Last update 27 Jun 2024

ZT-01

Last update 27 Jun 2024

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

ZT 01, ZT-01

Target

SSTR2

Mechanism

SSTR2 antagonists(Somatostatin receptor 2 antagonists)

Therapeutic Areas

Immune System DiseasesEndocrinology and Metabolic Disease

Active Indication

Diabetes Mellitus, Type 1Hypoglycemia

Inactive Indication

Diabetes Mellitus, Type 2

Originator Organization

York University

Tulane University Hospital & Clinic

University of Toronto

Active Organization

Zucara Therapeutics, Inc.Startup

Inactive Organization

New York University

Drug Highest PhasePhase 2

First Approval Date-

Regulation-

Clinical Trials associated with ZT-01

NCT05762107 / RecruitingPhase 2

A Phase 2a Randomized, Double-blind, Placebo-controlled, Multiple-dose, Crossover Study of the Effect of ZT-01 on Frequency of Nocturnal Hypoglycemia in Type 1 Diabetes Mellitus

The goal of this clinical trial is to learn about the effect of the study drug (ZT-01) on low blood sugar (hypoglycemia) in adults with type 1 diabetes (T1D) who have been having low blood sugars ("hypos") at night. ZT-01 increases the amount of a hormone called glucagon during low blood sugar, and this may help prevent the occurrence of hypos. The main questions this trial aims to answer are whether ZT-01 lowers the number of hypos happening at night, and what its effects are on blood sugar levels. The safety of ZT-01 will also be measured.
Participants will be asked to wear a study-provided continuous glucose monitor (CGM) during two 4-week periods when they will self-inject the study drug before bed. They will get ZT-01 at one of three dose levels during one period, and placebo (which looks like the study drug but doesn't contain the active ingredient) during the other. Neither the participant nor the study site will know what they are receiving during each treatment period or see data from the CGM. The participant will continue to use their usual methods of measuring blood sugar (including their personal CGM) and giving insulin during the study. The participant will be asked to complete a short diary each evening, and will be asked to upload the CGM data to a study phone every day.
If a participant uses their own CGM and is willing to share information on how often they have low blood sugar with the study site at the first visit to see if they meet study entry requirements, they will have 6 study visits, 2 study phone calls, and be in the study for about 16 weeks. If they don't use CGM or don't want to share their information, then they will be asked to wear a study CGM for an extra 4 weeks to find out how many low blood sugars they have, and will have an extra visit.
Study participants will be asked to give blood and urine for testing to see whether they meet the requirements to enter the study, and at the start and end of each treatment period to see if the study treatment has any effects. They will also have their blood pressure and temperature taken at each study visit, and have an ECG at 4 visits to measure the electrical activity of their heart.
Some participants will be asked to also take part in a sub-study where their blood level of ZT-01 and glucagon is measured, after the first and last dose. They will be asked to stay at the study site overnight for each set of measurements (4 in total).

Start Date28 Jul 2023

Sponsor / Collaborator

Zucara Therapeutics, Inc.Startup

NCT05007977 / TerminatedPhase 1

Pharmacodynamic Evaluation of ZT-01 in a Stepped Hypoglycemic Clamp Model in Subjects With Type 1 Diabetes Mellitus

The purpose of this study is to determine whether ZT-01 increases the glucagon response to hypoglycemia in type 1 diabetes (T1D). ZT-01 is a specific somatostatin (SST) type 2 receptor antagonist hypothesized to increase the counterregulatory glucagon release during hypoglycemia, which is impaired in diabetes, and may thus reduce the occurrence of hypoglycemia.
Approximately 25 participants with well-controlled type 1 diabetes will be recruited to a crossover study and be randomized to the order in which they receive a single administration of placebo, low dose and high dose ZT-01 during three euglycemic-hypoglycemic clamps 2 to 6 weeks apart, with a follow-up visit approximately 1 week after the final clamp.
Participants will stay overnight in the clinic before each clamp, and their plasma glucose (PG) will be kept at euglycemic levels with IV insulin and dextrose as needed. The following morning, the clamp will begin and the subject's PG will be kept at 5.5 mmol/L (euglycemia) with variable IV insulin (and dextrose as needed). Study treatment will be administered during this euglycemic period, and then insulin will be increased so that PG falls to a plateau of mild hypoglycemia, and then increased further to clinically significant hypoglycemia. Release of glucagon and other counterregulatory hormones will be measured, and a symptom score will be completed, during euglycemia before and following study treatment, and during each level of hypoglycemia. Following the clamp, the participant's blood glucose will be returned to normal levels prior to leaving the clinic.

