Obesity is a rapidly escalating global health crisis, contributing to a multitude of 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. Among the promising therapeutic options for obesity management is the use of GLP-1 (glucagon-like peptide-1) receptor agonists.
GL0034 (Utreglutide): A Differentiated Incretin Analogue
GL0034 (Utreglutide) is a novel differentiated incretin analogue with potent, long-acting agonist activity at the GLP-1 receptor. This cutting-edge compound is currently being investigated for its potential to offer significant clinical benefits beyond mere weight loss and gluco-metabolic improvements in obese individuals. 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.
Phase 1 Study Highlights Promising Results
Sun Pharmaceutical Industries Limited (Reuters: SUN.BO) (Bloomberg: SUNP IN) (NSE: SUNPHARMA) (BSE: 524715) (together with its subsidiaries and/or associate companies 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 recent findings from the GL0034 study have revealed promising results with considerable weight loss and substantial enhancements in lipid profiles among obese participants," stated Richard E. Pratley, MD, Medical Director at AdventHealth Diabetes Institute and Senior Investigator of the Diabetes Program at the Translational Research Institute. “This investigational therapy represents a potentially distinct asset in the field of weight management. The positive outcomes highlight the potential of this treatment and pave the way for further research and development.”
“The encouraging data from our GL0034 study underscore our dedication to combating the escalating global health crisis of obesity. These results not only show the effectiveness of GL0034 in achieving weight loss but also its promise in improving vital cardiometabolic parameters and risk factors,” said Dilip Shanghvi, Managing Director, Sun Pharma. “We are committed to advancing this innovative therapy to deliver meaningful benefits to patients around the world.”
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Study Design and Key Findings
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).
GL0034 was well-tolerated with no treatment-related discontinuations. 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.
Potential Therapeutic Benefits and Future Directions
"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.
Sun Pharma plans to initiate further trials to assess the efficacy of GL0034 across a range of indications. Data from the study was presented at the American Diabetes Association’s 84th Scientific Sessions meeting taking place in Florida from 21-24 June.
Sun Pharma's Commitment to Innovation
Sun Pharma proceeded into its first-in-human Phase 1 clinical trial based on positive results of its pre-clinical trials in which GL0034 demonstrated robust antidiabetic effects in mice, including reductions in blood glucose levels as well as body weight.
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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.
The Competitive Landscape of Weight-Loss Drugs
The global diabetes therapeutics market in 2024 continues to be reshaped by GLP-1 receptor agonists and next-generation insulin formulations. The dominance of incretin-based therapies underscores a clear industry shift toward multi-benefit, patient-centric treatments. Roche reported progress with several diabetes and obesity candidates which is becoming an exceedingly crowded therapeutic area that was a virtual desert prior to Novo Nordisk’s launch of liraglutide for weight loss 10 short ago. Since then, we have seen semaglutide and tirzepatide quickly achieve unimaginable success and now it seems virtually every pharmaceutical and biotech company is trying to copy Novo Nordisk and Lilly.
- Roche CT-388 (once-weekly injection dual GLP-1/GIP RA): CT-388 is currently being evaluated in phase 2 trials for people with obesity with (n=360) or without T2D (n=450), expected to complete in November and February 2026, respectively. Full phase 2 results for obesity will be available early 2026.
- Roche CT-868 (once-daily injection dual GLP-1/GIP RA): 16-week phase 2 trial (n=111) completed in July 2025. Phase 2 results are expected in 2026.
- Petrelintide (long-acting amylin analog): Two phase 2 trials are ongoing for people with overweight or obesity, one expected to complete in March 2026; and the other in June 2026.
Blockbuster weight-loss drugs such as Wegovy could soon become a lot cheaper - and reach more people - thanks to Chinese and Indian pharmaceutical companies. A long queue of companies is developing copies of the complex biological drugs, and some are racing to create modified or improved versions to compete in the global market.
“There is huge potential for companies from India, China, that can help create access to these drugs,” says Abhijit Zutshi, chief commercial officer of the pharmaceutical giant Biocon, headquartered in Bengaluru, India, who oversees its generics business and is based in Woodbridge, New Jersey.
These companies will “bring drugs to patients who need it, at a cost that can be afforded”, says Guy Rutter, a cell biologist at the University of Montreal, Canada.
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Biosimilars and the Future of Weight-Loss Drugs
One way that Indian and Chinese pharmaceutical companies plan to slash that price is by developing biosimilars, cheaper versions of expensive brand-name drugs. Unlike generics, which are exact copies of chemically synthesized branded drugs, biosimilars very closely resemble their reference product and are derived from modified living organisms, such as yeast.
Companies are preparing to release biosimilar versions of GLP-1 drugs when patent protections lift in different markets. In China, the patent for liraglutide has already expired, and the one for semaglutide will expire in 2026 in India and China.
