GL0034 administered once-weekly confirmed clinically meaningful weight loss and improved gluco-metabolic parameters over a 4-week treatment period in individuals with obesity, even in the lowest dosing regimen.

每周服用一次的GL0034证实了肥胖患者在4周的治疗期间具有临床意义的体重减轻和改善的糖代谢参数，即使在最低的给药方案中也是如此。

GL0034 demonstrated gluco-metabolic activity and reductions in lipid levels, including triglycerides, total cholesterol, and non-HDL cholesterol, suggesting novel and beneficial effects on lipid metabolism.

GL0034表现出葡萄糖代谢活性和脂质水平的降低，包括甘油三酯，总胆固醇和非HDL胆固醇，表明对脂质代谢有新的有益作用。

GL0034 exhibited a favorable tolerability profile, with gastrointestinal (GI) adverse events consistent with those typically observed in the incretin class.

GL0034表现出良好的耐受性，胃肠道（GI）不良事件与肠促胰岛素类中通常观察到的不良事件一致。

These findings highlight GL0034's potential as a therapeutic option for individuals with obesity, providing not only weight loss but also improvements in key cardiometabolic biomarkers.

这些发现突出了GL0034作为肥胖患者治疗选择的潜力，不仅可以减轻体重，还可以改善关键的心脏代谢生物标志物。

MUMBAI, India and NEW YORK, June 22, 2024 /PRNewswire/ --Sun Pharmaceutical Industries Limited (Reuters: SUN.BO) (Bloomberg: SUNP IN) (NSE: SUNPHARMA) (BSE: 524715) (together with its subsidiaries and/or associates referred as 'Sun Pharma') announced results from a Phase 1, multiple ascending-dose study evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of GL0034 (Utreglutide) in obese adults.

印度孟买和纽约，2024年6月22日/PRNewswire/--Sun Pharmaceutical Industries Limited（路透社：Sun.BO）（彭博社：SUNP IN）（NSE：SUNPHARMA）（BSE:524715）（及其子公司和/或关联公司称为“Sun Pharma”）宣布了一项第一阶段多剂量递增研究的结果，该研究评估了GL0034（乌曲鲁肽）在肥胖成年人中的安全性，耐受性，药代动力学和药效学。

The data was exhibited in an oral presentation at the 84th Scientific Sessions of the American Diabetes Association (ADA), on June 21, 2024, in Orlando, FL..

该数据于2024年6月21日在佛罗里达州奥兰多举行的美国糖尿病协会（ADA）第84届科学会议上进行了口头展示。。

Obesity is a rapidly growing global health concern, contributing to numerous metabolic disorders, including type 2 diabetes mellitus (T2DM), cardiovascular diseases, and metabolic dysfunction-associated steatohepatitis (MASH). Effective treatments are crucial for managing obesity and its associated comorbidities.

肥胖是一个迅速增长的全球健康问题，导致许多代谢紊乱，包括2型糖尿病（T2DM），心血管疾病和代谢功能障碍相关的脂肪性肝炎（MASH）。有效的治疗对于控制肥胖及其相关合并症至关重要。

GLP-1 (glucagon-like peptide-1) receptor agonists have emerged as a promising therapeutic class for obesity..

GLP-1（胰高血糖素样肽-1）受体激动剂已成为一种有前途的肥胖治疗药物。。

GL0034 (Utreglutide) is a novel differentiated incretin analogue with potent, long-acting agonist activity at the GLP-1 receptor. This innovative compound is under evaluation for its potential to provide significant clinical benefits beyond weight loss and gluco-metabolic benefits in individuals with obesity..

GL0034（Utreglutide）是一种新型分化的肠降血糖素类似物，在GLP-1受体上具有有效的长效激动剂活性。这种创新化合物正在评估其在肥胖症患者体重减轻和糖代谢益处之外提供显着临床益处的潜力。。

'The recent GL0034 study has shown encouraging results with significant weight loss and notable improvements in lipid profiles among obese participants,' said Richard E. Pratley, MD, Medical Director, AdventHealth Diabetes Institute and Senior Investigator, Diabetes Program Lead, Translational Research Institute.