Start Date08 Jul 2021

Sponsor / Collaborator

Zucara Therapeutics, Inc.Startup

100 Clinical Results associated with ZT-01

100 Translational Medicine associated with ZT-01

100 Patents (Medical) associated with ZT-01

Literatures (Medical) associated with ZT-01

01 Jun 2023·Diabetes, obesity & metabolism

Effects of somatostatin receptor type 2 antagonism during insulin‐induced hypoglycaemia in male rats with prediabetes

Article

Author: Atherley, Sara ; Liggins, Richard ; D'Souza, Ninoschka C. ; Hoffman, Emily G. ; Aiken, Julian ; Riddell, Michael C.

Abstract:

Aims:

To examine if glucagon counterregulatory defects exist in a rat model of prediabetes (pre‐T2D) and to assess if a selective somatostatin receptor 2 antagonist (SSTR2a), ZT‐01, enhances the glucagon response to insulin‐induced hypoglycaemia.

Materials and methods:

Hyperglycaemia was induced in 8‐ to 9‐week‐old male, Sprague‐Dawley rats via 7 weeks of high‐fat diet followed by a single, low‐dose intraperitoneal injection of streptozotocin (30 mg/kg). After 2 weeks of basal insulin therapy (0‐4 U/d insulin glargine, administered subcutaneously [SC]) to facilitate partial glycaemic recovery and a pre‐T2D phenotype, n = 17 pre‐T2D and n = 10 normal chow‐fed control rats underwent the first of two hypoglycaemic treatment‐crossover experiments, separated by a 1‐week washout period. On each experimental day, SSTR2a (3 mg/kg ZT‐01, SC) or vehicle was administered 1 hour prior to insulin‐induced hypoglycaemia (insulin aspart, 6 U/kg, SC).

Results:

Glucagon counterregulation was marginally reduced with the induction of pre‐T2D. Treatment with SSTR2a raised peak plasma glucagon levels and glucagon area under the curve before and after insulin overdose in both and pre‐T2D rats. Blood glucose concentration was elevated by 30 minutes after SSTR2a treatment in pre‐T2D rats, and hypoglycaemia onset (≤3.9 mmol/L) was delayed by 15 ± 12 minutes compared with vehicle (P < 0.001), despite similar glucose nadirs in the two treatment groups (1.4 ± 0.3 mmol/L). SSTR2a treatment had no effect on blood glucose levels in the control group or on the hypoglycaemia‐induced decline in plasma C‐peptide levels in either group.

Conclusions:

Treatment with an SSTR2a increases glucagon responsiveness and delays the onset of insulin‐induced hypoglycaemia in this rat model of pre‐T2D where only a modest deficiency in glucagon counterregulation exists.

01 May 2022·Diabetes, obesity & metabolismQ2 · MEDICINE

ZT‐01: A novel somatostatin receptor 2 antagonist for restoring the glucagon response to hypoglycaemia in type 1 diabetes

Q2 · MEDICINE

Article

Author: D'Souza, Ninoschka C. ; Farhat, Rawad ; Appadurai, Daniel ; Simonson, Eric ; Liggins, Richard T. ; Aiken, Julian ; Riddell, Michael C. ; Hull, Grayson ; Chan, Owen

Abstract:

Aim:

To evaluate the pharmacokinetics and efficacy of a novel somatostatin receptor 2 antagonist, ZT‐01, to stimulate glucagon release in rats with type 1 diabetes (T1D).

Methods:

The pharmacokinetics of ZT‐01 and PRL‐2903 were assessed following intraperitoneal or subcutaneous dosing at 10 mg/kg. We compared the efficacy of ZT‐01 with PRL‐2903 to prevent hypoglycaemia during an insulin bolus challenge and under hypoglycaemic clamp conditions.

