NCT05680155CompletedPhase 3
A Phase 3 Study to Evaluate the Efficacy of XW003 Compared With Placebo in T2DM Patients
A Phase 3, Multi-center, Double-blind, Randomized, Placebo-controlled Study to Evaluate the Efficacy and Safety of XW003 in Patients With T2DM Inadequately Controlled by Diet and Exercise Alone
Source: ClinicalTrials.gov · Last updated 10 Sept 2025
Brief summary (registry, in English)
The main purpose of this study is to investigate the efficacy and safety of XW003 versus placebo in patients with type 2 diabetes mellitus (T2DM) inadequately controlled by diet and exercise alone
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 211 (actual)
- First submitted
- 25 Dec 2022
- Start date
- 29 Dec 2022
- Primary completion date
- 12 Jun 2024
- Lead sponsor
- Hangzhou Sciwind Biosciences Co., Ltd.
- Diseases
- Type 2 diabetes
- NCT number
- NCT05680155
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 211
- From 29 Dec 2022 to the primary completion date, 12 Jun 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.
Other illness
- History of type 1 or other types of diabetes mellitus.
- History of proliferative diabetic retinopathy, diabetic maculopathy, diabetic neuropathy, or diabetic foot during the 6 months preceding screening.
- 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 any GLP-1 analogue during the 3 months preceding to 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 T2DMthat is inadequately controlled with at least 3 months of diet and exercise 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 |
|---|---|---|---|
| Nanjing Drum Tower hospital Coordinator of this site? Confirm its status | Nanjing | China | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.