drugset / Press release

Sun Pharma Presents Two Posters on Utreglutide at ObesityWeek® 2025

2025-11-12 · Sun Pharmaceutical Industries, Inc. · original sunpharma.com ↗

Sun Pharmaceutical Industries Limited SUN HOUSE, CTS No. 201 B/1, Western Express Highway, Goregaon (E), Mumbai 400063, India Tel.: (91-22) 4324 4324 Fax.: (91-22) 4324 4343 CIN: L24230GJ1993PLC019050 www.sunpharma.com Registered Office: SPARC, Tandalja, Vadodara – 390 020. India Reaching People. Touching Lives. FOR IMMEDIATE RELEASE Sun Pharma Presents Two Posters on Utreglutide at ObesityWeek® 2025 Thirteen weeks of utreglutide dosing in individuals with obesity and MASLD showed significant body weight reduction of 6.8% and change in waist circumference of 6.8% at week 14 In individuals with overweight and obesity, once weekly utreglutide dosing for ten weeks demonstrated body weight loss of 6.8% and TC and LDL reductions of ∼10% with pronounced effect on LDL in individuals with higher baseline value Utreglutide was well tolerated, with the most frequent adverse events being gastrointestinal, consistent with the class of drugs MUMBAI, India and PRINCETON, N.J., November 12, 2025 – Sun Pharmaceutical Industries Ltd. (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715, “Sun Pharma” including its subsidiaries and/or associate companies) announced two poster presentations at the ObesityWeek® 2025 Scientific Sessions held from November 4-7, 2025, in Atlanta, USA. In one of the posters, data from a subgroup of Phase 1b/2a Study of utreglutide (GL0034) in overweight and obese individuals and Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD) in a phase 1b/2a study was presented. The subgroup comprised individuals with Class III Obesity and MASLD . Thirteen weeks of utreglutide dosing in individuals with obesity and MASLD showed body weight and waist circumference reduction, improved cardio -metabolic markers, significant liver fat loss in 31% of subjects, and reduced urate levels, indicating potential benefits for MASLD resolution and co -morbid conditions like atherosclerosis and renal disease. The drug was well tolerated, with the most common adverse events occurring in ≥5 participants receiving GL0034 were nausea, diarrhoea and vomiting. The study was conducted in Australia. In the other poster, data from a 10-week safety and e fficacy study administering utreglutide (GL0034) in individuals with obesity was presented. Once-weekly utreglutide dosing over ten weeks in individuals with overweight and obesity led to 6.8% body weight loss, about 10% TC and LDL reduction, 16.3% ApoB drop, and significant improvements in inflammatory markers, liver enzymes, and fatty liver index. The study suggested that the drug may show promise for managing cardiovascular risks, with or without type 2 diabetes. The study was conducted in Belgium. Sun Pharmaceutical Industries Limited SUN HOUSE, CTS No. 201 B/1, Western Express Highway, Goregaon (E), Mumbai 400063, India Tel.: (91-22) 4324 4324 Fax.: (91-22) 4324 4343 CIN: L24230GJ1993PLC019050 www.sunpharma.com Registered Office: SPARC, Tandalja, Vadodara – 390 020. India Reaching People. Touching Lives. “Obesity and related metabolic conditions continue to challenge the health and well- being of individuals worldwide,” said Dilip Shanghvi, Chairman, Sun Pharma. “ At Sun Pharma, we are committed to exploring innovative solutions that can help improve patient outcomes. The early findings with utreglutide are promising and reinforce our focus on developing therapies that address unmet needs in a meaningful and accessible way.” “We observed encouraging reductions in liver fat and improvements across key metabolic parameters with utreglutide in individuals with obesity and MASLD. In a separate study, the treatment also showed favorable effects on lipid profiles and inflammatory markers in individuals with obesity without diabetes. Utreglutide was well tolerated, and these early findings support continued investigation across broader patient populations.” , said said Rohit Loomba, Professor of Medicine (with tenure), Chief, Division of Gastroenterology and Hepatology, University of California at San Diego. GL0034 was discovered and is being developed by Sun Pharma. Further clinical studies are planned to assess clinical safety and efficacy. Utreglutide (GL0034) in Subgroup of Individuals with Class III Obesity and MASLD: Phase 1b/2a Study A Phase 1b/2a Study of The Novel GLP -1 Receptor Agonist GL0034 (Utreglutide) in the Treatment of MASLD . [Poster, Tuesday , November 4 , 2025 , 7:30pm – 8:30pm ET, Exhibit Hall A1 , Pr esented by Dr. Rajamannar Thennati] • Participants (n=48; BMI ≥30 kg/m2; Controlled attenuated parameter (CAP) ≥306 dB/m via FibroScan®; Liver fat content ≥10%, as assessed by MRI-PDFF) were randomized 3:1 to treatment with GL0034 (uptitration from 0.4 mg-1.6mg for 10 weeks and fixed dose of 2.4 mg for 3 weeks; total dose 17.6 mg ) or placebo for 13 weeks. Data from strata of participants with Class III obesity (23-69 years of age) is presented (13 in GL0034 treatment group and 5 placebo). At Week 14, t he GL0034-treated participants achieved mean percent change of -6.8% in body weight, which