Results:

Within 1 hour after intraperitoneal administration, ZT‐01 achieved more than 10‐fold higher plasma Cmax compared with PRL‐2903. Twenty‐four hour exposure was 4.7× and 11.3× higher with ZT‐01 by the intraperitoneal and subcutaneous routes, respectively. The median time to reach hypoglycaemia of more than 3.0 mmol/L was 60, 70, and 125 minutes following vehicle, PRL‐2903, or ZT‐01 administration, respectively. Furthermore, rats receiving ZT‐01 had significantly higher glucose nadirs following insulin administration compared with PRL‐2903– and vehicle–treated rats. During the hypoglycaemic clamp, ZT‐01 increased peak glucagon responses by ~4‐fold over PRL‐2903.

Conclusions:

We conclude that ZT‐01 may be effective in restoring glucagon responses and preventing the onset of hypoglycaemia in patients with T1D.

01 May 2021·International immunopharmacologyQ2 · MEDICINE

Exploring a novel triptolide derivative possess anti-colitis effect via regulating T cell differentiation

Q2 · MEDICINE

Article

Author: Zhou, Yu ; Chen, Chengjuan ; Sun, Tao ; Wu, Lei ; Zhang, Tiantai ; Zhang, Dongming ; Zang, Yingda ; Fu, Junmin ; Shao, Shuai ; Shi, Gaona ; Zhu, Guoyuan

Inflammatory bowel disease (IBD) is generally characterized by chronic inflammatory disorders of the gastrointestinal tract that are known as ulcerative colitis (UC) or Crohn's disease (CD). Although the underlying mechanism of action of IBD is unclear and because of the lack of satisfactory treatment, increasing evidence has indicated that pro-inflammatory cytokines that activate JAK-STAT signaling pathway regulate the differentiation of naïve T cells towards T helper (Th)1 and Th17 cell subsets and contribute to the development of IBD. ZT01 is a newly obtained triptolide derivative with strong anti-inflammatory effects and low toxicity. In this study, we evaluated the effects of ZT01 on DSS-induced colitis and investigated the underlying mechanism of action involved. Mice with DSS-induced acute or chronic colitis were used to assess the efficacy of ZT01 treatment, and T cells were cultured to analyze the differentiation of Th1 and Th17 cell by flow cytometry. In addition, intestinal epithelial barrier function, macrophage polarization, activation of the JAK-STAT signaling pathway, and the expression of cytokines and transcription factors were measured to assess the possible mechanisms of ZT01. We found that ZT01 had an obviously beneficial effect on DSS-induced colitis by improving the symptoms of bloody diarrhea, weight loss, and a shortened colon, thereby preserving the epithelial barrier function in the mouse colon. Furthermore, ZT01 significantly inhibited T cell differentiation into Th1 and/or Th17 cell subsets and macrophage polarization towards into an inflammatory phenotype via regulating the JAK-STAT signaling pathway. Thus, our findings suggested that ZT01 might be a potential pharmaceutical candidate that deserves to be further investigated as a treatment for IBD patients.

