utreglutide (GL0034) / Sun Pharma - LARVOL DELTA

Utreglutide (GL0034) in Subgroup of Individuals with Class III Obesity and MASLD: Phase 1b/2a Study (Sun Pharma Press Release) - "At Week 14, the 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 placebotreated participants....The relative liver fat content in GL0034-treated participants reduced significantly from baseline...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."

P1/2 data • Metabolic Dysfunction-Associated Steatohepatitis • Metabolic Dysfunction-Associated Steatotic Liver Disease • Obesity

Utreglutide (GL0034) in Individuals with Obesity: 10-week Safety and Efficacy Study Outcomes (Sun Pharma Press Release) - "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 placebo-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."

Clinical data • Obesity

Utreglutide (GL0034) in Subgroup of Individuals With Class III Obesity and MASLD: Phase 1b/2a Study (OBESITY WEEK 2025) - "Utreglutide was safe and well tolerated by subgroup of individuals with class III obesity and MASLD. Once-weekly dosing of UTG at a total dose of 17.6 mg in 13-weeks demonstrated clinically relevant changes in BW and biomarkers of cardio-metabolism along with non-invasive markers of MASLD suggesting potential therapeutic benefits in patients with obesity associated comorbidities."

Clinical • P1/2 data • Cardiovascular • Chronic Kidney Disease • Diabetes • Genetic Disorders • Hepatology • Liver Failure • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis • Metabolic Dysfunction-Associated Steatotic Liver Disease • Nephrology • Obesity • Obstructive Sleep Apnea • Renal Disease • Respiratory Diseases • Sleep Apnea • Sleep Disorder • Type 2 Diabetes Mellitus • APOB • LEP

Utreglutide (GL0034) in Individuals with Obesity: 10-Week Safety and Efficacy Study Outcomes (OBESITY WEEK 2025) - "Utreglutide was safe and well tolerated by individuals with overweight and obesity. Once-weekly dosing of UTG at a total dose of 14.2 mg in 10-weeks demonstrated clinically relevant changes in BW and biomarkers of cardio-metabolism along with FLI suggesting potential therapeutic benefits in patients with obesity spectrum disorders."

Clinical • Cardiovascular • Diabetes • Dyslipidemia • Genetic Disorders • Hepatology • Liver Failure • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus • APOB • CRP • LEP

Once Weekly Utreglutide (GL0034), a Glucagon-like Peptide-1 Receptor Agonist Reduces Liver Fat Content along with Blood Pressure in Post-menopausal Females with Obesity: A Phase 1a/2b Study (AHA 2025) - "The liver fat content was reduced by 28.6 % which was supported by improvement in Pro-C3 levels by 18.1 ng/mL and lipid biomarkers. Further reductions in leptin and urate levels were also significant (Table).Conclusions Once weekly utreglutide dosing for thirteen weeks in post-menopausal females with obesity was well tolerated and demonstrated reductions of body weight, liver fat, systolic and diastolic blood pressure, lipids, leptin and urate."

P1/2 data • Dyslipidemia • Genetic Disorders • Metabolic Dysfunction-Associated Steatotic Liver Disease • Obesity • APOB • LEP

IMPROVEMENT IN LIVER FAT CONTENT AND MASH BIOMARKERS WITH ONCE WEEKLY UTREGLUTIDE (GL0034), A GLUCAGON-LIKE PEPTIDE-1 RECEPTOR AGONIST IN SUBJECTS WITH MAFLD: A PHASE 1A/2B STUDY (AASLD 2025) - "Once weekly utreglutide dosing for 13 weeks in subjects with MAFLD was well tolerated and demonstrated marked reductions of body weight, liver fat, non-invasive fibrosis markers, liver enzymes, lipids along with leptin and urate."

Biomarker • Clinical • P1/2 data • Fibrosis • Genetic Disorders • Immunology • Metabolic Dysfunction-Associated Steatohepatitis • Metabolic Dysfunction-Associated Steatotic Liver Disease • Obesity • APOB • KRT18 • LEP

Metabolic and cardiovascular effects of 13-week utreglutide treatment in individuals with obesity and MASLD (EASD 2025) - P1/2 | "In individuals with obesity and MASLD, once weekly UTG dosing for 13 weeks was well-tolerated and demonstrated clinically relevant and robust changes in HbA1c, body weight and biomarkers of cardio-metabolism, which may confer additional cardiovascular benefits to individuals with type 2 diabetes along with obesity and MAFLD."

Clinical • Late-breaking abstract • Metabolic Disorders • Metabolic Dysfunction-Associated Steatotic Liver Disease • Obesity • Type 2 Diabetes Mellitus

Effects of Once-Weekly Utreglutide (GL0034) in Individuals with Overweight and Obesity on Lipid Metabolism—A 10-Week Exploratory Proof-of-Concept Study (ADA 2025) - "In individuals with overweight and obesity, once weekly UTG dosing for ten weeks, demonstrated clinically relevant changes in BW and biomarkers of cardio-metabolism with an overall good tolerability."

