Ecnoglutide (XW003) (5mg)
Ecnoglutide (XW003, Hangzhou Sciwind Biosciences) is a long-acting, cAMP-biased GLP-1 receptor agonist in clinical development. It is not approved by the FDA or EMA and has no regulatory approval. This page summarizes published Phase 1–3 evidence and laboratory reference calculations for a hypothetical 5 mg vial.
Reviewed by the AllPeptides.eu Editorial Team·Last reviewed: 2026-06-16
Educational information. Not medical advice, and no efficacy claim is implied. Regulatory approval is not a use recommendation by AllPeptides.eu.
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How It Works
Ecnoglutide is a long-acting GLP-1 analogue with cAMP-biased signaling. In vitro data in the Phase 1 publication showed potent cAMP production with an EC50 of 0.018 nM and no measurable GLP-1 receptor internalization up to an EC50 greater than 10 μM. In NCT04389775, its steady-state half-life was 124‚Äì138 hours, a pharmacokinetic finding that supported studying a weekly frequency in subsequent trials.
Quick Start
- Laboratory reconstitution reference: 3.0 mL bacteriostatic water ‚Üí approximately 1.67 mg/mL concentration.
- Phase 3 NCT05813795: The 1.2 mg, 1.8 mg, and 2.4 mg once-weekly arms were studied for 40 weeks versus volume-matched placebo.
- Concentration calculation: At 1.67 mg/mL, 1 unit = 0.01 mL ≈ 16.7 mcg on a U-100 scale.
- Generalizability limitation: NCT05813795 was conducted entirely at 36 centres in China, in a Chinese population without diabetes.
Phase 3 NCT05813795 arms — reference calculations (3 mL = ~1.67 mg/mL)
Route: Subcutaneous, as reported in the clinical trials | Frequency: Once weekly in Phase 3 NCT05813795
| Week | Dose | Units (per injection) |
|---|---|---|
| NCT05813795 — 40 weeks | 1.2 mg arm | 72 Units (0.72 mL) |
| NCT05813795 ‚Äî 40 weeks | 1.8 mg arm | 2 × 54 Units (0.54 mL) |
| NCT05813795 ‚Äî 40 weeks | 2.4 mg arm | 2 × 72 Units (0.72 mL) |
The table values are arms reported in NCT05813795, not a recommendation or dosing plan. Units and mL are exclusively mathematical conversions for the 5 mg / 3.0 mL reference concentration.
Reconstitution Steps
- For a laboratory reference calculation, 3.0 mL of bacteriostatic water corresponds to a concentration of approximately 1.67 mg/mL for a 5 mg vial.
- Gentle addition of solvent against the vial wall limits foaming.
- Gentle swirling continues until the lyophilized material is fully dissolved.
- Storage conditions are determined by the research-material protocol, not by approved product labeling.
- Cloudiness or particles are grounds for discarding the research solution.
Protocol Overview
- Compound: Ecnoglutide (XW003), Hangzhou Sciwind Biosciences' long-acting, cAMP-biased GLP-1 receptor agonist.
- Regulatory status: In clinical development; not approved by the FDA or EMA and has no regulatory approval.
- Phase 1 NCT04389775: Single ascending doses of 0.03–1.0 mg and multiple once-weekly doses of 0.2–0.6 mg for 6 weeks in healthy participants.
- Phase 2: 145 adults with type 2 diabetes, with once-weekly 0.4 mg, 0.8 mg, and 1.2 mg arms for 20 weeks.
- Phase 3 NCT05813795: 664 adults with overweight or obesity without diabetes, 40 weeks, at 36 centres entirely in China.
- Laboratory reference: 3.0 mL per hypothetical 5 mg vial (~1.67 mg/mL).
Dosing Protocol
- Phase 1 NCT04389775: The publication reports single ascending doses of 0.03–1.0 mg and multiple once-weekly doses of 0.2–0.6 mg for 6 weeks.
- Phase 2: The publication reports once-weekly 0.4 mg, 0.8 mg, and 1.2 mg arms for 20 weeks.
