Study Achieves Primary and all Secondary Endpoints, Demonstrating Statistically Significant Reductions in Body Weight at all Doses as Compared to Placebo

这项研究达到了主要和所有次要终点，表明与安慰剂相比，所有剂量的体重均有统计学意义上的显着降低

Up to 13.1% Placebo-Adjusted Mean Weight Loss (14.7% From Baseline) Observed After 13 Weeks of Treatment; No Plateau Observed

治疗13周后观察到高达13.1%的安慰剂调整后的平均体重减轻（从基线开始为14.7%）；未观察到平台

VK2735 Shown to be Safe and Well-Tolerated in 13-Week Study; 95% of GI-specific Treatment Emergent Adverse Events Considered Mild or Moderate

在为期13周的研究中，VK2735被证明是安全且耐受性良好的；95%的胃肠道特异性治疗紧急不良事件被认为是轻度或中度

Conference Call Scheduled for 8:00 a.m. ET Today

电话会议定于美国东部时间今天上午8:00

SAN DIEGO, Feb. 27, 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 positive top-line results from the company's Phase 2 clinical trial of VK2735, a dual agonist of the glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptors in development for the potential treatment of various metabolic disorders such as obesity.  The Phase 2 VENTURE trial successfully achieved its primary endpoint and all secondary endpoints, with patients receiving VK2735 demonstrating statistically significant reductions in body weight compared with placebo.  Additionally, the study showed VK2735 treatment to be safe and well tolerated with the majority of treatment emergent adverse events (TEAEs) being categorized as mild or moderate.  Based on these findings, Viking intends to meet with the FDA and discuss next steps in the development of VK2735..

圣地亚哥，2024年2月27日/PRNewswire/--Viking Therapeutics，Inc.（“Viking”）（纳斯达克：VKTX），一家专注于开发代谢和内分泌疾病新疗法的临床阶段生物制药公司，今天宣布了该公司对胰高血糖素样肽1（GLP-1）双重激动剂VK2735的2期临床试验的积极结果和葡萄糖依赖性促胰岛素多肽（GIP）受体正在开发中，用于潜在治疗各种代谢紊乱，如肥胖。第二阶段VENTURE试验成功实现了其主要终点和所有次要终点，与安慰剂相比，接受VK2735治疗的患者体重显着降低。此外，该研究表明，VK2735治疗安全且耐受性良好，大多数治疗紧急不良事件（TEAE）被归类为轻度或中度。基于这些发现，维京计划与FDA会面，讨论VK2735开发的下一步。。

Top-line study results include:

一线研究结果包括：

Body Weight Reductions

体重减轻

Patients receiving weekly doses of VK2735 demonstrated statistically significant reductions in mean body weight after 13 weeks, ranging up to 14.7% from baseline. Patients receiving VK2735 also demonstrated statistically significant reductions in mean body weight relative to placebo, ranging up to 13.1%.

接受每周剂量VK2735的患者在13周后表现出平均体重的统计学显着降低，与基线相比高达14.7%。与安慰剂相比，接受VK2735治疗的患者平均体重也显示出统计学上的显着降低，范围高达13.1%。

Statistically significant differences compared to both baseline and placebo were observed for all doses starting at Week one and continuing throughout the 13-week treatment period. Reductions in body weight were progressive through the course of the study, with no plateau observed for weight loss at 13 weeks.

与基线和安慰剂相比，从第一周开始并在整个13周治疗期间持续的所有剂量均观察到统计学上显着的差异。在整个研究过程中，体重的减轻是渐进的，在13周时没有观察到体重减轻的平台。

All doses of VK2735 also demonstrated statistically significant differences relative to placebo on the key secondary endpoint assessing the proportion of patients demonstrating at least 10% weight loss.  Up to 88% of patients in VK2735 treatment groups achieved ≥10% weight loss, compared with 4% for placebo..