Clinical • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus • APOB • LEP

A Phase 1b/2a Randomized, Double-blind, Placebo Controlled, Parallel Group Study to Evaluate Efficacy, Safety, Tolerability and the Pharmacokinetics of GL0034 (Utreglutide) in the Treatment of Non-alcoholic Fatty Liver Disease (ANZCTR) - P1/2 | N=48 | Completed | Sponsor: International Sponsor: Sun Pharmaceutical Industries Ltd | Recruiting ➔ Completed

Trial completion • Hepatology • Metabolic Dysfunction-Associated Steatotic Liver Disease

A 10-week, randomized, double blind, placebo-controlled exploratory proof of concept study of Utreglutide (GL0034) in individuals with overweight and obesity (EASL 2025) - "Utreglutide was safe and well tolerated by individuals with overweight and obesity. The observed pharmacodynamic effects on liver enzymes and lipid profile, FLI along with body weight reduction at a total dose of 14.2 mg in 10-weeks, suggest potential therapeutic benefits in MASLD patients."

Clinical • Dyslipidemia • Gastrointestinal Disorder • Genetic Disorders • Hepatology • Liver Failure • Metabolic Dysfunction-Associated Steatotic Liver Disease • Obesity • APOB

India's Sun Pharma aims to launch its obesity drug in five years, managing director says (Reuters) - "India's largest drugmaker by revenue Sun Pharmaceutical (SUN.NS), opens new tab is aiming to launch its experimental anti-obesity and type 2 diabetes drug in the next four to five years, Managing Director Dilip Shanghvi said on Friday...Sun Pharma's novel investigational drug, also known as Utreglutide (GL0034), belongs to a drug class called GLP-1 receptor agonists, which suppress appetite by mimicking gut hormones and have also been found to have medical benefits for conditions beyond type 2 diabetes and weight loss...Sun Pharma, which expects to conduct mid-stage trials for the drug this year, earlier said it demonstrated clinically meaningful weight loss and significant metabolic improvements in the first phase of trials....Sun Pharma said in August it would consider a partnership or licensing the product in large markets such as the U.S. and Europe for commercialization."

Commercial • Launch non-US • New trial • Obesity • Type 2 Diabetes Mellitus

Once Weekly Utreglutide (GL0034), a Glucagon-like Peptide-1 Receptor Agonist, at 4 × 450 µg Doses Reduces Blood Pressure, Lipids, and Body Weight in Post-menopausal Females: A Phase I Study (AHA 2024) - "No significant changes were observed for TG, creatinine and potassium (Table).ConclusionsOnce weekly utreglutide dosing for four weeks at a dose of 450 µg in post-menopausal females with overweight and obesity, demonstrated clinically relevant reductions of systolic and diastolic BP. This was associated with improved performance of OGTT AUC of insulin and glucose, lipids, BW and leptin with an overall good tolerability and with potential to demonstrate cardio-metabolic benefits."

P1 data • Dyslipidemia • Gastrointestinal Disorder • Genetic Disorders • Metabolic Disorders • Obesity • LEP

Multiple Ascending Dose of the Novel GLP-1RA Utreglutide in Individuals With Obesity-A Phase I Study (OBESITY WEEK 2024) - "In individuals with obesity, once a week utreglutide dosing for four weeks, demonstrated clinically relevant reductions in BW, lipids, and leptin with an overall good tolerability."

Clinical • P1 data • Gastrointestinal Disorder • Genetic Disorders • Obesity • LEP

Safety, tolerability and metabolic effects of once weekly GL0034 (Utreglutide) in individuals with obesity: a multiple ascending dose study (EASD 2024) - "In individuals with obesity, once a week utreglutide dosing for four weeks, demonstrated clinically relevant reductions in glucose, insulin, HbA 1c , lipids and BW with an overall good tolerability."

Clinical • Metabolic Disorders • Obesity • LEP

Utreglutide (GL0034), a novel GLP-1RA, increases liver FGF-21 and demonstrates significant efficacy on weight loss, HbA 1c , and triglycerides in db/db mice (EASD 2024) - "Materials and We explored the effect of a fixed dose (21nmol/kg, s.c.) of GL0034, semaglutide (Sema) and tirzepatide (TZP) given to db/db mice [C57BL/KsJ-db/db male/female mice (age 8-10 weeks; body weight 45-65 g; n =8)] every third day for 4 weeks, randomised on the basis of HbA 1c levels. In conclusion, GL0034 showed robust efficacy on multiple metabolic parameters and may serve as a promising new super GLP-1RA for individuals with obesity +/- type 2 diabetes and for the treatment of metabolic dysfunction-associated steatotic liver disease (MASLD) with enhanced therapeutic benefits partly due to increased levels of liver FGF-21."

