A randomized, single-centre, double-blind, placebo-controlled proof-of-concept parallel group clinical trial to investigate the efficacy, safety and tolerability of weekly subcutaneous (SC) dosing of CK-0045 in participants with overweight / obesity and Type 2 diabetes - CK-0045_CS02

开始日期2024-09-16

申办/合作机构

CytoKi Pharma ApS初创企业

NCT06611930 / Recruiting临床2期

A Randomized, Single-centre, Double-blind, Placebo-controlled Proof-of-concept Parallel Group Clinical Trial to Investigate the Efficacy, Safety and Tolerability of Weekly Subcutaneous Dosing of CK-0045 in Participants With Overweight/Obesity and Type 2 Diabetes

The goal of this clinical trial is to learn if treatment with CK-0045 improves blood sugar control after a meal in participants with type 2 diabetes mellitus (T2DM) and overweight/obesity. It also aims to learn if CK-0045 can reduce body weight in these patients.
The main question it aims to answer is:
• Does 16 weeks of treatment with CK-0045 improve blood sugar control after a meal in participants with overweight or obesity and T2DM? Researchers will compare two dose levels of CK-0045 to a placebo arm (a look-alike substance that contains no drug) to see if CK-0045 improves blood sugar control.
Participants will:
* Have CK-0045 or placebo injected subcutaneously (under the skin) once weekly over a period of 16 weeks.
* Visit the clinic 24 times and stay overnight at 2 of the visits.
* During the visits blood samples will be collected and several other assessments/examinations will be performed to learn about the effects (and potential side effects) of CK-0045.

开始日期2024-09-16

申办/合作机构

CytoKi Pharma ApS初创企业

[+1]

NCT05712876 / Completed临床1期

A Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Investigate Safety, Tolerability, and Pharmacokinetics of CK-0045 Following Subcutaneous Administration in Healthy Participants and Otherwise Healthy Participants With Obesity

The goal of this clinical trial is to assess the safety, tolerability and blood levels following a single dose or after multiple doses of CK-0045 given subcutaneously to healthy participants or otherwise healthy participants with obesity. 76 participants will receive CK-0045 or matching placebo at different escalating doses in 2 study parts: 40 healthy participants will receive a single dose and 36 otherwise healthy participants with obesity will receive 6 doses one week apart.

开始日期2022-12-26

申办/合作机构

CytoKi Pharma ApS初创企业

[+1]

100 项与 CK-0045 相关的临床结果

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100 项与 CK-0045 相关的转化医学

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100 项与 CK-0045 相关的专利（医药）

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项与 CK-0045 相关的新闻（医药）

2024-11-04

·PRNewswire

Cytoki Pharma Announces First Patient Dosed in Phase 2 Study of CK-0045 in Obesity and Type 2 Diabetes

