A Phase 3 Randomized, Double-Blind, Placebo-Controlled, 78-Week Efficacy and Safety Study of VK2735 Administered Subcutaneously for Weight Management in Participants With Type 2 Diabetes Who Are Obese, or Overweight

This is a phase 3, multicenter, 78-week randomized, double-blind, placebo-controlled, parallel arm study that will evaluate the weight loss efficacy as well as safety, tolerability, pharmacodynamic effects, and pharmacokinetics of VK2735 in adults with Type 2 Diabetes who are obese or overweight

开始日期2025-06-23

申办/合作机构

Viking Therapeutics, Inc.

NCT07104500

/ Active, not recruiting临床3期

开始日期2025-06-23

申办/合作机构

Viking Therapeutics, Inc.

NCT06828055

/ Completed临床2期

A Phase 2 Randomized, Double-Blind, Placebo-Controlled, 13-week Dose Finding Study of VK2735 Oral Formulation 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 dose-finding study that will evaluate the safety, tolerability, weight loss efficacy, pharmacodynamic effects, and pharmacokinetics of VK2735 Oral Formulation 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 daily.

开始日期2024-12-18

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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项与 VK-2735 相关的文献（医药）

2026-03-01·Obesity

Weekly Subcutaneous VK2735 , a GIP / GLP ‐1 Receptor Dual Agonist, for Weight Management: Phase 2, Randomized, 13‐Week VENTURE Study

Article

作者: Ji, Summer ; Pullman, John ; Freilich, Bradley ; Alkhouri, Naim ; Stubbe, Scott ; Neutel, Joel ; Bays, Harold E. ; Lian, Brian ; Hedges, Parke ; Toth, Phillip

ABSTRACT:

Objective:

This study aimed to determine doses of VK2735, a novel glucagon‐like peptide‐1/glucose‐dependent insulinotropic polypeptide (GLP‐1/GIP) receptor dual agonist, that are effective for weight loss over 13 weeks of treatment.

Methods:

VENTURE was a phase 2, randomized, double‐blind, placebo‐controlled, dose‐ranging study of weekly subcutaneous VK2735 in adults with obesity or overweight and ≥ 1 weight‐related comorbidity. Participants with diabetes mellitus were ineligible. The primary endpoint was percent change from baseline in body weight at Week 13. Secondary efficacy endpoints were observed and change from baseline weight loss and the proportion of participants losing ≥ 5% and ≥ 10% of baseline weight.

Results:

Study was conducted between August 2023 and February 2024. Mean weight reduction with active treatment ranged from 9.2 kg (2.5 mg dose) to 14.6 kg (15 mg dose), corresponding to 9.1% and 14.7% weight reductions, respectively; the placebo group had a 1.8 kg (1.7%) reduction. In the active treatment groups, 93% (130/140) of participants had a ≥ 5% weight reduction, compared with 12% (4/34) of participants with placebo treatment. The common adverse events (AEs) were gastrointestinal, which decreased in reported frequency after dose titration to steady state.

Conclusions:

All subcutaneous doses of VK2735 significantly reduced body weight. The AE profile of VK2735 was primarily gastrointestinal, with decreased reported frequency upon continued use.

Trial Registration:

ClinicalTrials.gov identifier NCT06068946 image

284

项与 VK-2735 相关的新闻（医药）

2026-05-05

·PRNewswire

Viking Therapeutics Announces Two Poster Presentations at European Congress on Obesity (ECO) 2026

