Skip to content
Calculator

Related guides: Starting a GLP-1 · WADA status for athletes

Evidence: LowPeptide Clinical Trials Pipeline & In-Development

Utreglutide

also known as: GL0034, GL-0034, Utreglutida

Sun Pharma's once-weekly GLP-1 receptor agonist, built on nearly the same chain as semaglutide. The only paper is a 2022 cell and mouse study; the human figures are the company's own phase 1 reports, and phase 2 trials in type 2 diabetes and fatty liver disease are recruiting.

Utreglutide (GL0034) is an injectable GLP-1 receptor agonist that Sun Pharmaceutical Industries discovered and is developing for weekly use in obesity, type 2 diabetes and fatty liver disease. In cells it bound the receptor more tightly than semaglutide and favoured the cAMP signal over pulling the receptor inside the cell, and in mice a lower dose matched semaglutide's weight and glucose effects (PMID 35676825). Sun Pharma reports weight loss in short phase 1 studies, such as 10.7% after eight weeks of rising doses in healthy adults; none of its human results is yet a peer-reviewed paper. A phase 2 trial in type 2 diabetes (NCT07282743) is recruiting. It is approved nowhere.

No dosing data yet Details ↓

Mechanism of action

Utreglutide switches on the GLP-1 receptor, the target of the gut hormone GLP-1 and of drugs such as semaglutide: activity there raises insulin release when glucose is high, slows stomach emptying and curbs appetite. Its chain is close to semaglutide's (FDA GSRS GSQ6ZZR8FG; our comparison: one extra leucine at the end and a slightly different linker to the fatty chain). In the discovery work, it bound the human receptor with higher affinity than semaglutide and was 'biased': for the amount of cAMP signal it produced, it caused less receptor uptake into the cell and less beta-arrestin-2 recruitment, two steps that switch the receptor's signal off. Insulin release from rat beta cells and from mouse and human islets was similar for the two drugs (PMID 35676825, cell and animal work). Whether the bias matters in people has not been tested in a published trial.

Primary uses

  • Investigational: type 2 diabetes with overweight or obesity (phase 2, recruiting)
  • Investigational: MASH, fatty liver disease with inflammation (phase 2a, recruiting)
  • Investigational: obesity (phase 1 and 1b/2a, company-reported)

Typical dosing

weekly in trials (subcutaneous)

No approved dose and no human dose in a peer-reviewed paper. Sun Pharma's releases give the amounts its phase 1 studies used (see the text above and the References); those are company reports of small trials, so no figure is printed here. The phase 2 trial lists six dose levels without amounts.

Regulatory status

Not approved anywhere: Drugs@FDA and the openFDA label endpoint hold no record for utreglutide or GL0034 (searched November 4, 2026), and ChEMBL records a highest clinical phase of 2 (CHEMBL5095156). Sun Pharma has reported four early studies through its own releases (2023 to 2025) and has three trials recruiting: a phase 2 trial in 285 adults with type 2 diabetes and overweight in the United States and India (NCT07282743, from January 2026), a single-dose kidney impairment study (NCT07385547, from February 2026) and a 24-week phase 2a trial in about 60 adults with MASH in Western Australia (ACTRN12625000241437, from May 2025).

Status as of this entry's last review, November 4, 2026. Approvals, compounding rules and sport rules change; the regulatory tracker is checked more often.

What the studies show

One paper on PubMed is about this molecule, the cell and mouse study below. Everything known about it in people comes from Sun Pharma's own releases on conference posters and talks, none yet a full peer-reviewed paper. In 2023 the company reported that single doses in 24 adults with obesity cut weight by about 2 to 2.5% within a week against a small gain on placebo, and that eight weeks of rising weekly doses in 36 lean, healthy adults brought a 10.7% loss at the top schedule; nausea, vomiting and loss of appetite were the commonest effects. In 2024 it reported four weekly doses in 24 men with obesity: the rising-dose group lost about 4.6 kg by day 29, with lower glucose and insulin on a sugar drink test. In 2025 it reported a 13-week phase 1b/2a trial of 48 adults with obesity and fatty liver in Australia, where the postmenopausal women in it lost 8% of their weight against 2.1% on placebo and about 29% of their liver fat against 3%, and a 10-week study in 20 adults in Belgium with 6.5% placebo-adjusted weight loss. Each figure is the company's, from small, short studies; reviews that only list the drug are in References.