所有剂量的VK2735在评估体重减轻至少10%的患者比例的关键次要终点上也显示出相对于安慰剂的统计学显着差异。VK2735治疗组中高达88%的患者体重减轻≥10%，而安慰剂组为4%。。

Observed Change in Body Weight Following 13 Weeks of Once-Weekly Dosing with VK2735

观察到每周服用一次VK2735 13周后体重的变化

Dose Level1,2

剂量水平1,2

Placebo (n=34)

安慰剂（n=34）

VK2735 2.5 mg (n=35)

VK2735 2.5 mg (n=35)

VK2735 5 mg (n=35)

VK2735 5 mg (n=35)

VK2735 10 mg (n=35)

VK2735 10 mg (n=35)

VK2735 15 mg (n=35)

VK2735 15 mg (n=35)

Mean baseline body weight (kg)3

平均基线体重（kg）3

105.3 kg

105.3千克

103.1 kg

103.1千克

98.3 kg

98.3千克

103.4 kg

103.4千克

101.1 kg

101.1千克

Mean change from baseline bodyweight4,5

基线体重的平均变化4,5

-1.8 kg

-1.8千克

-9.2 kg

-9.2千克

-10.7 kg

-10.7千克

-13.3 kg

-13.3千克

-14.6 kg

-14.6千克

Mean percent change from baseline4,5

与基线相比的平均百分比变化4,5

-1.7 %

-1.7 %

-9.1 %

-9.1 %

-10.9 %

-10.9 %

-12.9 %

-12.9 %

-14.7 %

-14.7 %

Placebo-adjustedmean percent changefrom baseline4,5

安慰剂调整后的基线平均百分比变化4,5

-

-（笑声）

-7.4 %

-7.4 %

-9.2 %

-9.2 %

-11.3 %

-11.3 %

-13.1 %

-13.1 %

p-value vs. placebo5

p值与安慰剂5

-

-（笑声）

< 0.0001

< 0.0001

< 0.0001

< 0.0001

< 0.0001

< 0.0001

< 0.0001

< 0.0001

Percent reporting ≥ 10% weight loss

报告体重减轻≥10%的百分比

4 %

4 %

39 %

39 %

62 %

62 %

70 %

70 %

88 %

88 %

p-value vs. placebo6

p值与安慰剂6

-

-（笑声）

0.0036

0.0036

0.0002

0.0002

< 0.0001

< 0.0001

< 0.0001

< 0.0001

Notes: 1) Efficacy population, includes all randomized patients who received at least one dose of study drug and had a valid baseline and post-baseline body weight assessment. 2) Patients treated with VK2735 were titrated to final doses as indicated: 2.5 mg cohort = 2.5 x 13 weeks; 5 mg cohort = 2.5 mg x 3 wks, 5 mg x 10 wks; 10 mg cohort = 2.5 mg x 3 wks, 5 mg x 3 wks, 7.5 mg x 3 wks, 10 mg x 4 wks; 15 mg cohort = 5 mg x 3 wks, 7.5 mg x 3 wks, 10 mg x 3 wks, 15 mg x 4 wks.

注：1）疗效人群，包括所有接受至少一剂研究药物且具有有效基线和基线后体重评估的随机患者。2） 如所示，用VK2735治疗的患者滴定至最终剂量：2.5 mg队列=2.5 x 13周；5毫克队列=2.5毫克x 3周，5毫克x 10周；10 mg队列=2.5 mg x 3 wks，5 mg x 3 wks，7.5 mg x 3 wks，10 mg x 4 wks；15 mg队列=5 mg x 3 wks，7.5 mg x 3 wks，10 mg x 3 wks，15 mg x 4 wks。

3) All enrolled patients were required to have baseline BMI ≥30 kg/m2 or BMI≥27 kg/m2 with at least one weight-related comorbid condition. 4) Least squares mean. 5) Two-sided t test using mixed model for repeated measures. 6) Logistic regression model with treatment as factor and baseline weight as covariate.

3） 所有入选患者的基线BMI≥30 kg/m2或BMI≥27 kg/m2，至少有一种与体重相关的合并症。4） 最小二乘平均值。5） 使用混合模型进行重复测量的双侧t检验。6） 以治疗为因素，基线体重为协变量的Logistic回归模型。

.

.

Safety and Tolerability

安全性和耐受性

VK2735 demonstrated encouraging safety and tolerability following 13 weeks of once-weekly dosing. Discontinuation rates in the VENTURE study were low and well-balanced among patients treated with VK2735 compared with placebo. A total of 23 patients (13%) discontinued treatment in the study, 5 (14%) in the placebo cohort and 18 (13%) among VK2735-treated cohorts..

在每周一次给药13周后，VK2735表现出令人鼓舞的安全性和耐受性。与安慰剂相比，接受VK2735治疗的患者在VENTURE研究中的停药率较低且平衡良好。该研究共有23名患者（13%）停止治疗，安慰剂组5名（14%）和VK2735治疗组18名（13%）。。

Among patients receiving VK2735, the majority (92%) reported drug related TEAEs as mild or moderate in severity. The majority of TEAEs that were gastrointestinal (GI) in nature (95%) were also reported as mild or moderate. Nausea was reported among patients receiving both VK2735 (43%) and placebo (20%).

