NCT05680129CompletedPhase 3
A Phase 3 Study to Evaluate the Efficacy of XW003 Compared With Dulaglutide in Participants With T2DM
A Phase 3, Multi-center, Open-label, Randomized Study to Evaluate the Efficacy and Safety of XW003 Versus Dulaglutide in Patients With T2DM Inadequately Controlled by Metformin
Source: ClinicalTrials.gov · Last updated 8 May 2025
Brief summary (registry, in English)
The aim of the study is to compare the efficacy and safety of two XW003 doses versus dulaglutide as add-on therapy to metformin in participants with type 2 diabetes mellitus (T2DM)
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 623 (actual)
- First submitted
- 25 Dec 2022
- Start date
- 10 Jan 2023
- Primary completion date
- 3 Jul 2024
- Lead sponsor
- Hangzhou Sciwind Biosciences Co., Ltd.
- Diseases
- Type 2 diabetes
- NCT number
- NCT05680129
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 623
- From 10 Jan 2023 to the primary completion date, 3 Jul 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of proliferative diabetic retinopathy, diabetic maculopathy, diabetic neuropathy, or diabetic foot during the 6 months prior to screening.
Other illness
- History of type 1 or other types of diabetes mellitus
- History of acute or chronic pancreatitis or high-risk factors for pancreatitis
- Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2.
- History of stomach surgeries or disorders associated with slowed emptying of the stomach during the past 6 months.
- History of heart attack, stroke or congestive heart failure of Grade 3 or 4 in the past 6 months.
Other
- Use of insulin during the 6 months preceding screening
Who the study is looking for
- Ability and willingness to participate in the study, give written informed consent, and comply with the study specific requirements and all protocol procedures
- Sex: male or female; Age: 18 to 75 years, inclusive
- BMI: 20.0 kg/m\^2 to 35.0 kg/m\^2, inclusive
- Have been diagnosed with T2DM for at least 3 months and treated with a stable dose of metformin (≥1500 mg/day) in addition to diet and exercise during the 8 weeks prior to screening.
- HbA1c ranging from 7.5% to 11.0% at screening, inclusive
- FPG ≤13.9 mmol/L at screening
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Zhongshan Hospital Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
Related publications
- 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 · PMID 40854315
This page is information, not medical advice. Discuss any trial with your doctor.