 18 months, indicate that azeliragon is very well tolerated. Cantex has ongoing clinical trials in brain metastasis, glioblastoma, breast cancer, pancreatic cancer, and hospitalized patients with pneumonia. These trials are based on azeliragon's robust preclinical data as well as its extensive clinical safety information from randomized placebo-controlled clinical trials. About Cantex Pharmaceuticals, Inc. Cantex Pharmaceuticals, Inc. is a privately held, clinical stage pharmaceutical company focused on developing transformative therapies for cancer and other life-threatening medical conditions for which new treatments are urgently needed. For more information, please visit . About vTv Therapeutics Inc. vTv Therapeutics Inc. is a late-stage biopharmaceutical company focused on developing oral, small molecule drug candidates. vTv's clinical pipeline is led by cadisegliatin, a potential adjunctive therapy to insulin for the treatment of type 1 diabetes patients. vTv and its development partners are investigating additional indications including type 2 diabetes and other chronic conditions. To learn more please visit vtvtherapeutics.com. Contacts: Cantex Pharmaceuticals, Inc. Stephen G. Marcus, M.D. +1 954-315-3660 [email protected] Juan F. Rodriguez +1 954-315-3660 [email protected] Tiberend Strategic Advisors, Inc. Investors Jon Nugent +1 646-577-8520 [email protected] Media Casey McDonald +1 646-577-8520 [email protected] SOURCE Cantex Pharmaceuticals, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Orphan Drug

02 Dec 2024

·www.globenewswire.com

vTv Therapeutics to Participate in 7th Annual Evercore HealthCONx Conference

HIGH POINT, N.C., Dec. 02, 2024 (GLOBE NEWSWIRE) -- vTv Therapeutics Inc. (Nasdaq: VTVT), a clinical stage biopharmaceutical company with a portfolio of novel small molecules and a lead program in diabetes, today announced that management will participate in a fireside chat and be available for one-on-one meetings at the 7th Annual Evercore HealthCONx Conference to be held in Coral Gables. Florida, December 3 – 5, 2024. 7th Annual Evercore HealthCONx Conference Presentation Date:December 4, 2024 Time:7:55 – 8:15 AM ET Webcast Link:click here A live webcast of the presentation will be available via the Events section of the Company’s investor relations website at https://ir.vtvtherapeutics.com/events. To request a meeting or for more details about the conference please reach out to your institutional contact or email. About vTv Therapeutics vTv Therapeutics Inc. is a late-stage biopharmaceutical company focused on developing oral, small molecule drug candidates. vTv's clinical pipeline is led by cadisegliatin, a potential adjunctive therapy to insulin for the treatment of type 1 diabetes. vTv and its development partners are investigating additional indications including type 2 diabetes and other chronic conditions. Forward-Looking StatementThis release contains forward-looking statements, which involve risks and uncertainties. These forward- looking statements can be identified by the use of forward-looking terminology, including the terms “anticipate,” “believe,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and, in each case, their negative or other various or comparable terminology. All statements other than statements of historical facts contained in this release, including statements regarding the timing of our clinical trials, our strategy, future operations, future financial position, future revenue, projected costs, prospects, plans, objectives of management and expected market growth are forward-looking statements. These statements involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance, or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Important factors that could cause our results to vary from expectations include those described under the heading “Risk Factors” in our Annual Report on Form 10-K and our other filings with the SEC. These forward-looking statements reflect our views with respect to future events as of the date of this release and are based on assumptions and subject to risks and uncertainties. Given these uncertainties, you should not place undue reliance on these forward-looking statements. These forward-looking statements represent our estimates and assumptions only as of the date of this release and, except as required by law, we undertake no obligation to update or review publicly any forward-looking statements, whether as a result of new information, future events or otherwise after the date of this release. We anticipate that subsequent events and developments will cause our views to change. Our forward-looking statements do not reflect the potential impact of any future acquisitions, merger, dispositions, joint ventures, or investments we may undertake. We qualify all of our forward-looking statements by these cautionary statements. Contact Ashley Robinson LifeSci Advisors, LLCarr@lifesciadvisors.com