The Phase 2 study will evaluate the efficacy, safety and tolerability of the company's lead lipidated IL-22 analogue, CK-0045, in patients with obesity and type 2 diabetes COPENHAGEN, Denmark, Nov. 4, 2024 /PRNewswire/ -- Cytoki Pharma, ApS (Cytoki), a clinical-stage biotechnology company pioneering a new class of medicines that harness IL-22 biology to drive improved outcomes for metabolic disease, today announced the first patient has received CK-0045 in a Phase 2 proof-of-concept trial evaluating efficacy, safety and tolerability in individuals with obesity and type 2 diabetes. "A leading public health priority, obesity and diabetes cumulatively impact more than one billion individuals worldwide. While the emergence of incretin-based medicines has provided new treatment options, there remains a demand for novel approaches that offer additional cardiometabolic benefits beyond body weight reduction alone," said Anne Louise Kjølbye, Ph.D., MBA, CDO at Cytoki. "CK-0045 offers a novel approach to metabolic disease treatment with the potential to prolong healthy lifespan through muscle-sparing weight loss accompanied by broader health benefits." CK-0045 is an IL-22 analogue that leverages commercially proven lipidation technology to extend circulation time in the body, enabling subcutaneous delivery and offering first-in-class potential to address obesity and type 2 diabetes. Results from the Phase 1 clinical study of CK-0045 in healthy volunteers confirmed target engagement and exposure-dependent reductions in body mass, alongside improvements in low-density lipoprotein (LDL) cholesterol, blood insulin levels, and insulin resistance. These results, combined with a favorable safety profile, support further clinical advancement of CK-0045. "Encouraging results from the Phase 1 study of CK-0045 demonstrate the potential of its unique IL-22 based mechanism of action as a powerful new therapeutic approach to address obesity and type 2 diabetes," said Dr Carel le Roux, Professor of Experimental Pathology, University College Dublin. "We eagerly anticipate Cytoki's progress as it continues clinical evaluation of CK-0045 and develops its broader IL-22-derived pipeline to deliver novel treatments for metabolic disease." The 16-week randomized, double-blind, placebo-controlled Phase 2 study (NCT06611930) will evaluate the efficacy, safety and tolerability of two doses of CK-0045, administered subcutaneously once a week, in 90 patients with obesity and type 2 diabetes. The outcomes investigated in the study reflect the wide range of metabolic benefits of IL-22 modulation and include amongst others weight loss, change in HbA1c, insulin sensitivity measurements, and lipid levels. Results of the study are anticipated in the first half of 2026. Additionally, Cytoki continues to advance a robust portfolio of IL-22-based assets targeting high unmet need in metabolic disease as well as inflammatory bowel disease. About CK-0045 CK-0045 is a long-acting analogue of interleukin-22 (IL-22), an atypical, non-immunomodulatory cytokine that selectively targets epithelial cells. In-licensed from Novo Nordisk A/S, CK-0045 incorporates validated technology to optimize the pharmacologic properties of the endogenous IL-22 protein to create a differentiated, first-in-class therapy with potential to address a broad range of metabolic diseases, including obesity and type 2 diabetes, and conditions characterized by epithelial injury, such as inflammatory bowel disease. CK-0045 has been evaluated in a randomized, double-blind, placebo-controlled Phase 1 study designed to investigate its safety, tolerability, and pharmacokinetics in healthy individuals with and without obesity (NCT05712876). CK-0045 is currently being investigated in a Phase 2 clinical trial for patients with type 2 diabetes and overweight / obesity (NCT06611930). About Cytoki Pharma Cytoki Pharma is a clinical-stage biotechnology company pioneering a new class of medicines that harness IL-22 biology to drive improved outcomes for cardiometabolic disease. Cytoki's lead program, CK-0045, is a lipidated IL-22 analogue that is currently being evaluated in a Phase 2 clinical study. The company is also advancing a broader portfolio of preclinical IL-22-based assets for the treatment of metabolic disease and inflammatory bowel disease. Cytoki was founded in 2019 and is led by a team of pharma industry veterans with deep expertise in the discovery and clinical development of novel drugs. Please visit or follow us on LinkedIn for additional details. Media Contact Lia Dangelico [email protected] +1 540-303-0180 SOURCE Cytoki Pharma WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

临床2期临床1期

2024-07-23

·Firstwordpharma

Cytoki’s IL-22 analogue shows early promise for obesity and diabetes

Cytoki Pharma on Tuesday reported promising early data for its investigational lipidated IL-22 analogue CK-0045 in a Phase I study of 76 healthy participants and otherwise healthy participants with obesity, highlighting improvements on key cardiometabolic parameters."We believe CK-0045 offers a differentiated opportunity to address obesity and type 2 diabetes, either as monotherapy or in combination,” said Rasmus Jørgensen, chief executive of Cytoki. The company noted the data were adequate to support the drug’s advancement into mid-stage testing, which is likely to commence in the second half of the year.CK-0045 is an analogue of a non-immunomodulatory cytokine IL-22, selectively targeting epithelial cells in the gut and liver. According to the biotech, the drug’s “unique mechanism of action” mimicking endogenous IL-22 could potentially help treat various metabolic and inflammatory conditions. Preclinical data from mice studies have earlier shown weight loss and improved glucose homeostasis.Phase I findings established target engagement through liver and gut-derived biomarkers, while the pharmacokinetic data indicated the feasibility of once-weekly subcutaneous dosing. Additionally, exposure-dependent reductions in body mass and improvements on low-density lipoprotein cholesterol, insulin levels, and insulin resistance were observed, especially in participants with reduced insulin sensitivity. Moreover, CK-0045 had a favourable safety and tolerability profile, with no significant gastrointestinal side effects.Cytoki was founded in 2019 by Jørgensen, who previously headed research at Novo Nordisk. CK-0045 was subsequently in-licensed from Novo and positioned as the company’s lead asset.

