- 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.
- GL0034 exhibited a favorable tolerability profile, with
gastrointestinal (GI) adverse events consistent with those
typically observed in the incretin class.
- 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.
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. 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.
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.
GLP-1 (glucagon-like peptide-1) receptor agonists have emerged as a
promising therapeutic class for obesity.
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.
"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. "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."
"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. "We are
dedicated to advancing this innovative therapy to bring meaningful
benefits to patients worldwide."
GL0034 Oral Presentation at the ADA 2024 Scientific
Sessions
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]
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). The
results were as follows:
- 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.
- 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.
- HbA1c, leptin levels, and lipid levels (triglycerides, total
cholesterol, non-HDL cholesterol) were reduced in the treatment
cohorts.
GL0034 was well-tolerated with no treatment-related
discontinuations. The most common adverse events were
gastrointestinal, consistent with the incretin class profile.
The study was conducted in Belgium.
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. As a selective GLP-1 receptor agonist,
GL0034 shows potential for enhanced therapeutic benefits.
"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.
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. 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.
Disclaimer
Statements in this "Document" describing the Company's
objectives, projections, estimates, expectations, 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 or
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.
Logo -
https://mma.prnewswire.com/media/1581087/2998357/Sun_Pharma_Gray_Logo.jpg
View original
content:https://www.prnewswire.com/news-releases/sun-pharmas-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-302179558.html
SOURCE Sun Pharmaceutical Industries Limited