News (Medical) associated with ZT-01

25 Sep 2023

·www.biospace.com

Zucara Therapeutics Doses First Patient in Phase 2a 'ZONE' Trial

- ZONE study to evaluate the effect of ZT-01 on preventing nighttime hypoglycemia in people with Type 1 diabetes - - ZT-01 has the potential to become the first therapeutic to prevent nocturnal hypoglycemia, a condition for which there are currently no available therapies - TORONTO, Sept. 25, 2023 /PRNewswire/ -Zucara Therapeutics Inc., ("Zucara" or the "Company") a diabetes life sciences company developing the first once-daily therapeutic to prevent hypoglycemia (low blood glucose levels) in people with diabetes, today announced that it has dosed the first patient in its Phase 2a trial of the effect of ZT-01 On Nocturnal hypoglycemia Events in Type 1 diabetes ("T1D") mellitus ("ZONE"). "Dosing the first patient in Zucara's ZONE trial is the Company's most significant milestone to date, and advances what could be the first preventative solution to potentially dangerous nighttime low blood glucose levels," said Michael Midmer, Zucara Therapeutics' Chief Executive Officer. "Nighttime hypoglycemia remains a significant challenge in diabetes management and is a great source of fear for people with diabetes, parents and their caregivers. We believe ZT-01 could greatly improve quality of life by preventing these low blood sugar events which are an ongoing disruption to many people with T1D and can lead to serious complications and poorer health outcomes." The ZONE study is a multi-centre, randomized, double-blinded, placebo-controlled, multiple-dose, crossover study designed to evaluate the effect of ZT-01 on the frequency of nocturnal hypoglycemia in patients with T1D. Patients will self-administer one of three doses of ZT-01, or placebo, every evening before bed each for a four-week period. Patients will be monitored for hypoglycemia events using a continuous glucose monitor. The study's primary endpoint is the rate of nocturnal hypoglycemic events, compared to placebo. Secondary endpoints include the number of patients experiencing adverse events and time spent in hypoglycemia compared to placebo. Dr. Alex Abitbol, who previously evaluated ZT-01 in a Phase 1b study and will be a principal investigator for ZONE, commented, "The positive results from the proof-of-concept Phase 1b study of ZT-01 were intriguing: in addition to observing a rise in glucagon, we also saw a corresponding rise in glucose during hypoglycemia. This suggests that ZT-01 can prevent nocturnal hypoglycemia, which is what we aim to confirm in the ZONE trial." The ZONE study is actively recruiting and will enroll patients at as many as 15 clinical sites across Canada and the U.S. Recruitment is expected to be completed in 2024. Zucara previously announced positive results from its proof-of-concept Phase 1b study of ZT-01 in people with T1D demonstrating that nearly 90% of patients had a meaningful increase in glucagon release following ZT-01 administration, compared to placebo, with no serious adverse events observed. About ZT-01 ZT-01 is designed to prevent potentially dangerous low blood glucose by restoring the body's ability to counterregulate hypoglycemia. In people without diabetes, α-cells secrete glucagon that signals the body to release its own glucose stores to prevent or reverse hypoglycemia. However, in people with insulin-dependent diabetes – including those with T1D and insulin-dependent Type 2 diabetes – evidence suggests that elevated secretion of pancreatic somatostatin suppresses glucagon release from α-cells. Zucara has demonstrated that, in people with T1D, the glucagon response can be increased with ZT-01, a first-in-class SST receptor 2 antagonist. About Zucara Therapeutics Inc. Zucara Therapeutics is developing ZT-01, a first-in-class, once-daily therapeutic to prevent hypoglycemia in people with T1D and insulin-dependent Type 2 diabetes. ZT-01 is designed to inhibit somatostatin, a pancreatic hormone that impairs the glucagon response to hypoglycemia in people with these conditions. ZT-01 is designed to restore glucagon secretion to prevent hypoglycemia, which could dramatically change diabetes disease management and improve both patient health and quality of life. For more information, visit .