sustained beyond initial treatment exposure through Week 17. It was accompanied by mean change of 3.7 inches in waist circumference at Week 14 in GL0034-treated participants against -0.5 inches for placebo- treated participants. • Triglyceride and total cholesterol levels were significantly decreased (P<0.05) along with ApoB (P<0.01) from baseline in participants treated with GL0034 . The relative liver fat content in GL0034- treated participants reduced significantly from baseline (MRI-PDFF, P<0.001) as compared to placebo 1.3% (MRI-PDFF) and 31% achieved more than 30% liver fat reduction. The mean percent change from baseline in urate levels were - 11.5% for GL0034-treated participants as compared to 0.6% in placebo-treated participants, and the number of subjects with urate level of less than 0.35 mmol/L doubled at week 14 as compared to baseline in GL0034-treated group. Sun Pharmaceutical Industries Limited SUN HOUSE, CTS No. 201 B/1, Western Express Highway, Goregaon (E), Mumbai 400063, India Tel.: (91-22) 4324 4324 Fax.: (91-22) 4324 4343 CIN: L24230GJ1993PLC019050 www.sunpharma.com Registered Office: SPARC, Tandalja, Vadodara – 390 020. India Reaching People. Touching Lives. • The most common AEs occurring in participants receiving GL0034 were gastrointestinal with mild-moderate intensity. They included nausea, while diarrhoea and vomiting were reported by only 15% of participants. Utreglutide (GL0034) in Individuals with Obesity: 10-week Safety and Efficacy Study Outcomes A Proof of Concept Study of The Novel GLP -1 Receptor Agonist GL0034 (Utreglutide) in Overweight Obese Individuals Without Diabetes . [Poster, Tuesday , November 4 , 202 5, 7:30pm – 8:30pm ET, Exhibit Hall A1 , Presented by Dr. Rajamannar Thennati] • Participants (n=20; B M I ≥28 and ≤ 45 kg/m2) were randomized 4:1 to once-weekly treatment with GL0034 (uptitration from 0.4 mg–2 mg) or placebo for 10 weeks. At week 11, GL0034 treated participants achieved placebo corrected mean percent change in body weight of - 6.5 ( P<0.001) at total dose of 14.2 mg, which sustained beyond initial treatment exposure through week 14 at -6.2% (P<0.001). • Total cholesterol levels were significantly decreased from baseline in GL0034-treated participants with mean percent changes of -11.9 ( P<0.01) along with LDL (- 9.6%; P<0.05) at Week 10 , compared to an increase of 8.4 % and 23.2% in plac ebo-treated individuals. In 57% of GL0034-treated participants (baseline LDL more than 120 mg/dl) the mean BL of 153 mg/dL reduced by 31 mg/dL. A therogenic ApoB levels reduced with significance (P<0.001); hsCRP levels reduced by 31% and 29% participants achieved less than 1.5 mg/L hsCRP levels. The mean change in ALT levels was - 13 U/L in GL0034 - treated participants. • Most common AEs occurring in GL0034 -treated participants were gastrointestinal, with mild to moderate intensity and observed in <20% participants. About GL0034 GL0034 (utreglutide) is an investigational novel glucagon -like peptide 1 receptor agonist (GLP - 1RA) in development as a once -weekly, long -acting, antidiabetic medication in patients with obesity and type 2 diabetes. Further clinical studies are planned to assess clinical safety and effectiveness. About Sun Pharmaceutical Industries Ltd. (CIN - L24230GJ1993PLC019050) Sun Pharma is the world’s leading specialty generics company with a presence in specialty, generics and consumer healthcare products. It is the largest pharmaceutical company in India and is a leading generic company in the U.S. as well as global emerging markets. Sun Pharma’s high-growth global specialty portfolio spans innovative products in dermatology, ophthalmology, and onco-dermatology and accounts for about 20% of company sales. 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 Sun Pharmaceutical Industries Limited SUN HOUSE, CTS No. 201 B/1, Western Express Highway, Goregaon (E), Mumbai 400063, India Tel.: (91-22) 4324 4324 Fax.: (91-22) 4324 4343 CIN: L24230GJ1993PLC019050 www.sunpharma.com Registered Office: SPARC, Tandalja, Vadodara – 390 020. India Reaching People. Touching Lives. of its multicultural workforce drawn from over 50 nations. For further information, please visit www.sunpharma.com and follow us on LinkedIn & X (Formerly Twitter). Disclaimer Statements in this “Document” describing the Company’s objectives, projections, estimates, expe ctations, plans or predictions or industry conditions or events may be “forward looking statements” within the meaning of applicable securities laws and regulations. Actual results, performance or achievements could differ materially from those expressed o r implied. The Company undertakes no obligation to update or revise forward looking statements to reflect developments or circumstances that arise or to reflect the occurrence of unanticipated developments/circumstances after the date hereof. Contacts Investors Media Dr. Abhishek Sharma Gaurav Chugh Tel + 91 22 4324 4324, Ext 2929 Tel + 91 22 4324 4324, Ext 5373 Tel Direct + 91 22 43242929 Tel Direct + 91 22 43245373 Mobile + 91 98196 86016 Mobile + 91 98104 71414 E mail [email protected] E mail [email protected]

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