NCT05680129

Brief 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)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
623

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 25, 2022

Completed
16 days until next milestone

Study Start

First participant enrolled

January 10, 2023

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 11, 2023

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 3, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 12, 2024

Completed
Last Updated

May 8, 2025

Status Verified

July 1, 2023

Enrollment Period

1.5 years

First QC Date

December 25, 2022

Last Update Submit

May 7, 2025

Conditions

T2DMType 2 Diabetes Mellitus

Keywords

T2DMGlucagon-like peptide-1GLP-1EcnoglutideXW003

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in HbA1c

    Baseline, week 32

Secondary Outcomes (5)

  • Change from baseline in HbA1c

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

  • Change from baseline in fasting plasma glucose (FPG)

    Baseline, Week 32 and Week 52

  • Change from baseline in lipid panel

    Baseline, Week 32 and Week 52

  • Change from baseline in body weight

    Baseline, Week 32 and Week 52

  • Pharmacokinetics: plasma trough level of XW003

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

Study Arms (3)

B1: XW003+MET

EXPERIMENTAL

High dosage of XW003 once weekly

Drug: Ecnoglutide high dosageDrug: Metformin

B2: XW003+MET

EXPERIMENTAL

Low dosage of XW003 once weekly

Drug: Ecnoglutide low dosageDrug: Metformin

B3: Dulaglutide+MET

ACTIVE COMPARATOR

1.5mg Dulaglutide once weekly

Drug: DulaglutideDrug: Metformin

Interventions

Ecnoglutide high dosageDRUG

Administered subcutaneously

Also known as: XW003
B1: XW003+MET
Ecnoglutide low dosageDRUG

Administered subcutaneously

Also known as: XW003
B2: XW003+MET
DulaglutideDRUG

Administered subcutaneously

B3: Dulaglutide+MET
MetforminDRUG

Administered orally

B1: XW003+METB2: XW003+METB3: Dulaglutide+MET

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ZHONGSHAN Hospital

Shanghai, Shanghai Municipality, China

Location

Related Publications (1)

  • 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.

    PMID: 40854315DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

dulaglutideMetformin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Study Officials

  • Xiaoying Li, Dr

    Shanghai Zhongshan Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 25, 2022

First Posted

January 11, 2023

Study Start

January 10, 2023

Primary Completion

July 3, 2024

Study Completion

October 12, 2024

Last Updated

May 8, 2025

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)