Poster Presentations Highlight Data from 13-Week Phase 2 VENTURE-Oral Trial of VK2735 and Participant Characteristics from Phase 3 VANQUISH-1 Trial of Subcutaneous VK2735 SAN DIEGO, May 5, 2026 /PRNewswire/ -- Viking Therapeutics, Inc. ("Viking") (NASDAQ: VKTX), a clinical-stage biopharmaceutical company focused on the development of novel therapies for metabolic and endocrine disorders, announced today that it will present two posters on its VK2735 program at the 33rd European Congress on Obesity (ECO) taking place in Istanbul, Türkiye on May 12-15, 2026. VK2735 is a dual agonist of the glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptors that Viking is developing in subcutaneous and oral formulations for the potential treatment of various metabolic disorders, including obesity. At ECO, Viking will present a poster highlighting data from its Phase 2 VENTURE-Oral Dosing trial, focusing on key efficacy and safety endpoints, including weight loss and tolerability during the 13-week study. The second poster will highlight the design and enrollment demographics of the ongoing Phase 3 VANQUISH-1 study of subcutaneous VK2735 in adults with obesity or who are overweight and have at least one weight-related comorbidity. Details of the ECO poster presentations are as follows: Title: Treatment with Oral VK2735 Results in Significant Weight Loss: The Randomized, Placebo-Controlled, Dose-Finding VENTURE-Oral Study Publication Number: PO4.260 Presented by: Karen Modesto, M.D., Vice President, Clinical Development Date/Time: On display May 12-15, with poster networking session on Thursday, May 14, from 18:00 – 19:15 Turkey Time Location: Poster area at Level B5, Istanbul Congress Center Title: VANQUISH-1: Phase 3 Trial With Enrollment of a Diverse Population to Test Efficacy of Subcutaneous VK2735 in Adult Participants with Obesity or Overweight with Weight Related Comorbidities Publication Number: PO4.278 Presented by: Karen Modesto, M.D., Vice President, Clinical Development Date/Time: On display May 12-15, with poster networking session on Thursday, May 14, from 18:00 – 19:15 Turkey Time Location: Poster area at Level B5, Istanbul Congress Center About VK2735 VK2735 is a novel dual agonist of the glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptors in development for the treatment of metabolic disorders, including obesity. The compound is being evaluated in both oral and subcutaneous formulations. 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 . Forward-Looking Statements This press release contains forward-looking statements regarding Viking Therapeutics, Inc., under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, including statements about Viking's expectations regarding its clinical and preclinical development programs, anticipated timing for reporting clinical data and cash resources. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially and adversely and reported results should not be considered as an indication of future performance. These risks and uncertainties include, but are not limited to: risks associated with the success, cost and timing of Viking's product candidate development activities and clinical trials, including those for VK2735, VK0214, VK2809, and the company's other incretin and other receptor agonists; risks that prior clinical and preclinical results may not be replicated; risks regarding regulatory requirements; and other risks that are described in Viking's most recent periodic reports filed with the Securities and Exchange Commission including Viking's Annual Report on Form 10-K for the year ended December 31, 2024, and subsequent Quarterly Reports on Form 10-Q, including the risk factors set forth in those filings. These forward-looking statements speak only as of the date hereof. Viking disclaims any obligation to update these forward-looking statements except as required by law. SOURCE Viking Therapeutics, Inc. 21% more press release views with Request a Demo