100 Deals associated with Cadisegliatin

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Indication	Highest Phase	Country/Location	Organization	Date
Diabetes Mellitus, Type 1	Phase 3	United States	vTv Therapeutics, Inc.	14 Jun 2024
Diabetes Mellitus, Type 2	Phase 2	United States	vTv Therapeutics, Inc.	01 Mar 2015

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03335371 (Simplici-T1 \| The Simplici-T1 Trial \| SimpliciT1, CTgov)	Phase 1/2	Diabetes Mellitus, Type 1	115	Placebo (Part 1 Placebo)	cpucqwrzcq(rvjcjiurdm) = jsnotnykgn ckmmxfosga (uuefqqshug, 0.2) View more	-	03 Jul 2023
				TTP399 (Part 1 TTP399 800 mg)	cpucqwrzcq(rvjcjiurdm) = ddwysuibkh ckmmxfosga (uuefqqshug, 0.2) View more
ADA2022	Not Applicable	Diabetes Mellitus, Type 1	23	TTP399	rpoukpwboj(sqxykjtggp) = No patients on TTP399 met prespecified criteria for DKA while 43% of subjects on placebo did ceswbfyrbn (dflozhaiai ) View more	-	01 Jun 2022
				Placebo
NCT03335371 (SimpliciT1, Pubmed \| Diabetes Care)	Phase 1/2	Diabetes Mellitus, Type 1	115	TTP399 800 mg	yrupjqmmef(mvoyvkkmgo) = wwppmkuysy tmobpdjwwx (horrgrzucl, -1.3, - 0.07)	Positive	23 Feb 2021
NCT03335371 (Simplici-T1, EASD2020)	Phase 1/2	Diabetes Mellitus, Type 1	-	TTP399 800mg	vbcxfqtckh(brfestdwpb) = estrgpmtwo hiysnykgom (eehawvgxrq ) View more	Positive	22 Sep 2020
				Placebo	hifawjkkes(jecxcvyrkl) = rfgpcywawy tcwyxovpsc (jpvdaqcttg )
NCT03335371 (Simplici-T1, EASD2020)	Phase 1/2	Diabetes Mellitus, Type 1	-	TTP399 800mg	chtqctqaqo(byhktjqymy) = uxuojphmue brchgphtvq (ibnjyvpiam, -0.5 to -0.01) View more	Positive	22 Sep 2020
NCT03335371 (The Simplici-T1 Trial, ADA2020)	Phase 1/2	Diabetes Mellitus, Type 1	85	TTP399 800 mg	oeflevstna(hgdzentdha) = lqozzrqzeb wljnhcubgo (ynldfdzqmc, -0.50, - 0.13) View more	Positive	01 Jun 2020
				Placebo	oeflevstna(hgdzentdha) = yjotgbzztt wljnhcubgo (ynldfdzqmc, -0.38, - 0.02) View more
NCT03335371 (Simplici-T1, EASD2019)	Phase 1/2	Diabetes Mellitus, Type 1	-	TTP399 400mg daily dose	nqeogidvsd(kioszyqdbt) = nslpyastbt jaglpzcuhq (mrjrpctjdn )	Positive	18 Sep 2019
NCT02405260 (Pubmed \| Sci Transl Med) Manual	Phase 2	Diabetes Mellitus	190	TTP399	vwwhsoxzqe(vcyeuewgwe) = TTP399 (800 mg/day) was associated with a clinically significant and sustained reduction in glycated hemoglobin, with a placebo-subtracted least squares mean HbA1c change from baseline of -0.9% qpnqbyuntr (sigqdvewnz ) View more	Positive	16 Jan 2019
				Placebo

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