在接受VK2735治疗的患者中，大多数（92%）报告与药物相关的TEAE严重程度为轻度或中度。大多数胃肠道（GI）性质的TEAE（95%）也被报道为轻度或中度。据报道，接受VK2735（43%）和安慰剂（20%）的患者出现恶心。

Among subjects receiving VK2735, the majority of reported nausea (68%) was characterized as mild (32% moderate, none severe). Vomiting was reported in 25/140 (18%) VK2735-treated patients compared with none reported among patients receiving placebo. GI-related adverse events were generally observed early in treatment, with decreasing frequency upon repeat dosing.

在接受VK2735治疗的受试者中，大多数报告的恶心（68%）表现为轻度（32%为中度，无严重）。据报道，接受VK2735治疗的患者中有25/140（18%）出现呕吐，而接受安慰剂的患者中没有出现呕吐。胃肠道相关不良事件通常在治疗早期观察到，重复给药后频率降低。

Across the combined VENTURE study arms, the weekly rate of nausea did not exceed 5% at any point after the first week of treatment. One patient receiving VK2735 experienced a serious adverse event (SAE) of dehydration that was characterized as related to study drug. .

在联合风险研究部门中，在治疗第一周后的任何时候，每周恶心率均不超过5%。一名接受VK2735治疗的患者经历了严重的脱水不良事件（SAE），其特征与研究药物有关。。

Discontinuation Rates and Common Gastrointestinal TEAEs Following 13 Weeks of Once-Weekly Dosing with VK2735

每周一次服用VK2735 13周后的停药率和常见胃肠道TEAE

Placebo (n=35)

安慰剂（n=35）

VK2735 2.5 mg (n=35)

VK2735 2.5 mg (n=35)

VK2735 5 mg (n=35)

VK2735 5 mg (n=35)

VK2735 10 mg (n=35)

VK2735 10 mg (n=35)

VK2735 15 mg (n=35)

VK2735 15 mg (n=35)

VK2735 Combined (n=140)

VK2735组合（n=140）

Discontinued treatment early

早期停止治疗

5 (14 %)

5 (14 %)

2 (6 %)

2 (6 %)

4 (11 %)

4 (11 %)

5 (14 %)

5 (14 %)

7 (20 %)

7 (20 %)

18 (13 %)

18 (13 %)

Discontinued study early

提前停止学习

2 (6 %)

2 (6 %)

0 (0 %)

0 (0 %)

1 (3 %)

1 (3 %)

2 (6 %)

2 (6 %)

2 (6 %)

2 (6 %)

5 (4 %)

5 (4 %)

Common AEs, # of Subjects reporting, (%)

常见不良事件，#受试者报告，（%）

Nausea

恶心

Mild     Moderate     Severe

轻度中度重度

7 (20%) 0 (0%) 0 (0%)

7 (20%) 0 (0%) 0 (0%)

6 (17%) 3 (9%) 0 (0%)

6 (17%) 3 (9%) 0 (0%)

11 (31%) 5 (14%) 0 (0%)

11 (31%) 5 (14%) 0 (0%)

9 (26%) 4 (11%) 0 (0%)

9 (26%) 4 (11%) 0 (0%)

15 (43%) 7 (20%) 0 (0%)

15 (43%) 7 (20%) 0 (0%)

41 (29%) 19 (14%) 0 (0%)

41 (29%) 19 (14%) 0 (0%)

Vomiting

呕吐

0 (0 %)

0 (0 %)

3 (9 %)

3 (9 %)

6 (17 %)

6 (17 %)

6 (17 %)

6 (17 %)

10 (29 %)

10 (29 %)

25 (18 %)

25 (18 %)

Diarrhea

腹泻

3 (9 %)

3 (9 %)

11 (31 %)

11 (31 %)

6 (17 %)

6 (17 %)

7 (20 %)

7 (20 %)

4 (11 %)

4 (11 %)

28 (20 %)

28 (20 %)

Constipation

便秘

4 (11 %)

4 (11 %)

7 (20 %)

7 (20 %)

10 (29 %)

10 (29 %)

9 (26 %)

9 (26 %)

10 (29 %)

10 (29 %)

36 (26 %)

36 (26 %)

Decreasedappetite

食欲下降

0 (0 %)

0 (0 %)

2 (6 %)

2 (6 %)

5 (14 %)

5 (14 %)

9 (26 %)

9 (26 %)

6 (17 %)

6 (17 %)

22 (16 %)

22 (16 %)

Notes: Safety population, includes all randomized subjects who received at least one dose of study drug.