临床1期临床结果

2024-07-23

·PRNewswire

Cytoki Pharma Announces Positive Phase 1 Data Showing Potential of CK-0045 to Improve Cardiometabolic Risk Factors

CK-0045 induced exposure-dependent reductions in body weight and improvement of key metabolic parameters in participants with obesity Data support advancement of CK-0045 into Phase 2 proof-of-concept studies in individuals with type 2 diabetes and/or obesity COPENHAGEN, Denmark, July 23, 2024 /PRNewswire/ -- Cytoki Pharma, ApS (Cytoki), a clinical-stage biotechnology company pioneering a new class of medicines that harness IL-22 biology to drive improved outcomes for metabolic disease, today announced positive data from a Phase 1 study evaluating the safety, tolerability, and pharmacokinetics of CK-0045, its lead lipidated IL-22 candidate, in healthy participants and otherwise healthy participants with obesity. The data signal the effect of CK-0045 across several key metabolic parameters including body weight, cholesterol, blood glucose levels, and insulin sensitivity. "As the obesity treatment landscape continues to evolve, there remains a need for approaches that drive lasting disease modification through healthy weight loss and broader, deeper weight loss-independent metabolic effects," said Rasmus Jorgensen, Ph.D., Founder and CEO of Cytoki Pharma. "We believe CK-0045 offers a differentiated opportunity to address obesity and type 2 diabetes, either as monotherapy or in combination with other clinical approaches and are encouraged by these first data supporting CK-0045's unique mechanism of action." IL-22 is a non-immunomodulatory cytokine that selectively targets epithelial tissues such as the gut and liver. Previously reported preclinical data demonstrate the potential of lipidated IL-22 to reduce body weight and improve glucose homeostasis in mice through a novel mode-of-action. Results from the Phase 1 study signal successful translation of the preclinical findings to humans, with confirmed target engagement based on liver and gut-derived biomarkers. Pharmacokinetic data confirm feasibility of once weekly subcutaneous dosing. CK-0045 induced exposure-dependent reductions in body mass that were complemented by beneficial reductions in low-density lipoprotein cholesterol, blood insulin concentration, and insulin resistance—particularly in participants with reduced insulin sensitivity. CK-0045 was safe and tolerated across the multiple ascending dose portion of the study, with all but one participant having completed dosing. The most commonly occurring side effects were mild skin reactions and a notable absence of substantial gastrointestinal effects was observed. The available clinical data support advancement of CK-0045 into Phase 2 proof-of-concept studies in individuals with obesity and type 2 diabetes to further assess the clinical relevance of observed effects. Initiation of the Phase 2 is anticipated in the second half of 2024. About CK-0045 CK-0045 is a long-acting analogue of interleukin-22 (IL-22), an atypical, non-immunomodulatory cytokine that selectively targets epithelial cells. In-licensed from Novo Nordisk A/S, CK-0045 incorporates validated technology to optimize the pharmacologic properties of the endogenous IL-22 protein to create a differentiated, first-in-class therapy with potential to address a broad range of metabolic diseases, including obesity and type 2 diabetes, and conditions characterized by epithelial injury, such as inflammatory bowel disease. CK-0045 has been evaluated in a randomized, double-blind, placebo-controlled Phase 1 study designed to investigate its safety, tolerability, and pharmacokinetics in healthy individuals with and without obesity (NCT05712876). CK-0045 is expected to enter Phase 2 studies in the second half of 2024. About Cytoki Pharma Cytoki Pharma is a clinical-stage biotechnology company pioneering a new class of medicines that harness IL-22 biology to drive improved outcomes for cardiometabolic disease. Cytoki's lead program, CK-0045, is a lipidated IL-22 analogue that has been evaluated in a Phase 1 clinical study and is expected to enter Phase 2 clinical studies in the second half of 2024. The lead compound is selected from a full program of therapeutic IL-22 variants based on an exclusive license from Novo Nordisk A/S. The company is also advancing a broader portfolio of preclinical IL-22-based assets for the treatment of metabolic disease and inflammatory bowel disease. Cytoki was founded in 2019 and is led by a team of pharma industry veterans with deep expertise in the discovery and clinical development of novel drugs. Please visit or follow us on LinkedIn for additional details. SOURCE Cytoki Pharma

临床1期引进/卖出临床结果临床2期

100 项与 CK-0045 相关的药物交易

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
2型糖尿病	临床2期	德国	CytoKi Pharma ApS初创企业	2024-09-16
肥胖	临床2期	德国	CytoKi Pharma ApS初创企业	2024-09-16
糖尿病	临床前	丹麦	CytoKi Pharma ApS初创企业	2023-10-16

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT05712876 (PRNewswire) 人工标引	临床1期	肥胖	-	CK-0045	壓構壓獵衊製鏇遞鏇淵(糧繭網觸築鬱蓋壓膚簾) = CK-0045 was safe and tolerated across the multiple ascending dose portion of the study, with all but one participant having completed dosing. The most commonly occurring side effects were mild skin reactions and a notable absence of substantial gastrointestinal effects was observed. 廠憲淵築憲遞憲築齋餘 (壓憲淵餘遞夢積築廠獵 )	积极	2024-07-23
				Placebo