A Phase 2 Randomized, Double-Blind, Placebo-Controlled, 13-week Study of VK2735 for Weight Management in Subjects Who Are Obese, or Overweight With at Least One Weight-related Comorbid Condition

This is a phase 2, 13-week randomized, double-blind, placebo-controlled, parallel arm study that will evaluate the safety, tolerability, weight loss efficacy, pharmacodynamic effects, and pharmacokinetics of VK2735 in adults who are obese (BMI ≥30 kg/m2) or who are overweight (BMI ≥27 kg/m2) with at least one weight-related co-morbid condition.
VK2735 or matched placebo will be administered once weekly.

开始日期2023-08-31

申办/合作机构

Viking Therapeutics, Inc.

NCT05203237 / Recruiting临床1期

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of VK2735, a Dual Glucagon-like Peptide-1 and Gastric Inhibitory Polypeptide Receptor Agonist, in Healthy Adults and Otherwise Healthy Adults Who Have an Increased Body Mass Index

This is a Phase 1, randomized, double-blind, placebo-controlled single and multiple ascending dose study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of VK2735 in healthy adults and otherwise healthy adults who have an increased body mass index (BMI).

开始日期2021-12-14

申办/合作机构

Viking Therapeutics, Inc.

ISRCTN47896018 / Completed临床1期

A Phase I, randomized, double-blind, placebo-controlled, single and multiple ascending dose study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of VK2735, a dual glucagon-like peptide-1 and gastric inhibitory polypeptide receptor agonist, in healthy adults and otherwise healthy adults who have an increased body mass index

开始日期2021-12-01

申办/合作机构

Viking Therapeutics, Inc.

100 项与 VK-2735 相关的临床结果

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100 项与 VK-2735 相关的转化医学

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100 项与 VK-2735 相关的专利（医药）

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153

项与 VK-2735 相关的新闻（医药）

2024-10-28

·PRNewswire

Viking Therapeutics to Highlight Clinical Data from VK2735 Obesity Program in Presentations at ObesityWeek® 2024

Results from VENTURE Phase 2 Study of Subcutaneous VK2735 in Obese Patients and Phase 1 Trial of Oral VK2735 in Healthy Subjects to be Presented SAN DIEGO, Oct. 28, 2024 /PRNewswire/ -- Viking Therapeutics, Inc. ("Viking") (NASDAQ: VKTX), a clinical-stage biopharmaceutical company focused on the development of novel therapies for metabolic and endocrine disorders, today announced that clinical data from the company's VK2735 obesity program will be highlighted in two poster presentations at ObesityWeek® 2024, the annual meeting of the Obesity Society. VK2735 is a dual agonist of the glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptors being developed for the potential treatment of various metabolic disorders. Viking is evaluating both subcutaneous and oral formulations of VK2735 in clinical trials. ObesityWeek 2024 is being held November 3-6, 2024, in San Antonio, Texas. One presentation will summarize results from the company's Phase 2 VENTURE clinical trial, which evaluated 13 weeks of weekly treatment with a subcutaneous formulation of VK2735 in obese subjects. A second presentation will highlight results from the company's Phase 1 multiple ascending dose (MAD) clinical trial of an oral tablet formulation of VK2735 dosed daily for 28 days. Details of the presentations are as follows: Poster Presentation #018: Title: Results from the 13-Week VENTURE Phase 2 Study of the GLP-1/GIP Co-Agonist VK2735 in Obese Subjects Presenting Author: Joel Neutel, M.D., Orange County Research Center Date/Time: Sunday, November 3, 2024, 7:30 – 8:30 p.m. Central Time Location: Exhibit Hall 4B of the Henry B. Gonzalez Convention Center Poster Presentation #017: Title: First-in-Human Study of an Oral Formulation of the GLP-1/GIP Co-Agonist VK2735 in Healthy Adults Presenting Author: Joel Neutel, M.D., Orange County Research Center Date/Time: Sunday, November 3, 2024, 7:30 – 8:30 p.m. Central Time Location: Exhibit Hall 4B of the Henry B. Gonzalez Convention Center About GLP-1 and Dual GLP-1/GIP Agonists Activation of the glucagon-like peptide 1 (GLP-1) receptor has been shown to decrease glucose, reduce appetite, lower body weight, and improve insulin sensitivity in patients with type 2 diabetes, obesity, or both. Semaglutide is a GLP-1 receptor agonist that has been approved by the U.S. Food and Drug Administration and is currently marketed in various dosage strengths and forms as Ozempic®, Rybelsus®, and Wegovy®. More recently, research efforts have explored the potential co-activation of the glucose-dependent insulinotropic peptide (GIP) receptor as a means of enhancing the therapeutic benefits of GLP-1 receptor activation. Tirzepatide is a dual GLP-1/GIP receptor agonist that has been approved by the U.S. Food and Drug Administration and is currently marketed in various dosage strengths and forms as Mounjaro® and Zepbound®. About Viking Therapeutics, Inc. Viking Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on the development of novel first-in-class or best-in-class therapies for the treatment of metabolic and endocrine disorders, with three compounds currently in clinical trials. Viking's research and development activities leverage its expertise in metabolism to develop innovative therapeutics designed to improve patients' lives. Viking's clinical programs include VK2735, a novel dual agonist of the glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptors for the potential treatment of various metabolic disorders. Data from a Phase 1 and a Phase 2 trial evaluating VK2735 (dosed subcutaneously) for metabolic disorders demonstrated an encouraging safety and tolerability profile as well as positive signs of clinical benefit. Concurrently, the company is evaluating an oral formulation of VK2735 in a Phase 1 trial. Viking is also developing VK2809, a novel, orally available, small molecule selective thyroid hormone receptor beta agonist for the treatment of lipid and metabolic disorders. The compound successfully achieved both the primary and secondary endpoints in a recently completed Phase 2b study for the treatment of biopsy-confirmed non-alcoholic steatohepatitis (NASH) and fibrosis. In a Phase 2a trial for the treatment of non-alcoholic fatty liver disease (NAFLD) and elevated LDL-C, patients who received VK2809 demonstrated statistically significant reductions in LDL-C and liver fat content compared with patients who received placebo. The company's newest program is evaluating a series of internally developed dual amylin and calcitonin receptor agonists (or DACRAs) for the treatment of obesity and other metabolic disorders. In the rare disease space, Viking is developing VK0214, a novel, orally available, small molecule selective thyroid hormone receptor beta agonist for the potential treatment of X-linked adrenoleukodystrophy (X-ALD). In a Phase 1b clinical trial in patients with the adrenomyeloneuropathy (AMN) form of X-ALD, VK0214 was shown to be safe and well-tolerated, while driving significant reductions in plasma levels of very long-chain fatty acids (VLCFAs) and other lipids, as compared to placebo. For more information about Viking Therapeutics, please visit . SOURCE Viking Therapeutics, Inc. 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期临床结果临床1期上市批准