Preclinical • Diabetes • Metabolic Disorders • Metabolic Dysfunction-Associated Steatotic Liver Disease • Obesity • Type 2 Diabetes Mellitus • FGF21

GL0034 (Utreglutide), a Novel GLP-1RA, Increases Liver FGF-21 and Demonstrates Significant Efficacy on Weight Loss, HbA1c, and Triglycerides in db/db Mice (ADA 2024) - "Further, a single dose of subcutaneous administration of GL0034 in individuals with obesity resulted in 3.3 kg of weight loss that was sustained till day 22 We explored a fixed dose (21nM/kg) of GL0034, semaglutide (Sema) and tirzepatide (TZP) given to db/db mice every third day for 4 weeks. In Conclusion, GL0034 shows robust efficacy on multiple metabolic parameters and may serve as a promising new super GLP-1RA for individuals with obesity +/- type 2 diabetes and for the treatment of MASLD with enhanced therapeutic benefits partly due to increased liver FGF-21."

Preclinical • Diabetes • Metabolic Disorders • Metabolic Dysfunction-Associated Steatotic Liver Disease • Obesity • Type 2 Diabetes Mellitus • FGF21

Safety, Tolerability, and Metabolic Effects of Once-Weekly GL0034 (Utreglutide) in Individuals with Obesity—A Multiple Ascending Dose Study (ADA 2024) - "In individuals with obesity, once weekly GL dosing for four weeks, demonstrated clinically relevant reductions in glucose, insulin, HbA1c, lipids and BW with an overall good tolerability."

Clinical • Metabolic Disorders • Obesity

Sun Pharma's GL0034 (Utreglutide) Demonstrates Significant Weight Loss, Gluco-metabolic and Lipid Lowering Efficacy in Individuals with Obesity in Oral Presentation at the American Diabetes Association 84th Scientific Sessions (PRNewswire) - P1 | N=NA | "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. 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....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....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."

P1 data • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

GL0034 (Utreglutide), a long acting, glucagon-like peptide-1 receptor agonist, improves body weight loss, lipid and liver injury markers in individuals with obesity: A phase 1 multiple ascending dose study (EASL-ILC 2024) - "GL0034, a potent, long-acting GLP-1RA, was safe, well tolerated and with significant body weight reduction as well as improvements in lipids, liver injury and metabolic biomarkers in individuals with obesity. The observed PD effects suggest potential therapeutic benefits in MASLD patients."

Clinical • P1 data • Dyslipidemia • Gastrointestinal Disorder • Genetic Disorders • Hepatology • Liver Failure • Metabolic Dysfunction-Associated Steatotic Liver Disease • Obesity • LEP

A Phase 1b/2a Randomized, Double-blind, Placebo Controlled, Parallel Group Study to Evaluate Efficacy, Safety, Tolerability and the Pharmacokinetics of GL0034 (Utreglutide) in the Treatment of Non-alcoholic Fatty Liver Disease (ANZCTR) - P1/2 | N=48 | Recruiting | Sponsor: International Sponsor: Sun Pharmaceutical Industries Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • Hepatology • Metabolic Dysfunction-Associated Steatotic Liver Disease

A Phase 1b/2a Randomized, Double-blind, Placebo Controlled, Parallel Group Study to Evaluate Efficacy, Safety, Tolerability and the Pharmacokinetics of GL0034 (Utreglutide) in the Treatment of Non-alcoholic Fatty Liver Disease (ANZCTR) - P1/2 | N=48 | Not yet recruiting | Sponsor: International Sponsor: Sun Pharmaceutical Industries Ltd

New P1/2 trial • Hepatology • Metabolic Dysfunction-Associated Steatotic Liver Disease

A single ascending dose study of the novel GLP-1 receptor agonist GL0034 (utreglutide) in individuals with obesity without diabetes (EASD 2023) - "In conclusion, utreglutide at single dose demonstrated clinically relevant reductions in body weight in individuals with obesity and was well tolerated."

Clinical • Diabetes • Metabolic Disorders • Obesity • LEP

Safety and tolerability of multiple ascending doses of once-weekly GL0034 (utreglutide) in healthy individuals (EASD 2023) - "In conclusion, utreglutide was well tolerated and efficacious in healthy individuals with normal weight."

Clinical • Metabolic Disorders

Safety and Tolerability of Once-Weekly GL0034 (Utreglutide) in Healthy Individuals—A Multiple Ascending Dose Study (ADA 2023) - "Dose-dependent decreases in body weight were measured in cohorts 1, 2 and 3, respectively, compared to baseline, and were sustained through days 50 and 78. In conclusion, GL was well tolerated and efficacious in healthy individuals with normal weight."

Clinical • Metabolic Disorders

A Single Ascending Dose Study of the Novel GLP-1 Receptor Agonist GL0034 (Utreglutide) in Obese Individuals without Diabetes (ADA 2023) - "Reduction in body weight versus baseline reached a maximum of 3.3 kg with the 2,520 µg dose at day 8 and this effect was sustained through day 22 at every GL dose (Table). In conclusion, once-weekly GL demonstrated clinically relevant reductions in body weight in obese individuals and was well tolerated."

Clinical • Diabetes • Metabolic Disorders • Obesity • LEP