AdventHealth糖尿病研究所医学主任兼转化研究所糖尿病项目负责人高级研究员理查德·普拉特利（Richard E.Pratley）医学博士说：“最近的GL0034研究显示，肥胖参与者的体重显着减轻，血脂谱显着改善，结果令人鼓舞。”。

'This investigational therapy stands out as a potentially differentiated asset in the weight management field. The positive outcomes emphasize the potential of this treatment and set the stage for further research and development.'.

“这种研究疗法在体重管理领域是一种潜在的差异化资产。积极的结果强调了这种治疗的潜力，并为进一步的研究和开发奠定了基础。”。

'The promising data from our GL0034 study highlights our commitment to addressing the growing global health challenge of obesity. These findings not only demonstrate the activity of GL0034 in promoting weight loss but also underscore its potential in improving crucial cardiometabolic parameters and risk factors,' said Dilip Shanghvi, Managing Director, Sun Pharma.

“我们GL0034研究的有希望的数据突显了我们致力于解决肥胖日益严重的全球健康挑战。Sun Pharma董事总经理Dilip Shanghvi说，这些发现不仅证明了GL0034在促进减肥方面的活性，而且强调了其在改善关键心脏代谢参数和危险因素方面的潜力。

'We are dedicated to advancing this innovative therapy to bring meaningful benefits to patients worldwide.'.

“我们致力于推进这种创新疗法，为全球患者带来有意义的益处。”。

GL0034 Oral Presentation at the ADA 2024 Scientific Sessions

GL0034在ADA 2024科学会议上的口头介绍

Safety, Tolerability, and Metabolic Effects of Once-Weekly GL0034 (Utreglutide) in Individuals with Obesity—A Multiple Ascending Dose Study. [Oral Presentation #121-OR, Friday, June 21, 2024, 05:00pm-5:15pm ET, W415C (Valencia Ballroom), Presented by Dr. Rajamannar Thennati]

肥胖患者每周一次GL0034（乌曲鲁肽）的安全性，耐受性和代谢作用-一项多次递增剂量研究。[口头报告#121-OR，2024年6月21日星期五，美国东部时间05:00pm-5:15pm，W415C（巴伦西亚舞厅），由Rajamannar Thennati博士介绍]

Healthy, obese male participants (n=24; Age 18-40; BMI ≥ 28 kg/m²) were enrolled into a fixed-dose Cohort 1 (4 x 680 µg) or an increasing-dose Cohort 2 (680/900/1520/2000 µg) and assigned to treatment groups in a 3:1 ratio, receiving 4 weekly doses of either GL0034 or a placebo. An oral glucose tolerance test (OGTT) was performed on Day -1 (baseline) and Day 23 (after the 4th dose).

健康肥胖的男性参与者（n=24；年龄18-40岁；BMI≥28 kg/m²）被纳入固定剂量队列1（4 x 680µg）或增加剂量队列2（680/900/1520/2000µg），并以3:1的比例分配给治疗组，每周接受4剂GL0034或安慰剂。在第1天（基线）和第23天（第4次给药后）进行口服葡萄糖耐量试验（OGTT）。

The results were as follows:.

结果如下：。

Significant body weight reduction was observed from baseline at Day 29 and persisted through Day 43 in treatment cohorts compared to placebo.- Absolute weight loss change of –4.6 ± 1.5 (P<0.001) in Cohort 2.

与安慰剂相比，治疗组在第29天从基线观察到体重显着减轻，并持续到第43天队列2中的绝对体重减轻变化为–4.6±1.5（P＜0.001）。

Both cohorts showed significant reductions in glucose AUC0-120 min during OGTT on Day 23 and dose-dependent insulin AUC0-120 min reductions, suggesting improved insulin sensitivity.