临床2期临床结果临床1期上市批准临床3期

2026-05-02

·今日头条

Viking 被 Ligand 告上法庭，两款新药授权遭强制收回

减肥药巨头 Viking 摊上大事了！近日，生物医药圈爆出一起重磅纠纷——Ligand Pharmaceuticals 一纸诉状将昔日合作伙伴 Viking Therapeutics 告上 SEC，指控其"违约"，并单方面宣布收回两款重要新药的全球授权！【合作12年，一朝反目】这场纠纷的根源要追溯到 2014年。当时 Viking 从 Ligand 手中拿下了5个药物项目，其中包括用于治疗脂肪肝（NASH）的 VK2809 和罕见病药物 VK0214。这两款药都曾表现亮眼： - VK2809 在2023年的2期临床中大获成功，Viking 为此支付了 1000万美元里程碑款给 Ligand，并计划推进3期； - VK0214 也在2024年完成了1期临床，数据积极。按协议，如果 VK2809 成功上市，Ligand 能坐享 3.5%-7.5%的销售分成，躺着赚钱。【Viking "移情别恋"，Ligand 怒而掀桌】但事情的转折发生在 Viking 的 2026年Q1财报中——公司只字未提 VK2809 和 VK0214，全部篇幅都在讲其"亲儿子" VK2735（一款GLP-1/GIP双靶点减肥药）。原来，在减肥药市场千亿美金的诱惑下，Viking早已战略"All in"肥胖赛道，把 NASH 和罕见病项目打入了冷宫，甚至公开表示要"寻求外部合作"而非自己开发。 Ligand 一看急了：你这是"放着好项目不开发，专心去追风口"？于是直接发函指控 Viking "未履行商业合理努力开发义务"，宣布 5月4日起终止授权，并要求 Viking 把全球开发权"还回来"，以后 Ligand 自己搞，只给 Viking 留低个位数分成。【Viking 不认账，双方要打官司】 Viking 自然不服，目前正在积极抗辩。Ligand 也放话："我们将坚决维护终止权。" 这场纠纷背后，折射出生物医药行业的残酷现实：在资本和风口面前，曾经的"金童玉女"也能反目成仇。当减肥药 VK2735 的3期临床如火如荼（已入组超4500人），NASH 这种"过气赛道"的项目便成了弃子。但 Ligand 显然不愿看着自己孵化的"蛋"被冷落——与其烂在 Viking 手里，不如收回来自己孵化。【对投资者意味着什么？】 - Viking：短期股价可能承压，但核心资产 VK2735 不受影响，肥胖赛道仍是主逻辑； - Ligand：若能收回 VK2809，或可与其它药企重新谈判，但独自推进3期需要大量资金； - 行业警示：授权协议中的"商业合理努力"条款，可能成为未来更多合作纠纷的导火索。三、参考来源 ▸ Fierce Biotech 原文（2026年5月1日）：https://www.fiercebiotech.com/biotech/ligand-tries-disembark-part-viking-pact-alleging-contract-breach ▸ Ligand SEC 8-K 文件：https://www.sec.gov/cgi-bin/browse-edgar?action=getcompany&CIK=0000886163 ▸ MarketWatch 报道（2026年4月30日）：https://www.marketwatch.com/story/ligand-pharmaceuticals-gives-notice-of-termination-to-viking-therapeutics-over-tr-beta-program-480f5e69 ▸ Viking Q1 2026 财报：https://ir.vikingtherapeutics.com/2026-04-29-Viking-Therapeutics-Reports-First-Quarter-2026-Financial-Results-and-Provides-Corporate-Update ▸ AlphaStreet 深度分析：https://news.alphastreet.com/viking-therapeutics-vk2735-promise-meets-execution-risk/ ⚠️ 免责声明：本文仅供信息参考，不构成投资建议。生物医药投资波动大，请谨慎决策。

临床3期财报临床2期引进/卖出临床1期

2026-05-01

·FierceBiotech

Ligand tries to disembark from part of Viking pact, alleging contract breach

Viking is disputing Ligand\'s move, according to the SEC filing.\n Viking Therapeutics’ collaboration with Ligand Pharmaceuticals has sailed into some trouble, with one of the partners keen to jettison part of the pact. The two companies’ relationship dates back to 2014, when Viking licensed five programs from Ligand. They included a preclinical thyroid hormone receptor-β (TRβ) agonist program for dyslipidemia, dubbed VK0214.Viking has since taken VK0214 into the clinic, where it demonstrated a significant reduction in plasma levels of very long-chain fatty acids in a phase 1 study in 2024.Viking has seen even more success with another TRβ agonist from the pact, called VK2809. Back in 2023, Viking revealed that the therapy had aced a phase 2 study in non-alcoholic steatohepatitis. As a result, Viking handed Ligand a $10 million milestone, as well as announced plans to take the therapy into phase 3 for fatty liver disease.Should Viking take VK2809 to market, Ligand would be entitled to between 3.5% to 7.5% of future worldwide sales, Ligand noted at the time.However, that path to market seems to be less clear these days. While both therapies continue to be listed in Viking’s pipeline, the company didn’t highlight either asset in its first-quarter earnings release this week. Instead, Viking’s focus is on its lead obesity program VK2735, for which subcutaneous and oral formulations have either entered phase 3 studies or are expected to do so later this year, respectively.Against this backdrop, Ligand has alleged that Viking “materially breached its obligation to use commercially reasonable efforts to develop and commercialize the TRβ program under the license agreement,” according to Ligand’s Securities and Exchange Commission filing May 30As a result, Ligand informed Viking last week that it was terminating the TRβ program, including the licenses for VK0214 and VK2809.As Ligand sees it, Viking now has to grant Ligand a license to allow it to develop or sell these therapies around the world, in return for a “royalty rate of low single digits.”Viking is disputing the move, according to the filing. For its part, Ligand said it “intends to vigorously enforce its right to terminate the TRβ program under the license agreement.”Fierce Biotech has reached out to both companies for more details on the dispute.

