utreglutide (GL0034) / Sun Pharma - LARVOL DELTA

Utreglutide (GL0034) Improves Body Weight, Body Composition and HbA1c in Adults With Type 2 Diabetes (OBESITY WEEK 2026) - No abstract available

Clinical • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Utreglutide (GL0034) shows comparable tolerability and efficacy with different dose escalation regimens in overweight and obese adults with type 2 diabetes (EASD 2026) - "Clinical Trial Registration Number: EU-CT 2024-513279-41-00 Background and aims: We present interim data from a double-blind, placebo-controlled study investigating tolerability and efficacy of GL0034, a novel glucagon-like peptide-1 receptor agonist, in T2DM on metformin and/or an SGLT2-inhibitor. GL0034 was well tolerated with two different dose-escalation regimens with maximum doses of 2.4 and 3.0 mg/week and led to pronounced improvements in body weight and glucose control in people with type 2 diabetes."

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

Durable cardiometabolic effects of Utreglutide (GL0034) in MASLD patients with non-diabetic and prediabetic status (EASD 2026) - "In individuals with obesity and MASLD, 13 weeks of once-weekly UTG dosing resulted in clinically meaningful improvements in cardiometabolic biomarkers. The data is indicative of potential for monthly dosing in patients with type 2 diabetes."

Clinical • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis • Metabolic Dysfunction-Associated Steatotic Liver Disease • Obesity • Type 2 Diabetes Mellitus • LEP

Utreglutide (GL0034) Shows Comparable Tolerability and Efficacy with Different Dose Escalation Regimens in Overweight and Obese Adults with Type 2 Diabetes (T2DM) (ADA 2026) - "Introduction and Objective: We present interim data from a double-blind, placebo-controlled study investigating tolerability and efficacy of GL0034, a novel glucagon-like peptide-1 receptor agonist, in T2DM on metformin and/or an SGLT2-inhibitor. GL0034 was well tolerated with two different dose-escalation regimens with maximum doses of 2.4 and 3.0 mg/week and led to pronounced improvements in body weight and glucose control in people with type 2 diabetes."

Clinical • Late-breaking abstract • Diabetes • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

Durable Cardiometabolic Effects of Utreglutide in Metabolic Dysfunction–Associated Steatotic Liver Disease Patients with Nondiabetic and Prediabetic Status (ADA 2026) - "In individuals with obesity and MASLD, 13 weeks of once-weekly UTG dosing resulted in clinically meaningful improvements in cardio-metabolic biomarkers. The data is indicative of potential for monthly dosing in T2D patients."

Clinical • Metabolic Disorders • Metabolic Dysfunction-Associated Steatotic Liver Disease • Obesity • LEP

Effect of utreglutide on cardio-metabolic and non-invasive fibrotic biomarkers in participants with metabolic-dysfunction associated steatotic liver disease (EASL 2026) - "Utreglutide well tolerated; robust and sustained reductions in BW and BMI were observed. Clinically meaningful changes in cardiometabolic biomarkers and NITs associated with metabolic liver disease were noted. Collectively, these findings highlight the potential of utreglutide as a therapeutic option for metabolic dysfunction-associated steatohepatitis (MASLD) and other obesity-related disorders."

Biomarker • Non-invasive • Fibrosis • Genetic Disorders • Hepatology • Liver Cirrhosis • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis • Metabolic Dysfunction-Associated Steatotic Liver Disease • Obesity

SP-GL0034-02: A Phase 2 Parallel Group Study in Adults with Type 2 Diabetes to evaluate Efficacy and Safety of GL0034 (clinicaltrialsregister.eu) - P1/2 | N=60 | Completed | Sponsor: Sun Pharmaceutical Industries Limited | Active, not recruiting ➔ Completed

Trial completion • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Study to Evaluate if Exposure to Drug is Impacted in Participants With Renal Insufficiency (clinicaltrials.gov) - P1 | N=40 | Recruiting | Sponsor: Sun Pharmaceutical Industries Limited | Not yet recruiting ➔ Recruiting

Enrollment open • Diabetes • Metabolic Disorders • Nephrology • Renal Disease • Type 2 Diabetes Mellitus

Efficacy and Safety of GL0034 in Overweight or Obese Adults With Type II Diabetes Mellitus (clinicaltrials.gov) - P2 | N=285 | Recruiting | Sponsor: Sun Pharmaceutical Industries Limited | Not yet recruiting ➔ Recruiting

Enrollment open • Diabetes • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

Study to Evaluate if Exposure to Drug is Impacted in Participants With Renal Insufficiency (clinicaltrials.gov) - P1 | N=40 | Not yet recruiting | Sponsor: Sun Pharmaceutical Industries Limited

New P1 trial • Diabetes • Metabolic Disorders • Nephrology • Renal Disease • Type 2 Diabetes Mellitus

SF-CSP-002: A Phase 2a double-blind, randomised, placebo-controlled, parallel group study to evaluate the efficacy, safety, tolerability and pharmacokinetics (PK) of GL0034 in adults with at-risk metabolic dysfunction-associated steatohepatitis (MASH) (ANZCTR) - P2 | N=60 | Recruiting | Sponsor: Sun Pharmaceuticals Ltd | Initiation date: May 2025

Trial initiation date • Hepatology • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis

Efficacy and Safety of GL0034 in Overweight or Obese Adults With Type II Diabetes Mellitus (clinicaltrials.gov) - P2 | N=285 | Not yet recruiting | Sponsor: Sun Pharmaceutical Industries Limited

New P2 trial • Diabetes • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

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