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T2DMPhase 3NCT05680129

A Phase 3 Study to Evaluate the Efficacy of XW003 Compared With Dulaglutide in Participants With T2DM

A Phase 3 study testing Ecnoglutide high dosage, Ecnoglutide low dosage and Dulaglutide in people with T2DM and Type 2 Diabetes Mellitus, run by Hangzhou Sciwind Biosciences Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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) Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
T2DM, Type 2 Diabetes Mellitus
What is being tested?
Ecnoglutide high dosage, Ecnoglutide low dosage and Dulaglutide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
623 participants
Where
1 siteChina
Study dates
10 Jan 2023to 12 Oct 2024
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • History of type 1 or other types of diabetes mellitus
  • Use of insulin during the 6 months preceding screening
  • History of proliferative diabetic retinopathy, diabetic maculopathy, diabetic neuropathy, or diabetic foot during the 6 months prior to 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • ZHONGSHAN Hospital

    Shanghai, Shanghai Municipality

Other trials in China

About this study

Official title: 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

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)

Read the detailed description

In this Phase 3 study, eligible participants will be randomized in a 1:1:1 ratio to receive once-weekly subcutaneous XW003 (high or dose) or active comparator dulaglutide as add-on to metformin treatment for 52 weeks, including a dose-escalation period.

Being tested
Ecnoglutide high dosage, Ecnoglutide low dosage, Dulaglutide, Metformin
Keywords
T2DM, Glucagon-like peptide-1, GLP-1, Ecnoglutide, XW003
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ecnoglutide high dosageDrug

    Also called XW003

    Administered subcutaneously

  • Ecnoglutide low dosageDrug

    Also called XW003

    Administered subcutaneously

  • DulaglutideDrug

    Administered subcutaneously

  • MetforminDrug

    Administered orally

Study groups in NCT05680129
Study groupRoleWhat they receive
B1: XW003+METExperimentalHigh dosage of XW003 once weekly
Receives: Drug: Ecnoglutide high dosage; Drug: Metformin
B2: XW003+METExperimentalLow dosage of XW003 once weekly
Receives: Drug: Ecnoglutide low dosage; Drug: Metformin
B3: Dulaglutide+METActive comparator1.5mg Dulaglutide once weekly
Receives: Drug: Dulaglutide; Drug: Metformin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline in HbA1c

    Measured: Baseline, week 32

Secondary outcomes (5)

  1. Change from baseline in HbA1c

    Measured: Baseline, Week 5, Week 9, Week 13, Week 17, Week 25, Week 43 and Week 52

  2. Change from baseline in fasting plasma glucose (FPG)

    Measured: Baseline, Week 32 and Week 52

  3. Change from baseline in lipid panel

    Measured: Baseline, Week 32 and Week 52

  4. Change from baseline in body weight

    Measured: Baseline, Week 32 and Week 52

  5. Pharmacokinetics: plasma trough level of XW003

    Measured: Baseline, Day 29, Day 57, Day 85, Day 224, Day 364 and Day 399

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jan 2023
  2. Study start10 Jan 2023
  3. Primary completion3 Jul 2024
  4. Study completion12 Oct 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
623 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05680129
Sponsor's protocol ID
SCW0502-1032
Status last verified
Jul 2023
First submitted
25 Dec 2022
Last updated
8 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • He Y, Mi N, Cheng Z, Xue H, Han J, Wang H, Wang H, Wu J, Shi X, Zhao S, Duan B, Zhu Y, Zhou Y, Li F, Wang X, Ling H, Wang S, Li Q, Jiang F, Yang M, Bing S, Zheng Q, Ning J, Guo M, Bu Y, Guan L, Li Y, Yang L, Guo W, Pan H, Li X. 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 Oct;13(10):863-873. doi: 10.1016/S2213-8587(25)00196-2. Epub 2025 Aug 22.

    PubMed 40854315

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ecnoglutide high dosage, Ecnoglutide low dosage and Dulaglutide in people with T2DM and Type 2 Diabetes Mellitus, run by Hangzhou Sciwind Biosciences Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in HbA1c (time frame: Baseline, week 32). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05680129, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2025.

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