Phase 2Phase 1Clinical Result

14 Aug 2023

·www.pharmaceutical-technology.com

vTv announces Phase III plans for type 1 diabetes drug cadisegliatin

Phalguni Deswal @Phalguni_GD Image Credit: Shutterstock/antoniodiaz vTv Therapeutics plans to initiate a Phase III clinical trial for cadisegliatin for treating type 1 diabetes (T1D) by the end of 2023 before filing for marketing approval with the US Food and Drug Administration (FDA). Cadisegliatin is a liver-selective glucokinase activator that is used as an adjunct therapy with insulin. It received a breakthrough therapy designation (BTD) based on its Phase II trial (NCT03335371) , which showed a 40% decrease in the frequency of severe and symptomatic hypoglycaemic events along with a decrease in serum and urine ketone events in the treatment group. Recommended Reports Reports LOA and PTSR Model - Siplizumab in Type 1 Diabetes (Juvenile Diabetes) GlobalData Reports LOA and PTSR Model - Golimumab in Type 1 Diabetes (Juvenile Diabetes) GlobalData View all Companies Intelligence vTv Therapeutics Inc Cantex Pharmaceuticals Inc VTV View all The Phase III trial will assess the reduction in the number of hypoglycaemic events with cadisegliatin, compared to placebo. This primary endpoint for the trial is recommended by the FDA as part of the approval data for T1D drugs. vTv plans to expand the drug indications for cadisegliatin to potentially include type 2 diabetes, chronic obstructive pulmonary disease, renal disease, primary mitochondrial myopathy, glioblastoma and other cancer, and related conditions. Hypoglycaemia is a significant concern for patients with T1D, as insulin treatment causes hypoglycaemia in these patients. Other drugs currently in development for treating insulin-induced hypoglycaemia include Zucara Therapeutics’ ZT-01 . vTv’s other drug azeliragon is currently in Phase II/III of development for triple-negative breast cancer by its partner, Cantex Pharmaceuticals. Azeliragon is a receptor for advanced glycation end products (RAGE) inhibitor which is being investigated for multiple indications including Alzheimer’s disease , Covid-19 complications, brain metastasis, glioblastoma, inflammatory lung disease, and other cancer indications. The company’s cash reserves stand at $12.6m as of 30 June 2023. vTv now has until 18 December 2023 to comply with Nasdaq’s Minimum Bid Requirement, which requires a company’s ordinary shares to have a value of at least $1 for a minimum of ten business days. The value of vTv’s share stands at $0.72, as of the market close on 11 August, with a market cap of $58.75m.

Phase 2Breakthrough TherapyPhase 3Clinical Result

15 Jun 2023

·www.prnewswire.com

Zucara Therapeutics Announces Additional Funding from JDRF to Support ZT-01 Phase 2 Study

- Award to provide US$2 million to support Zucara's planned Phase 2a ZONE trial, with first patient dosing expected in Q3 2023 - TORONTO, June 15, 2023 /PRNewswire/ - Zucara Therapeutics Inc., ("Zucara" or the "Company") a diabetes-focused life sciences company developing the first once-daily therapeutic to prevent hypoglycemia (low blood glucose levels) in people with diabetes, today announced additional funding from JDRF, the leading global Type 1 diabetes ("T1D") research and advocacy organization. Through its Industry Discovery & Development Partnerships ("IDDP") program, JDRF will provide US$2 million in funding to support Zucara's planned Phase 2a study of the effect of ZT-01 On Nocturnal hypoglycemia Events in Type 1 diabetes mellitus ("ZONE"). Zucara expects to begin patient dosing in the third quarter of 2023. "JDRF has been a long-time partner of Zucara, supporting the development of ZT-01 from early discovery studies to this planned Phase 2 study soon underway," said Richard Liggins PhD, Zucara Therapeutics' Chief Scientific Officer. "We are grateful for JDRF's ongoing support. This funding underscores JDRF's prioritization of advancing adjunctive therapies to insulin reflecting a continuing unmet need for T1D patients. We are hopeful that the ZONE study will demonstrate that ZT-01 can prevent potentially dangerous and disruptive low blood glucose levels overnight, and lead to the first therapeutic to treat this unintended consequence of insulin therapy." "Hypoglycemia remains a significant clinical challenge for people with T1D. Moreover, fear of hypoglycemia has great impact on quality of life for people with T1D and their caregivers. Therapies to prevent recurrent hypoglycemia, particularly overnight, are greatly needed," said Courtney Ackeifi, PhD, senior scientist at JDRF. "JDRF is excited to support Zucara's development of a novel therapy with the potential to protect against nocturnal hypoglycemia and help people with T1D achieve better glucose control." About ZT-01 ZT-01 is designed to prevent potentially dangerous low blood glucose levels by restoring the body's ability to counter-regulate hypoglycemia. In people without diabetes, α-cells secrete glucagon that signals the body to release its own glucose stores, thus preventing hypoglycemia. However, in people with insulin-dependent diabetes – including those with T1D and insulin-dependent Type 2 diabetes – evidence suggests that elevated secretion of pancreatic somatostatin ("SST") suppresses glucagon release from α-cells. Zucara has demonstrated that, in people with T1D, the glucagon response can be increased with ZT-01, a first-in-class SST receptor 2 antagonist. About Zucara Therapeutics Inc. Zucara Therapeutics is developing ZT-01, a first-in-class, once-daily therapeutic to prevent hypoglycemia in people with T1D and insulin-dependent Type 2 diabetes. ZT-01 is designed to inhibit somatostatin, a pancreatic hormone that impairs the glucagon response to hypoglycemia in people with these conditions. ZT-01 is designed to restore glucagon secretion to prevent hypoglycemia, which could dramatically change diabetes disease management and improve both patient health and quality of life. For more information, visit . About JDRF JDRF's mission is to accelerate life-changing breakthroughs to cure, prevent and treat T1D and its complications. To accomplish this, JDRF has invested more than $2.5 billion in research funding since our inception. We are an organization built on a grassroots model of people connecting in their local communities, collaborating regionally and globally for efficiency and broader fundraising impact, and uniting on a global stage to pool resources, passion, and energy. We collaborate with academic institutions, policymakers, and corporate and industry partners to develop and deliver a pipeline of innovative therapies to people living with T1D. Our staff and volunteers throughout the United States and our five international affiliates are dedicated to advocacy, community engagement, and our vision of a world without T1D. For more information, please visit jdrf.org or follow us on Twitter (@JDRF), Facebook (@myjdrf), and Instagram (@jdrfhq). About Type 1 Diabetes (T1D) T1D is an autoimmune condition that causes the pancreas to make very little insulin or none at all. This leads to dependence on insulin therapy and the risk of short or long-term complications, which can include highs and lows in blood sugar; damage to the kidneys, eyes, nerves, and heart; and even death if left untreated. Globally, it impacts nearly 9 million people. Many believe T1D is only diagnosed in childhood and adolescence, but diagnosis in adulthood is common and accounts for nearly 50% of all T1D diagnoses. The onset of T1D has nothing to do with diet or lifestyle. While its causes are not yet entirely understood, scientists believe that both genetic factors and environmental triggers are involved. There is currently no cure for T1D. SOURCE Zucara Therapeutics Inc.