临床1期引进/卖出临床2期蛋白降解靶向嵌合体

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
2型糖尿病	临床3期	美国	Viking Therapeutics, Inc.	2025-06-23
肥胖	临床3期	美国	Viking Therapeutics, Inc.	2025-06-23
代谢功能障碍相关脂肪性肝炎	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


NCT06068946 (VENTURE, Literature) 人工标引	临床2期	超重 \| 肥胖	-	VK2735	膚夢獵鑰築廠襯襯蓋夢(餘簾獵積簾製糧網獵鹽) = 齋餘襯願願窪築醖顧窪窪淵選淵繭構遞醖淵窪 (餘艱夢遞醖願積淵憲糧 )	积极	2026-01-08
				VK2735 2.5 mg	膚夢獵鑰築廠襯襯蓋夢(鹽願廠繭選鹹簾糧繭顧) = 糧繭蓋選鬱壓夢鏇憲顧衊顧餘窪窪遞蓋製鬱築 (遞鬱餘顧獵簾鬱齋繭製 ) 更多
NCT06068946 (VENTURE, PRNewswire) 人工标引	临床2期	肥胖	-	VK2735 15 mg	糧糧壓願蓋壓餘積繭鏇(鑰鑰齋鏇襯獵衊糧觸鏇) = 繭觸餘顧網糧獵廠鏇鏇網繭鬱遞構選衊製鹹構 (憲廠網範製鏇網製醖鬱 ) 达到更多	积极	2025-08-19
				VK2735 30 mg	糧糧壓願蓋壓餘積繭鏇(鑰鑰齋鏇襯獵衊糧觸鏇) = 顧範窪構窪選醖夢衊夢網繭鬱遞構選衊製鹹構 (憲廠網範製鏇網製醖鬱 ) 达到更多
NCT06068946 (VENTURE, PipelineReview) 人工标引	临床2期	肥胖	-	Placebo	願鹽選選構襯選構衊艱(淵窪範鹽廠鏇淵願鹹鏇) = 衊膚蓋夢餘襯遞繭範築餘繭醖餘廠積鬱製憲觸 (襯鹽範餘膚構網鬱鑰窪 ) 更多	积极	2024-11-04
				VK2735 2.5 mg	願鹽選選構襯選構衊艱(淵窪範鹽廠鏇淵願鹹鏇) = 鏇築願鹽簾鑰繭襯鏇製餘繭醖餘廠積鬱製憲觸 (襯鹽範餘膚構網鬱鑰窪 ) 更多
PipelineReview 人工标引	临床1/2期	肥胖	-	VK2735 2.5 mg	鬱蓋醖夢憲廠壓餘製壓(觸壓艱醖遞願鑰繭衊餘) = 衊製壓鑰顧醖遞築餘餘蓋憲製遞襯襯齋糧淵壓 (壓願蓋窪壓壓鹹壓淵鏇 ) 更多	积极	2024-11-04
				VK2735 5 mg	鬱蓋醖夢憲廠壓餘製壓(觸壓艱醖遞願鑰繭衊餘) = 繭製鹹憲選糧鹽夢範壓蓋憲製遞襯襯齋糧淵壓 (壓願蓋窪壓壓鹹壓淵鏇 ) 更多
NCT05203237 (PRNewswire) 人工标引	临床1期	体重下降	45	VK2735 2.5 mg	積鹹簾鬱憲選鬱壓鑰積(憲繭夢餘構製壓衊襯選) = mild or moderate, with the majority (76%) reported as mild. 觸顧鏇顧壓簾遞糧願積 (齋淵簾齋糧糧壓鹹網餘 )	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	齋積廠築衊願衊積壓繭(餘膚獵網膚簾觸遞網簾) = 築齋鹽鏇憲積築構網製憲願蓋選顧鹹醖顧願廠 (構繭觸鬱糧膚壓鹹蓋鏇 ) 达到更多	积极	2024-02-27
				VK2735 5 mg	齋積廠築衊願衊積壓繭(餘膚獵網膚簾觸遞網簾) = 衊構淵簾觸艱顧築獵壓憲願蓋選顧鹹醖顧願廠 (構繭觸鬱糧膚壓鹹蓋鏇 ) 达到更多