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Trial · Interventional

CompletedPhase 3Registry data

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

NCTNCT05680129 (opens ClinicalTrials.gov in a new tab)Other idSCW0502-1032
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
623 participants (actual)
Sponsor
Hangzhou Sciwind Biosciences Co., Ltd. · Industry
Design
Randomized · Open label (no masking)
Countries
1 country

China

Start
10 Jan 2023
Primary completion
3 Jul 2024
Completion
12 Oct 2024
First posted
11 Jan 2023
Last update posted
8 May 2025
Conditions
T2DM · Type 2 Diabetes Mellitus

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
202320242025
  1. Ph 3

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

    NCT05680129

    10 Jan 2023 to 12 Oct 2024

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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)

Interventions

  • Ecnoglutide high dosageDrug
  • Ecnoglutide low dosageDrug
  • DulaglutideDrug
  • MetforminDrug

Arms3

  • Experimental

    B1: XW003+MET

    High dosage of XW003 once weekly

  • Experimental

    B2: XW003+MET

    Low dosage of XW003 once weekly

  • Active comparator

    B3: Dulaglutide+MET

    1.5mg Dulaglutide once weekly

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change from baseline in HbA1c

    Time frame · Baseline, week 32

Secondary outcomes(5)

  1. Change from baseline in HbA1c

    Time frame · 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)

    Time frame · Baseline, Week 32 and Week 52

  3. Change from baseline in lipid panel

    Time frame · Baseline, Week 32 and Week 52

  4. Change from baseline in body weight

    Time frame · Baseline, Week 32 and Week 52

  5. Pharmacokinetics: plasma trough level of XW003

    Time frame · Baseline, Day 29, Day 57, Day 85, Day 224, Day 364 and Day 399

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2025

5 results

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.

He et al. 2025The lancet. Diabetes & endocrinologycited by 10

PMID 40854315DOI 10.1016/s2213-8587(25)00196-2PUB-40854315

Full text at the publisher5 results
Publisher pageSee results (5)

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 75 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: 1. Ability and willingness to participate in the study, give written informed consent, and comply with the study specific requirements and all protocol procedures 2. Sex: male or female; Age: 18 to 75 years, inclusive 3. BMI: 20.0 kg/m\^2 to 35.0 kg/m\^2, inclusive 4. 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. 5. HbA1c ranging from 7.5% to 11.0% at screening, inclusive 6. FPG ≤13.9 mmol/L at screening Exclusion Criteria: 1. History of type 1 or other types of diabetes mellitus 2. Use of insulin during the 6 months preceding screening 3. History of proliferative diabetic retinopathy, diabetic maculopathy, diabetic neuropathy, or diabetic foot during the 6 months prior to screening. 4. History of acute or chronic pancreatitis or high-risk factors for pancreatitis 5. Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2. 6. History of stomach surgeries or disorders associated with slowed emptying of the stomach during the past 6 months. 7. History of heart attack, stroke or congestive heart failure of Grade 3 or 4 in the past 6 months.

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