注意：安全人群，包括接受至少一剂研究药物的所有随机受试者。

'We are excited to report the top-line results from this important Phase 2 study. VK2735 continues to demonstrate a promising efficacy and tolerability profile following 13 weeks of repeat dosing in obese subjects,' said Brian Lian, Ph.D., chief executive officer of Viking. 'Notably, robust weight loss compared with placebo was observed early across all doses evaluated in the VENTURE study, and continued throughout the treatment period in all treatment groups.

“我们很高兴报告这项重要的第二阶段研究的最重要结果。Viking首席执行官BrianLian博士说，VK2735在肥胖受试者中重复给药13周后，继续显示出有希望的疗效和耐受性值得注意的是，在风险研究中评估的所有剂量中，早期观察到与安慰剂相比体重减轻，并且在所有治疗组的整个治疗期间都持续存在。

No evidence of a plateau was observed at Week 13 for any VK2735 dose, suggesting further weight loss might be achieved from extended dosing periods. We look forward to progressing this important therapy into further clinical development later this year. Separately, we remain on track to report data from a Phase 1 study of an oral formulation of VK2735 later this quarter.'.

对于任何VK2735剂量，在第13周没有观察到平台的证据，表明延长给药期可能会进一步减轻体重。我们期待着在今年晚些时候将这一重要疗法推进进一步的临床开发。另外，我们仍将在本季度晚些时候报告VK2735口服制剂的第一阶段研究数据。”。

The Phase 2 VENTURE trial was a randomized, double-blind, placebo-controlled study intended to evaluate the safety, tolerability, pharmacokinetics, and weight loss efficacy of VK2735, administered subcutaneously, once weekly.  The 13-week trial enrolled 176 adults who are obese (BMI ≥30 kg/m2), or adults who are overweight (BMI ≥27 kg/m2) with at least one weight-related comorbid condition.  The primary endpoint of the study was the assessment of the percent change in body weight from baseline to Week 13 among patients treated with VK2735 as compared with placebo, while secondary and exploratory endpoints evaluated a range of additional safety and efficacy measures..

第二阶段风险试验是一项随机，双盲，安慰剂对照研究，旨在评估每周一次皮下注射VK2735的安全性，耐受性，药代动力学和减肥功效。这项为期13周的试验招募了176名肥胖（BMI≥30 kg/m2）或超重（BMI≥27 kg/m2）且至少有一种体重相关合并症的成年人。该研究的主要终点是评估与安慰剂相比，接受VK2735治疗的患者从基线到第13周的体重变化百分比，而次要和探索性终点评估了一系列额外的安全性和有效性措施。。

Conference Call

电话会议

Management will host a conference call to discuss top-line results from the company's Phase 2 VENTURE trial today at 8:00 am Eastern.  To participate in the conference call, please dial (844) 850-0543 from the U.S. or (412) 317-5199 from outside the U.S.  In addition, following the completion of the call, a telephone replay will be accessible until March 5, 2024, by dialing (877) 344-7529 from the U.S.

管理层将于今天上午8:00东部时间召开电话会议，讨论公司第二阶段风险投资试验的最终结果。要参加电话会议，请从美国拨打（844）850-0543或从美国境外拨打（412）317-5199。此外，通话结束后，可以从美国拨打（877）344-7529，在2024年3月5日之前进行电话重播。

or (412) 317-0088 from outside the U.S. and entering conference ID # 6165205.  Those interested in listening to the conference call live via the internet may do so by visiting the Webcasts page of Viking's website at http://ir.vikingtherapeutics.com/webcasts.  An archive of the webcast will also be available on the Webcasts page of Viking's website for 30 days..

或（412）317-0088来自美国境外，并输入会议ID#6165205。有兴趣通过互联网收听电话会议直播的人可以访问Viking网站的网络广播页面http://ir.vikingtherapeutics.com/webcasts.维京人网站的网络广播页面上也将提供为期30天的网络广播档案。。

About GLP-1 and Dual GLP-1/GIP Agonists

关于GLP-1和双重GLP-1/GIP激动剂

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®.

