Sun Pharmaceutical Industries Limited announced results from its Phase 1a/2b Study evaluating the tolerability, safety, pharmacokinetics and pharmacodynamics of GL0034, a novel long-acting GLP-1 receptor agonist, in post-menopausal females with obesity. The data were highlighted in poster presentation at the American Heart Association's (AHA) Scientific Sessions held from November 7-10, 2025, in New Orleans, USA. The Phase 1b/2a study in Australia evaluated weekly subcutaneous utreglutide in post-menopausal women with obesity and MAFLD (Metabolic Dysfunction-associated Fatty Liver Disease).
Participants experienced meaningful weight loss and waist circumference reduction, with a notable proportion achieving clinically significant outcomes compared to placebo. Additional metabolic improvements included improved systolic blood pressure, reduced liver fat, and favorable changes in biomarkers linked to fibrosis and insulin sensitivity. The treatment also lowered serum uric acid levels, reinforcing its potential in addressing multiple aspects of metabolic dysfunction in this high-risk population.
Once weekly utreglutide dosing for 13 weeks was well tolerated in post-menopausal female participants with obesity and MAFLD. The most frequent AEs were gastrointestinal in nature- nausea, diarrhoea, and vomiting - which is consistent with the incretin class. One participant had a serious Treatment-Emergent Adverse Event, which was unrelated to the treatment.
Further clinical studies are planned to assess clinical safety and efficacy. A Phase 1b/2a Study of The Novel GLP-1 Receptor Agonist GL0034 (utreglutide) in the Treatment of MASLD. [Moderated Digital Poster MP444, Saturday, November 8, 2025, 01:11pm 01:16pm CT, Population Science Zone, Moderated Digital Poster 11, Presented 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 17.6mg) or placebo for 13 weeks.
The data from strata of post-menopausal females (52-69 years of age) is presented (17 in GL0034 treatment and 5 in placebo). At Week 14, the GL0034-treated females achieved a mean percent change in body weight of -8%, (P<0.001) and sustained beyond initial treatment exposure through Week 17, compared to -2.1% at Week 14 and -1.2% at Week 17 in placebo-treated participants. Further, at week 14 and 17, 76% and 71% GL0034-treated female participants, respectively, achieved weight loss of more than 5%; and one fourth participants achieved a weight loss exceeding 10%.
The mean BMI at baseline of GL0034-treated females was 43 kg/m², which improved to 39.7 and 39.8 kg/m² at weeks 14 and 17, respectively. Notably, 47% of female participants in class III and class II obesity group, showed one level lowering of obesity class. The liver fat content was significantly decreased from baseline in participants treated with GL0034 with mean percent changes of -28.6% (P<0.01) compared to a change of -2.7% in placebo-treated individuals.
The PRO-C3 levels significantly decreased from baseline (-12.6%, P<0.05) as compared to an increase of 11.8% in placebo-treated participants. About 35% of the females achieved >30% of relative liver fat content reduction as compared to none in placebo-treated group. The most common AEs occurring in 5 participants receiving GL0034 were decreased appetite, early satiety, nausea, dyspepsia, and vomiting.