Animal · 2022

Discovery paper: receptor tests in cells, islets and two mouse models

Sun Pharma and Imperial College London compared GL0034 with semaglutide. In cells carrying the human GLP-1 receptor it bound more tightly and leaned toward the cAMP signal, triggering less receptor uptake and less beta-arrestin-2 recruitment for the signal it gave. Insulin release from a rat beta-cell line and from mouse and human islets was about the same for both drugs. In diabetic db/db mice and in mice made obese by diet, repeated doses of 6 nmol/kg lowered weight and blood glucose at least as much as semaglutide at 14 nmol/kg. The authors call it a G protein-biased agonist worth testing in people with obesity and type 2 diabetes.

PMID 35676825

Registry · 2026

Phase 2 in type 2 diabetes with overweight, recruiting

Sun Pharma plans to enrol 285 adults whose type 2 diabetes is not controlled on metformin alone (HbA1c 7.0 to 10.5%) and whose BMI is 27 or more, at sites in the United States and India. After a stepwise climb of up to about 20 weeks, each person stays on one of the weekly doses or placebo. The main measure is the change in HbA1c at week 36; weight loss and the share reaching HbA1c targets are secondary. People who have used any GLP-1 drug are excluded. The record lists six dose levels but no amounts, and the trial started in January 2026.

NCT07282743 · ClinicalTrials.gov record

Registry · 2026

Kidney impairment study, recruiting

About 40 adults with normal kidney function, moderate or severe kidney impairment, or kidney failure on dialysis each receive one injection under the skin, and blood levels are followed for four weeks. The aim is to see whether weaker kidneys raise exposure to the drug and whether doses would need to change. It began in February 2026 at Florida sites and has not reported.