- Phase 3 NCT05813795: The publication reports once-weekly 1.2 mg, 1.8 mg, and 2.4 mg arms for 40 weeks versus volume-matched placebo.
- Phase 3 week-40 outcome: −9.1% (1.2 mg), −10.9% (1.8 mg), and −13.2% (2.4 mg), versus +0.1% with placebo.
- Interpretation: These are published outcomes from specific research arms, not instructions for use. The Phase 3 trial was conducted entirely in a Chinese population, and its findings should not be generalized beyond that population without additional evidence.
- Break between cycles: A 2–4 week break is recommended before repeating the cycle.
Washout & Cycle Restart
When can I restart?
After completing the cycle, a 2–4 week break is recommended before starting a new cycle. This allows the body to restore normal function and prevents potential downregulation (tachyphylaxis).
Storage Instructions
- There is no approved product labeling with standardized storage conditions for ecnoglutide.
- Storage and stability conditions depend on the specific research material and laboratory protocol.
Important Notes
- Ecnoglutide is an investigational compound and is not approved by the FDA or EMA.
- NCT05813795 enrolled a Chinese population entirely at 36 centres in China and does not establish automatic generalizability to other populations.
- NCT07387094, NCT07243171, and NCT07281937 are ongoing and their results have not been published.
- Numerical values on this page exclusively reproduce arms and outcomes from the cited trials.
Potential Benefits & Side Effects
Potential Benefits:
- Phase 3 NCT05813795: Least-squares mean bodyweight change at week 40 of −9.1% (1.2 mg), −10.9% (1.8 mg), and −13.2% (2.4 mg), versus +0.1% with placebo.
- Phase 3 NCT05813795: At least 5% bodyweight reduction was recorded in 77%, 84%, and 87% of the respective arms, versus 16% with placebo.
- Phase 2: HbA1c change of −1.81% (0.4 mg), −1.90% (0.8 mg), and −2.39% (1.2 mg), versus −0.55% with placebo.
- Phase 2, 1.2 mg arm: At least 5% bodyweight reduction in 33.3%, versus 3.0% with placebo.
- Limitation: The Phase 3 findings come exclusively from a Chinese population without diabetes.
Potential Side Effects:
- Phase 3 NCT05813795: Treatment-emergent adverse events in 93% of each ecnoglutide arm, versus 84% with placebo.
- The most common adverse events in NCT05813795 were mild-to-moderate gastrointestinal events.
- Ten participants in the ecnoglutide arms discontinued because of adverse events.
- The available safety evidence remains limited by the size, duration, and populations of the published trials.
⚠️ Serious Warnings & Long-Term Risks
The following warnings are based on published literature, FDA labels, and post-marketing surveillance. They do not constitute medical advice. Consult a healthcare professional.
Gastrointestinal tolerability under investigation
In Phase 3 NCT05813795, treatment-emergent adverse events were reported in 93% of each ecnoglutide arm, with ten discontinuations due to adverse events. The compound has not received regulatory approval.
📄 Lancet Diabetes Endocrinol Phase 3 — NCT05813795References
- The Lancet Diabetes & Endocrinology (2025) — Phase 3 NCT05813795 ‚Äî ecnoglutide in adults with overweight or obesity without diabetes
View Source - Nature Communications (2024) — Phase 2 ‚Äî ecnoglutide in adults with type 2 diabetes
View Source - Molecular Metabolism (2023) — Phase 1 NCT04389775 ‚Äî discovery and clinical evaluation of cAMP-biased XW003
View Source - ClinicalTrials.gov — Phase 3 obstructive sleep apnoea ‚Äî NCT07387094
View Source - ClinicalTrials.gov — Phase 1b/2a oral tablet formulation ‚Äî NCT07243171
View Source - ClinicalTrials.gov — Phase 2b weekly oral VRB-101 ‚Äî NCT07281937
View Source
External Sources & Regulatory Status
Regulatory Approvals
Research-only — not approved
Research-only — not approved
Research-only — Phase III, no regulatory approval
Educational information. Not medical advice, and no efficacy claim is implied. Regulatory approval is not a use recommendation by AllPeptides.eu.
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