Ecnoglutide: Trials and FDA Status
Ecnoglutide is a glp-1 agonist. This page tracks its trials, sponsor and FDA status, with a dated source for each milestone.
Medically reviewed by Juan Pablo Frías, MD · · DisclosureUpdated
Where it stands
- US status
- Investigational
- Phase
- Phase 3
- Sponsor
- Hangzhou Sciwind Biosciences
- Expected FDA decision
- None announced
- no primary source states a date (checked 2 Oct 2026)
- Trial IDs (NCT)
- NCT05111912, NCT05813795, NCT05680155, NCT05680129
Results
Reported results
- 2025Phase 3 in Chinese adults with overweight or obesity (Lancet Diabetes Endocrinol 2025): weight change at week 40“At week 40, the least-squares mean percentage change in bodyweight was -9·1% (SE 0·8) in the ecnoglutide 1·2 mg group, -10·9% (0·9) in the ecnoglutide 1·8 mg group, and -13·2% (0·8) in the ecnoglutide 2·4 mg group versus 0·1% (0·8) in the placebo group”pubmed.ncbi.nlm.nih.gov
- 2026Phase 3 in type 2 diabetes (2026): HbA1c change at week 24“At week 24, the least squares mean changes from baseline in HbA1c were -1.96% (95% CI -2.18 to -1.73) with ecnoglutide 0.6 mg and -2.43% (95% CI -2.65 to -2.20) with ecnoglutide 1.2 mg versus -0.87% (-1.09 to -0.65) with placebo.”pubmed.ncbi.nlm.nih.gov
Company-reported figures are labelled as such. Results in a trial population may not match results elsewhere.
Timeline
Milestones
- Published in Nature communications (2026): Efficacy and safety of cAMP signalling-biased GLP-1 analogue ecnoglutide monotherapy versus placebo in patients with type 2 diabetes (EECOH-1): a multi-centre, randomised, double-blind, placebo-controlled, phase 3 trial.
- Review in Drugs (2026) reports first approvals of ecnoglutide in China: type 2 diabetes (January 2026) and long-term weight management (March 2026)
- Published in The lancet. Diabetes & endocrinology (2025): Efficacy and safety of a biased GLP-1 receptor agonist ecnoglutide in adults with overweight or obesity: a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial.
- Published in The lancet. Diabetes & endocrinology (2025): Efficacy and safety of cAMP-biased GLP-1 receptor agonist ecnoglutide versus dulaglutide in patients with type 2 diabetes and elevated glucose concentrations on metformin monotherapy (EECOH-2): a 52-week, multicentre, open-label, non-inferiority, randomised, phase 3 trial.
- NCT05680129 (A Phase 3 Study to Evaluate the Efficacy of XW003 Compared With Dulaglutide in Participants With T2DM; Phase 3): primary completion
- NCT05813795 (A Phase 3 Study to Evaluate the Efficacy of XW003 in Adults With Overweight or Obesity; Phase 3): primary completion
- NCT05680155 (A Phase 3 Study to Evaluate the Efficacy of XW003 Compared With Placebo in T2DM Patients; Phase 3): primary completion
- Published in Nature communications (2024): Efficacy and safety of GLP-1 analog ecnoglutide in adults with type 2 diabetes: a randomized, double-blind, placebo-controlled phase 2 trial.
- NCT05813795 (A Phase 3 Study to Evaluate the Efficacy of XW003 in Adults With Overweight or Obesity; Phase 3): first posted on ClinicalTrials.gov
- NCT05813795 (A Phase 3 Study to Evaluate the Efficacy of XW003 in Adults With Overweight or Obesity; Phase 3): study start
- NCT05680155 (A Phase 3 Study to Evaluate the Efficacy of XW003 Compared With Placebo in T2DM Patients; Phase 3): first posted on ClinicalTrials.gov
- NCT05680129 (A Phase 3 Study to Evaluate the Efficacy of XW003 Compared With Dulaglutide in Participants With T2DM; Phase 3): first posted on ClinicalTrials.gov
- NCT05680129 (A Phase 3 Study to Evaluate the Efficacy of XW003 Compared With Dulaglutide in Participants With T2DM; Phase 3): study start
- NCT05680155 (A Phase 3 Study to Evaluate the Efficacy of XW003 Compared With Placebo in T2DM Patients; Phase 3): study start
- NCT05111912 (Effects of XW003 Versus Liraglutide on Body Weight of Adult Participants With Obesity; Phase 2): primary completion
- NCT05111912 (Effects of XW003 Versus Liraglutide on Body Weight of Adult Participants With Obesity; Phase 2): study start
- NCT05111912 (Effects of XW003 Versus Liraglutide on Body Weight of Adult Participants With Obesity; Phase 2): first posted on ClinicalTrials.gov
What people search
- ecnoglutide phase 310/mo
US monthly searches, Google Keyword Planner, Oct 2026. Shown so you can see which questions this page answers.
Sources
- 1Effects of XW003 Versus Liraglutide on Body Weight of Adult Participants With Obesity (NCT05111912)ClinicalTrials.gov (U.S. National Library of Medicine) · 2021clinicaltrials.govAccessed 2 Oct 2026
- 2A Phase 3 Study to Evaluate the Efficacy of XW003 in Adults With Overweight or Obesity (NCT05813795)ClinicalTrials.gov (U.S. National Library of Medicine) · 2023clinicaltrials.govAccessed 2 Oct 2026
- 3A Phase 3 Study to Evaluate the Efficacy of XW003 Compared With Placebo in T2DM Patients (NCT05680155)ClinicalTrials.gov (U.S. National Library of Medicine) · 2022clinicaltrials.govAccessed 2 Oct 2026
- 4A Phase 3 Study to Evaluate the Efficacy of XW003 Compared With Dulaglutide in Participants With T2DM (NCT05680129)ClinicalTrials.gov (U.S. National Library of Medicine) · 2022clinicaltrials.govAccessed 2 Oct 2026
- 5Efficacy and safety of GLP-1 analog ecnoglutide in adults with type 2 diabetes: a randomized, double-blind, placebo-controlled phase 2 trial.Nature communications · 2024PMID 39333121Accessed 2 Oct 2026
- 6Efficacy and safety of a biased GLP-1 receptor agonist ecnoglutide in adults with overweight or obesity: a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial.The lancet. Diabetes & endocrinology · 2025PMID 40555243Accessed 2 Oct 2026
- 7Efficacy and safety of cAMP-biased GLP-1 receptor agonist ecnoglutide versus dulaglutide in patients with type 2 diabetes and elevated glucose concentrations on metformin monotherapy (EECOH-2): a 52-week, multicentre, open-label, non-inferiority, randomised, phase 3 trial.The lancet. Diabetes & endocrinology · 2025PMID 40854315Accessed 2 Oct 2026
- 8Efficacy and safety of cAMP signalling-biased GLP-1 analogue ecnoglutide monotherapy versus placebo in patients with type 2 diabetes (EECOH-1): a multi-centre, randomised, double-blind, placebo-controlled, phase 3 trial.Nature communications · 2026PMID 41501026Accessed 2 Oct 2026
- 9Ecnoglutide: First Approvals.Drugs · 2026PMID 42412371Accessed 2 Oct 2026
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