NCT07385547 · ClinicalTrials.gov record

References

  1. [pubmed] Jones B, et al. "In vivo and in vitro characterization of GL0034, a novel long-acting glucagon-like peptide-1 receptor agonist." Diabetes Obes Metab, 2022;24(11):2090-2101. PMID: 35676825.
  2. [pubmed] Park C, et al. "A glimpse into the pipeline of anti-obesity medication development: combining multiple receptor pathways." Front Endocrinol (Lausanne), 2025;16:1630199. PMID: 41019323.
  3. [pubmed] Wong S, et al. "Evaluating biased agonism of glucagon-like peptide-1 (GLP-1) receptors to improve cellular bioenergetics: A systematic review." Diabetes Obes Metab, 2025;27(11):6105-6115. PMID: 40726453.
  4. [clinicaltrials] ClinicalTrials.gov NCT07282743: "A Phase II, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Tolerability of GL0034 Among Type II Diabetes Mellitus Subjects Who Are Obese or Overweight With Weight-related Comorbidities" Sun Pharmaceutical Industries Limited. Phase 2, 285 planned adults with type 2 diabetes on metformin, HbA1c 7.0 to 10.5% and BMI of 27 or more, at 21 sites in the United States and India; weekly subcutaneous GL0034 at six listed dose levels (amounts not given) or placebo after up to about 20 weeks of titration; primary end point change in HbA1c at week 36. Recruiting since January 20, 2026; primary completion estimated April 2027; no results posted. Registry record read November 4, 2026.
  5. [clinicaltrials] ClinicalTrials.gov NCT07385547: "A Phase 1 Study to Assess the Effect of Renal Impairment on the Pharmacokinetics of GL0034" Sun Pharmaceutical Industries Limited. Open-label, one subcutaneous dose in about 40 adults with normal kidney function or moderate or severe impairment, with or without dialysis, blood levels followed for 672 hours; three Florida sites. Recruiting since February 25, 2026; no results posted. Registry record read November 4, 2026.
  6. [registry] Australian New Zealand Clinical Trials Registry ACTRN12625000241437: phase 2a, double-blind, randomised (2:1), placebo-controlled study of GL0034 (utreglutide) in adults with at-risk MASH, sponsor Sun Pharmaceuticals Ltd; weekly subcutaneous injections for 24 weeks with dose titration (amounts not stated), target 60 (35 enrolled at reading), first participant May 27, 2025; primary outcomes liver fat by MRI-PDFF and liver stiffness by MR elastography at week 24; Western Australia; recruiting. https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12625000241437. Read November 4, 2026.
  7. [manufacturer] Sun Pharmaceutical Industries. Press release filed with the NSE and BSE, June 24, 2023: "Sun Pharma Presents Data from First-in-Human Phase 1 Studies of GL0034 at the American Diabetes Association 83rd Scientific Sessions" (posters 765-P, single ascending doses in 24 adults with obesity, and 766-P, multiple ascending doses in 36 healthy adults; company statements). https://bseindia.com/xml-data/corpfiling/AttachHis/d598e690-44f5-4fb1-91ee-344a5a7f3521.pdf. Read November 4, 2026.
  8. [manufacturer] Sun Pharmaceutical Industries. Press release filed with the NSE and BSE, June 22, 2024: "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" (oral 121-OR; 24 men with obesity in Belgium, four weekly doses; company statements). https://bseindia.com/xml-data/corpfiling/AttachHis/fca142df-1a59-447b-b8f1-974a5b9dd743.pdf. Read November 4, 2026.
  9. [other] Healio Endocrinology, January 17, 2025: "Novel GLP-1 analog utreglutide confers weight loss, improves leptin resistance" (report of Sun Pharma's ObesityWeek 2024 presentation of the four-dose phase 1 study in 24 men, giving the weight changes in kilograms and the leptin changes). https://www.healio.com/news/endocrinology/20250117/novel-glp1-analog-utreglutide-confers-weight-loss-improves-leptin-resistance. Read November 4, 2026.
  10. [manufacturer] Sun Pharmaceutical Industries. Press release, November 12, 2025: "Sun Pharma Presents Two Posters on Utreglutide at ObesityWeek 2025" (a phase 1b/2a subgroup with class III obesity and fatty liver in Australia, and a 10-week study in 20 adults without diabetes in Belgium; company statements). https://sunpharma.com/wp-content/uploads/2025/11/PR-OW-25.pdf. Read November 4, 2026.
  11. [manufacturer] Sun Pharmaceutical Industries. Press release, November 12, 2025: "Sun Pharma Presents Data from Phase 1b/2a Study of GL0034 at the American Heart Association 2025 Scientific Sessions" (poster MP444; postmenopausal women in the 48-person phase 1b/2a; company statements). https://sunpharma.com/wp-content/uploads/2025/11/PR-AHA-25.pdf. Read November 4, 2026.
  12. [other] FDA Global Substance Registration System, Utreglutide, UNII GSQ6ZZR8FG (protein; INN 12030, CAS 2460862-12-6, NCI Thesaurus C188578; codes GL0034 and GL-0034), read November 4, 2026: the 32-residue chain HAEGTFTSDVSSYLEGQAAKEFIAWLVRGRGL with 2-methylalanine at position 2 and, on the lysine at position 20, a 17-carboxyheptadecanoyl chain on gamma-glutamyl, 2-methylalanyl and aminoethoxy-ethoxy-acetyl linkers. https://gsrs.ncats.nih.gov/ginas/app/beta/substances/GSQ6ZZR8FG
  13. [other] ChEMBL molecule CHEMBL5095156 (UTREGLUTIDE), read November 4, 2026: molecule type Protein, synonyms Utreglutide (INN), Utreglutida; INN stems -tide and -treg-; highest clinical phase recorded 2. https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL5095156/
  14. [other] US FDA, Drugs@FDA and the drug label endpoint (openFDA), searched November 4, 2026: no application and no label record for utreglutide or GL0034.

Related peptides

Semaglutide

A once-weekly GLP-1 receptor agonist FDA-approved for type 2 diabetes and chronic weight management.

Ecnoglutide

Sciwind's once-weekly, cAMP-biased GLP-1 analogue (half-life 124-138 h): approved in China for type 2 diabetes (January 2026) and chronic weight management (March 2026) after phase 3 trials, including 13.2% weight loss at 40 weeks. Not FDA- or EMA-approved.

GLP-1

The gut hormone every GLP-1 drug copies: it raises insulin only when glucose is high, slows the stomach and curbs appetite, and DPP-4 destroys it in about two minutes.

Bofanglutide

A long-acting GLP-1 agonist tested every two weeks; adults with obesity lost 9.8% to 16.7% of body weight over 30 weeks in a phase 2b trial.

Liraglutide

The first once-daily GLP-1 analog to be FDA-approved for both type 2 diabetes (Victoza) and chronic weight management (Saxenda).

Tirzepatide

A once-weekly GLP-1/GIP dual agonist that produced unprecedented weight loss in SURMOUNT trials — up to ~21% at highest dose.

Guides & tools

Disclaimer

This entry is for educational purposes only and does not constitute medical advice. Dosing information reflects published regulatory or research data and is not a recommendation. Many compounds described here are not approved for human use in the United States. Consult a licensed medical professional before considering any peptide therapy.