2024-10-24

·Endpoints

Bayer, Dewpoint to work on heart drug; Viking’s obesity manufacturing plans

Plus, news about Interius BioTherapeutics, Hope Medicine, PMV Pharmaceuticals, Epitopea, Alyssum Therapeutics and a new dementia trial accelerator in the UK: Bayer exercises option to develop heart drug with Dewpoint Therapeutics : The companies, which first teamed up in 2019, now plan to develop a therapy for dilated cardiomyopathy, a heart muscle disease. Bayer is paying $424 million in upfront and milestone payments. — Jaimy Lee Viking Therapeutics is already thinking about an obesity launch: The company plans to meet with the FDA before the end of the year to discuss Phase 3 plans for its subcutaneous GLP-1/GIP receptor agonist, VK2735, according to remarks made by CEO Brian Lian on Wednesday’s earnings call. Viking is already in conversation with manufacturers, and Lian said he’s confident the company will be able to supply “a blockbuster-sized product at the appropriate time.” Viking is also launching a Phase 2 trial this quarter for an oral version of VK2735. Lian described the experimental oral medicine as more of an “add-on” to the portfolio, while the subcutaneous version would be the “anchor piece.” — Nicole DeFeudis Interius BioTherapeutics doses first ever patient with in vivo CAR-T: The biotech gave an in vivo CAR-T therapy to a patient enrolled in a Phase 1 study of INT2104, which it’s developing for B cell cancers. The trial, which is being run in Australia, is the first test of its kind. Umoja Biopharma has said it plans to dose a patient in its US-based study of its own in vivo CAR-T therapy by the end of this year . — Lei Lei Wu Hope Medicine touts interim data for endometriosis treatment: The company’s monoclonal antibody, dubbed HMI-115 , demonstrated statistically significant improvement in endometriosis pain at 12 weeks. The Phase 2 trial enrolled 142 female patients in the US, Poland and China. The mean dysmenorrhea pain score was reduced by 42%, and non-menstrual pelvic pain score was reduced by 50%. Hope CEO Nathan Chen said the company plans to “move quickly” toward global Phase 3 trials. — Katherine Lewin PMV Pharmaceuticals discontinues early-stage cancer trial: Citing toxicities and limited clinical benefit, the company abandoned its Phase 1b study assessing rezatapopt and Merck’s Keytruda. It had been testing the combo in patients with advanced solid tumors harboring a TP53 Y220C mutation. PMV said enrollment for a Phase 2 trial evaluating rezatapopt as a monotherapy for patients with TP53 Y220C and KRAS wild-type advanced solid tumors is still on track. — Katherine Lewin Epitopea closes $31M pre-Series A: With today’s round, the cancer biotech has raised more than $45 million. The funds are set to go toward its preclinical discovery work in solid tumors and clinical development plans for its RNA-based immunotherapies. — Katherine Lewin Alyssum Therapeutics emerges from stealth with $26M Series A: The Cambridge, MA-based biotech’s lead asset is AT-1965, a clinical-stage small molecule CMTR2 inhibitor. This round was led by co-founder Patrick Soon-Shiong and Accel, Famy and Navam Capital. — Katherine Lewin UK government pours £20M into dementia trial accelerator: The new initiative aims to increase the number of participants in late-stage dementia studies to the tens of thousands and “address pharma-identified roadblocks” to running the trials. The Dementia Trials Accelerator’s objectives include creating a biomarker toolbox and extending trial enrollment to community settings. — Ayisha Sharma