两个队列均显示在第23天的OGTT期间葡萄糖AUC0-120分钟显着降低，并且剂量依赖性胰岛素AUC0-120分钟降低，表明胰岛素敏感性改善。

HbA1c, leptin levels, and lipid levels (triglycerides, total cholesterol, non-HDL cholesterol) were reduced in the treatment cohorts.

在治疗队列中，HbA1c，瘦素水平和脂质水平（甘油三酯，总胆固醇，非HDL胆固醇）降低。

GL0034 was well-tolerated with no treatment-related discontinuations. The most common adverse events were gastrointestinal, consistent with the incretin class profile.

。最常见的不良事件是胃肠道，与肠降血糖素类别一致。

The study was conducted in Belgium.

这项研究是在比利时进行的。

The accumulating evidence suggests that GL0034 has a potentially differentiated profile in the evolving landscape of obesity treatment. The Phase 1 study results have demonstrated clinically meaningful weight loss, significant metabolic improvements, and a favorable tolerability profile. Notably, GL0034 has shown a novel ability to lower lipid profiles, especially triglycerides, suggesting an additional therapeutic benefit that sets it apart from other treatments.

越来越多的证据表明，GL0034在肥胖治疗的不断发展中具有潜在的差异。第一阶段的研究结果表明，临床上有意义的体重减轻，显着的代谢改善以及良好的耐受性。值得注意的是，GL0034显示出降低血脂，特别是甘油三酯的新能力，这表明它具有与其他治疗方法不同的额外治疗益处。

As a selective GLP-1 receptor agonist, GL0034 shows potential for enhanced therapeutic benefits..

作为选择性GLP-1受体激动剂，GL0034显示出增强治疗益处的潜力。。

'The significant weight loss and metabolic improvements observed with GL0034 strongly support the further clinical evaluation of this novel GLP-1 receptor agonist for treating obesity, type 2 diabetes, metabolic dysfunction-associated steatohepatitis, and other weight-related comorbidities. To confirm these benefits, we will conduct larger, randomized controlled studies to fully elucidate the therapeutic potential of GL0034 for patients,' said Rajamannar Thennati, MD, Lead Investigator and Executive Vice President, Research & Development, Sun Pharma.

“用GL0034观察到的显着体重减轻和代谢改善强烈支持这种新型GLP-1受体激动剂治疗肥胖，2型糖尿病，代谢功能障碍相关脂肪性肝炎和其他体重相关合并症的进一步临床评估。“为了证实这些益处，我们将进行更大规模的随机对照研究，以充分阐明GL0034对患者的治疗潜力，”Sun Pharma首席研究员兼研发执行副总裁Rajamannar Thennati医学博士说。

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About Sun Pharmaceutical Industries Limited (CIN - L24230GJ1993PLC019050)

Sun Pharma is a leading global specialty generics company with presence in Innovative products, Generics and Consumer Healthcare products. It is the largest pharmaceutical company in India and is a leading generic company in the US as well as Global Emerging Markets. Sun's high growth Global Specialty portfolio spans innovative products in dermatology, ophthalmology, and onco-dermatology and accounts for over 18% of company sales.

Sun Pharma是一家领先的全球专业仿制药公司，在创新产品、仿制药和消费保健产品领域占有一席之地。它是印度最大的制药公司，也是美国和全球新兴市场领先的仿制药公司。Sun高速增长的全球专业产品组合涵盖皮肤科、眼科和肿瘤皮肤科的创新产品，占公司销售额的18%以上。

The company's vertically integrated operations deliver high-quality medicines, trusted by physicians and consumers in over 100 countries. Its manufacturing facilities are spread across six continents. Sun Pharma is proud of its multi-cultural workforce drawn from over 50 nations. For further information, please visit www.sunpharma.com and follow us on 'X' @SunPharma_Live..

该公司垂直整合的业务提供高质量的药物，受到100多个国家的医生和消费者的信任。。Sun Pharma为其来自50多个国家的多元文化员工队伍感到自豪。欲了解更多信息，请访问www.sunpharma.com，并通过“X”@sunpharma\u Live关注我们。。

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