Ecnoglutide

Research overview

Key studies

1. Ji et al., Lancet Diabetes Endocrinol (NCT05813795) (2025)

   Multicentre, randomised, double-blind, placebo-controlled phase 3 trial, 40 weeks, 36 centres in China
   Model: Humans (664 Chinese adults with overweight or obesity, without diabetes)

   Least-squares mean body-weight change was -9.1%, -10.9% and -13.2% across three ascending once-weekly groups versus +0.1% with placebo; 77% to 87% versus 16% achieved at least 5% reduction; treatment-emergent adverse events occurred in 93% of each active group versus 84% with placebo.

2. EECOH-1, Nat Commun (NCT05680155) (2026)

   Multicentre, randomised, double-blind, placebo-controlled phase 3 monotherapy trial, 24 weeks, 32 centres in China
   Model: Humans (211 Chinese adults with type 2 diabetes)

   HbA1c fell by 1.96% and 2.43% in the two ecnoglutide groups versus 0.87% with placebo; estimated treatment differences were -1.09% and -1.56%.

3. EECOH-2, Lancet Diabetes Endocrinol (NCT05680129) (2025)

   52-week, multicentre, open-label, active-controlled non-inferiority phase 3 trial versus dulaglutide, 52 hospitals in China
   Model: Humans (623 Chinese adults with type 2 diabetes on metformin)

   HbA1c reductions at week 32 were 1.91% and 1.89% versus 1.65% with dulaglutide, meeting non-inferiority; the authors judged the statistically greater reduction in the higher ecnoglutide group not clinically relevant.

4. Zhu et al., Nat Commun (2024)

   Randomised, double-blind, placebo-controlled phase 2 trial
   Model: Humans (adults with type 2 diabetes)

   Reported efficacy and safety results supporting progression to phase 3; funded by the manufacturer.

5. Guo et al., Mol Metab (2023)

   Receptor signalling assays, rodent models, and a double-blind randomised placebo-controlled single and multiple ascending dose phase 1 study (NCT04389775)
   Model: Cells, animals (db/db mice, diet-induced obese rats) and humans (healthy participants)

   cAMP EC50 of 0.018 nM without receptor internalisation; greater body-weight reduction than semaglutide in rodents; steady-state half-life 124 to 138 hours, with decreased appetite, nausea and headache among adverse events.

6. Front Pharmacol drug-interaction study (NCT06335134) (2026)

   Open-label, fixed-sequence crossover interaction study
   Model: Humans (healthy participants)

   Reported that no dose adjustment is required for warfarin or metformin when coadministered with ecnoglutide.

Doses used in published trials

What investigators administered in the cited studies, recorded as a fact about those studies. Not a protocol and not a recommendation.

• No amounts are reproduced here. The phase 3 obesity trial (NCT05813795) randomised participants to three ascending once-weekly subcutaneous ecnoglutide groups or volume-matched placebo for 40 weeks ^2.
• EECOH-1 (NCT05680155) randomised participants to two ascending once-weekly subcutaneous ecnoglutide groups or volume-matched placebo for 24 weeks ^3.
• EECOH-2 (NCT05680129) randomised participants to two ascending once-weekly subcutaneous ecnoglutide groups or once-weekly dulaglutide, open-label, for 52 weeks ^4.
• The first-in-human study (NCT04389775) used single and multiple ascending once-weekly subcutaneous administration in healthy participants for up to 6 weeks ^6.

Published adverse-event data

Reported in the cited trials or product labels. Frequencies apply to the stated population and do not transfer to other settings.

• Treatment-emergent adverse events (any)
  93% in each of the three ecnoglutide groups versus 84% with placebo
  Phase 3 obesity trial, 664 adults, 40 weeks ² · Most common events were mild-to-moderate gastrointestinal events
• Discontinuation due to adverse events
  10 ecnoglutide-treated participants
  Phase 3 obesity trial, 40 weeks ² · Not further graded in the report
• Discontinuation due to adverse events
  3% (6 of 206) and 4% (8 of 208) in ecnoglutide groups versus 3% (6 of 207) with dulaglutide
  EECOH-2, type 2 diabetes on metformin, 52 weeks ⁴ · Not further graded in the abstract
• Decreased appetite, nausea, headache
  Reported among adverse events in the first-in-human study
  Phase 1, healthy participants, up to 6 weeks of once-weekly administration ⁶ · Not graded in the report

What is not known: Long-term outcomes, including cardiovascular outcomes, have not been reported in the sources reviewed. Whether the cAMP signalling bias produces any clinical advantage over established GLP-1 receptor agonists is unresolved; the one active-controlled trial met non-inferiority to dulaglutide and its authors judged the statistically greater HbA1c reduction not clinically relevant ^4. All pivotal trials were conducted in China in largely Chinese populations and funded by the manufacturer, and no non-Chinese regulatory approval was identified ^1,8. A head-to-head trial against semaglutide in obesity is registered but not reported in the sources reviewed ^10. Paediatric use is under study rather than established ^1,11.

Regulatory status

Status

Approved outside the United States. A 2026 review of its development reports first approval in China in January 2026 for glycaemic control in adults with type 2 diabetes, followed in March 2026 by approval in China for long-term weight management in adults with obesity, or with overweight plus at least one weight-related comorbidity, in combination with diet control and increased physical activity ^1. No Drugs@FDA application record was returned on 24 October 2026 ^8. No amounts are quoted anywhere in this entry because the Chinese national register document was not opened for this review.

United States (FDA)

Not approved in the United States; an openFDA Drugs@FDA query for ecnoglutide returned no application record on 24 October 2026 ^8.

Sport (WADA)

Not named individually in the sources reviewed ^13. Because approval status bears on the S0 class, and because this compound now has governmental approval in at least one jurisdiction, athletes should seek a ruling from their anti-doping organisation rather than inferring status from absence of a name ^13.

Status varies by country and changes over time. How we describe regulatory status.

References

1. Ecnoglutide: First Approvals Drugs. 2026
2. 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 Lancet Diabetes Endocrinol. 2025
3. 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 Nat Commun. 2026
4. 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 Lancet Diabetes Endocrinol. 2025
5. Efficacy and safety of GLP-1 analog ecnoglutide in adults with type 2 diabetes: a randomized, double-blind, placebo-controlled phase 2 trial Nat Commun. 2024
6. Discovery of ecnoglutide - A novel, long-acting, cAMP-biased glucagon-like peptide-1 (GLP-1) analog Mol Metab. 2023
7. Ecnoglutide (CID 162625103) PubChem. 2026
8. Drugs@FDA application data queried through openFDA for ecnoglutide (no matching application record returned on 24 October 2026) openFDA / Drugs@FDA. 2026
9. A Phase 3 Study to Evaluate the Efficacy of XW003 in Adults With Overweight or Obesity (NCT05813795) ClinicalTrials.gov. 2026
10. A Study to Compare XW003 Injection and Semaglutide Injection in Chinese Adults With Obesity (NCT07073417) ClinicalTrials.gov. 2026
11. A Study of XW003 Injection in Chinese Adolescents With Obesity (NCT07143227) ClinicalTrials.gov. 2026
12. No dose adjustment required for warfarin or metformin when coadministered with the novel GLP-1 receptor agonist ecnoglutide: an open-label, fixed-sequence, crossover study Front Pharmacol. 2026
13. International Standard: Prohibited List 2026 World Anti-Doping Agency. 2026