Companies are also innovating in how they synthesize the drugs, fill the vials and manufacture the injection devices, says Zutshi, whose company is focusing on developing biosimilars for the global market.
No weight-loss biosimilars have yet been approved in India, but Glenmark Pharmaceuticals in Mumbai, India, launched Lirafit, a liraglutide biosimilar, in January for treating type 2 diabetes. Glenmark said in a press release that, at some 100 rupees a day (US$1.20), Lirafit costs 70% less than existing therapies. Biocon has also developed a liraglutide biosimilar, which was approved by the UK drug regulator for type 2 diabetes in March but their product is not on the market yet. Biocon says it is developing semaglutide biosimilars to launch in select countries as soon as 2026.
China’s drug administration has approved two GLP-1 drugs produced by Chinese companies for weight loss. The first is a liraglutide biosimilar marketed as Liluping, made by Huadong Medicine in Hangzhou. The second is beinaglutide, marketed as Feisumei by Benemae Pharmaceutical Corporation in Shanghai.
Several companies in China are ready to pounce on the semaglutide market as soon as the patents expire in 2026. Half a dozen companies have launched late-stage clinical trials of semaglutide injections. One of them, Hangzhou Jiuyuan Gene Engineering, has completed late-stage clinical trials for its semaglutide biosimilar for treatment of type 2 diabetes, and could be the first to enter the Chinese market. A pending court decision on whether the semaglutide patent applies in China could see these drugs enter the market even sooner. Late-stage trials for the company’s semaglutide biosimilar targeting weight loss are expected to start this year.
Improved Drugs and Novel Approaches
Beyond biosimilars, companies in India and China are also developing new obesity drugs. For example, Mumbai-based Sun Pharmaceuticals has developed a molecule called GL0034 that has slight tweaks to its chemistry that distinguish it from semaglutide and alter the way it interacts with insulin-secreting cells and nerve cells, says Rutter, who is a consultant for the company. “Not only is the ambition to have a cheaper product, but to have something which is as good, if not better” than semaglutide, he says.
Early-stage clinical trials of GL0034 have been “very encouraging”, says Rajamannar Thennati, executive vice-president for Sun Pharma, who is based in Vadodara, India. The results in three dozen participants show that high doses can lead to body-weight reductions of up to 10% after two months, according to a press release, but Thennati says it could take up to five years for the molecule to hit the market.
Sun Pharma is also in the early stages of developing a dual-target drug to compete with tirzepatide. Its structure is sufficiently different to be proprietary, says Rutter.
Another improved drug could arrive in the Chinese market even sooner. Innovent has partnered with Eli Lilly to develop a molecule called Mazdutide that mimics both GLP-1 and the glucagon hormone, which stimulates glucose production. Glucagon helps to increase metabolism and enhances fatty-tissue burning.
HDM1010: Unprecedented Combination Efficacy
HDM1010 may have unprecedented Combination Efficacy. Sun Pharma today announced results from two Phase 1 studies evaluating the tolerability, safety, pharmacokinetics and pharmacodynamics of GL0034, a novel long-acting GLP-1 receptor agonist, in non-obese and obese adults without diabetes.
In one of the studies, GL0034 reduced triglyceride levels and body weight by Day 8 after a single dose in obese individuals without diabetes. In the other study, GL0034 administered at multiple-ascending doses once weekly for up to 8 weeks was well tolerated and resulted in meaningful pharmacodynamic effects in healthy individuals with normal body weight. In this study, marked dose dependent reductions in body weight of up to 10.7% were observed following GL0034 treatment of relatively low doses for 4 to 8 weeks.
"The results of the Phase 1 trial of GL0034 are promising based on the safety and efficacy profile," said Richard E. Pratley, MD, Medical Director, AdventHealth Diabetes Institute and Senior Investigator, Diabetes Program Lead, Translational Research Institute. "GL0034 has a promising future in terms of weight loss and glycemic effects and based on these early results presented at ADA, GL0034 has a potential to be best in class.
"The rising incidence of obesity and diabetes places significant burden on global healthcare systems, and GLP-1 agonists have emerged as a useful option for treating these conditions with a single agent. We believe the Phase 1 data of Sun's GL0034 potentially differentiates it from approved therapies in its class. GL0034 was discovered and is being developed by Sun Pharma.
"These Phase 1 studies suggest a potential role for GL0034 as a unique candidate to provide therapeutic benefits for obese adults," said Rajamannar Thennati, MD, Lead Investigator and Executive Vice President, Research & Development, Sun Pharma.
Intestinal Excretion and Drug Clearance
As someone currently working in drug metabolism and hepatic clearance, learning about intestinal excretion feels like discovering a missing piece of the clearance puzzle. It’s fascinating to see how this pathway could influence our understanding of human PK and overall drug disposition. There’s still so much to explore- but that’s what makes it exciting! I’d love to hear from others in the ADME/PK and transporter space, do you think intestinal excretion deserves more focus in drug clearance studies?