临床2期临床结果免疫疗法临床1期临床3期

2024-10-24

·BioSpace

Viking to Accelerate Development of Obesity Drug With Two Q4 Catalysts

Nicole Bean for BioSpace Following an end-of-Phase II meeting with the FDA in the fourth quarter, Viking Therapeutics plans to push its subcutaneous obesity therapy VK2735 into late-stage development and to start a Phase II trial for an oral formulation. Viking Therapeutics on Wednesday unveiled plans to ramp up the development of its investigational obesity therapy VK2735, with two key upcoming events in the fourth quarter of 2024. Prior to the end of the year, the company expects an end-of-Phase II meeting with the FDA for its subcutaneous formulation of VK2735, after which it plans to push the drug candidate into late-stage development for obesity. Viking will reveal more details about the Phase III program’s design and timeline after the regulatory meeting. Also in Q4, Viking will start its Phase II trial for the oral formulation of VK2735, which it is advancing alongside the more mature subcutaneous version. Specifics of the mid-stage study were sparse, with the company only revealing that it will run for 13 weeks. Viking CEO Brian Lian in an investor call on Wednesday promised to provide more details regarding the study’s design “as we get closer to trial initiation.” “We are proud of the clinical progress we’ve made this year,” Lian said during the call, referring to the strong data the biotech has generated for VK2735. In Q1, Viking released a topline readout for the Phase II VENTURE study, touting a 9.1% drop in body weight at 13 weeks in patients treated with the 2.5-mg subcutaneous VK-2735. Placebo counterparts, on the other hand, lost only 1.7% of their body weight at this time point. At a 15-mg dose, VK-2735 elicited nearly 15% weight loss. A month later, Viking also announced that oral VK2735 at a 40-mg dose resulted in a 3.3% reduction in mean body weight versus placebo, an effect that was statistically significant. “The first three quarters of 2024 have been data-rich for Viking,” Lian said, noting that aside from its promising efficacy, VK2735 also has a strong safety profile. Most treatment-emergent adverse events were mild or moderate and arose early in the treatment course. A majority of the side effects were gastrointestinal in nature, which is common for the GLP-1 drug class. Analysts were positive about Viking’s update on Wednesday. Truist Securities analyst Joon Lee in an investor note said that oral VK2735 “could be the best oral GLP1 yet, on efficacy and tolerability,” noting that the company’s VK2735 franchise appears to have an “excellent safety profile,” especially since even a 100-mg dose of the oral formulation did not trigger a stop signal from an independent data monitoring committee. Given the pharmacokinetic pro subcutaneous VK2735, Viking is also exploring a monthly dosing regimen for the therapy, which William Blair analyst Andy Hsieh wrote in an investor note “could provide a key differentiator from competitive programs,” particularly given ongoing concerns about supply and production. Viking also released Q3 results on Wednesday, reporting a net loss of nearly $25 million, driven by more aggressive R&D activities in the quarter. Still, the company expects to have enough money to fund the development of its programs, especially VK2735. “With $930 million in cash and equivalents at the end of the third quarter, we believe we have the financial resources required to reach key clinical milestones for each of our programs, and we look forward to reporting further progress in the quarters ahead,” Lian said.

临床2期临床结果财报

100 项与 VK-2735 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
肥胖	临床2期	美国	Viking Therapeutics, Inc.	2023-08-31
代谢性疾病	临床1期	美国	Viking Therapeutics, Inc.	2022-01-10
非酒精性脂肪性肝炎	临床1期	澳大利亚	Viking Therapeutics, Inc.	2021-12-14

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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


NCT05203237 (PRNewswire) 人工标引	临床1期	体重下降	45	VK2735 2.5 mg	(齋壓願壓廠膚顧衊願繭) = mild or moderate, with the majority (76%) reported as mild. 廠積積願願餘鏇鬱淵遞 (夢窪鬱夢糧窪獵齋遞餘 )	积极	2024-03-26
				VK2735 5 mg
NCT06068946 (VENTURE, Corporate Publications) 人工标引	临床2期	肥胖	-	VK2735 2.5 mg	(夢壓淵衊獵襯齋餘觸醖) = 鏇網艱鑰製膚鬱選廠遞廠艱選糧糧窪範築艱壓 (鑰網鏇糧網艱鏇淵襯製 ) 达到更多	积极	2024-02-27
				VK2735 5 mg	(夢壓淵衊獵襯齋餘觸醖) = 鏇願艱範網選鑰襯餘夢廠艱選糧糧窪範築艱壓 (鑰網鏇糧網艱鏇淵襯製 ) 达到更多