Phase 2

100 Deals associated with ZT-01

R&D Status

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Diabetes Mellitus, Type 1	Phase 2	US	Zucara Therapeutics, Inc.Startup	28 Jul 2023
Diabetes Mellitus, Type 1	Phase 2	CA	Zucara Therapeutics, Inc.Startup	28 Jul 2023
Hypoglycemia	Phase 2	US	Zucara Therapeutics, Inc.Startup	28 Jul 2023
Hypoglycemia	Phase 2	CA	Zucara Therapeutics, Inc.Startup	28 Jul 2023
Diabetes Mellitus, Type 2	Preclinical	CA	New York University	02 Nov 2020
Diabetes Mellitus, Type 2	Preclinical	CA	Zucara Therapeutics, Inc.Startup	02 Nov 2020

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05007977 (OP 11, EASD2023)	Phase 1	Diabetes Mellitus, Type 1	23	ZT-01 3 mg	gbfqtnbmye(aujgcqumag) = No SAEs were reported rprmnmqxxx (fkezofrako ) View more	Positive	03 Oct 2023
				ZT-01 20 mg
ADA2023	Not Applicable	Diabetes Mellitus, Type 1	23	ZT-01 3 mg	fsykxvgwzv(krexjlomok) = wzatojrdex rvfpqfcxrc (hefwkmpzjg )	-	20 Jun 2023
ADA2020	Not Applicable	-	-	ZT-01	jblhyizhmi(xhljvwkpkq) = dopvqynyau pjqawbvdwn (xkvlwdoejr )	-	01 Jun 2020
ADA2020	Not Applicable	-	-	ZT-01	tdwrgmpxwl(unkutbwtve) = rultssuyvh hfjeajnvri (vwlzqoltws )	-	01 Jun 2020
				PRL-2903	tdwrgmpxwl(unkutbwtve) = kmqlbipvpl hfjeajnvri (vwlzqoltws )

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ZT-01

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