胰高血糖素样肽1（GLP-1）受体的激活已被证明可降低2型糖尿病，肥胖症或两者患者的血糖，降低食欲，降低体重，并改善胰岛素敏感性。Semaglutide是一种GLP-1受体激动剂，已获得美国食品和药物管理局的批准，目前以各种剂量强度和形式销售，如Ozempic®，Rybelsus®和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®..

最近，研究工作已经探索了葡萄糖依赖性促胰岛素肽（GIP）受体的潜在共激活，作为增强GLP-1受体激活的治疗益处的手段。Tirzepatide是一种双重GLP-1/GIP受体激动剂，已获得美国食品和药物管理局的批准，目前以各种剂量和形式销售，如Mounjaro®和Zepbound®。。

About Viking Therapeutics, Inc.

关于Viking Therapeutics，Inc。

Viking Therapeutics 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 Therapeutics是一家临床阶段的生物制药公司，专注于开发用于治疗代谢和内分泌疾病的新型一流或一流疗法，目前有三种化合物正在临床试验中。Viking的研发活动利用其在新陈代谢方面的专业知识，开发旨在改善患者生活的创新疗法。

The company's clinical programs include VK2809, a novel, orally available, small molecule selective thyroid hormone receptor beta agonist for the treatment of lipid and metabolic disorders, which is currently being evaluated in a Phase 2b study for the treatment of biopsy-confirmed non-alcoholic steatohepatitis (NASH) and fibrosis.

该公司的临床项目包括VK2809，一种新型的口服小分子选择性甲状腺激素受体β激动剂，用于治疗脂质和代谢紊乱，目前正在进行2b期研究，用于治疗活检证实的非酒精性脂肪性肝炎（NASH）和纤维化。

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 is also developing 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.

在治疗非酒精性脂肪性肝病（NAFLD）和LDL-C升高的2a期临床试验中，接受VK2809的患者与接受安慰剂的患者相比，LDL-C和肝脏脂肪含量在统计学上显着降低。该公司还在开发VK2735，一种胰高血糖素样肽1（GLP-1）和葡萄糖依赖性促胰岛素多肽（GIP）受体的新型双重激动剂，用于潜在治疗各种代谢紊乱。

Data from a Phase 1 and a Phase 2a trial evaluating VK2735 (dosed subcutaneously) for metabolic disorders demonstrated an encouraging safety and tolerability profile as well as positive signs of clinical benefit. The company is also evaluating an oral formulation of VK2735 in a Phase 1 trial. In the rare disease space, the company 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). VK0214 is currently being evaluated in a Phase 1b clinical trial.

评估VK2735（皮下给药）治疗代谢紊乱的1期和2a期试验的数据显示，其安全性和耐受性令人鼓舞，并且具有临床益处的积极迹象。该公司还在一期试验中评估VK2735的口服制剂。在罕见疾病领域，该公司正在开发VK0214，这是一种新型的口服小分子选择性甲状腺激素受体β激动剂，可用于治疗X连锁肾上腺白质营养不良（X-ALD）。VK0214目前正在1b期临床试验中进行评估。

For more information about Viking Therapeutics, please visit www.vikingtherapeutics.com.

有关Viking Therapeutics的更多信息，请访问www.vikingtherapeutics.com。

Forward-Looking Statements

前瞻性声明

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.  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 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, 2023 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..

根据1995年《美国私人证券诉讼改革法案》的安全港条款，本新闻稿包含关于维京治疗公司的前瞻性声明，包括关于维京对其临床和临床前开发计划的期望的声明。前瞻性陈述受到风险和不确定性的影响，这些风险和不确定性可能导致实际结果产生重大不利差异，报告的结果不应被视为未来业绩的指标。这些风险和不确定性包括但不限于：与Viking产品候选开发活动和临床试验（包括VK2735，VK0214，VK2809和公司其他肠降血糖素受体激动剂）的成功，成本和时间相关的风险；先前的临床和临床前结果可能无法复制的风险；与监管要求有关的风险；以及维京向美国证券交易委员会提交的最新定期报告中描述的其他风险，包括维京截至2023年12月31日的10-K表年度报告，包括这些文件中规定的风险因素。这些前瞻性声明仅在本协议签署之日有效。维京不承担更新这些前瞻性声明的任何义务，除非法律要求。。

SOURCE Viking Therapeutics, Inc

来源Viking Therapeutics，Inc