NCT05680155

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
211

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Dec 2022

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
4 days until next milestone

Study Start

First participant enrolled

December 29, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 11, 2023

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 12, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 12, 2024

Completed
Last Updated

September 10, 2025

Status Verified

July 1, 2023

Enrollment Period

1.5 years

First QC Date

December 25, 2022

Last Update Submit

September 3, 2025

Conditions

T2DMType 2 Diabetes Mellitus

Keywords

T2DMGlucagon-like peptide-1EcnoglutideXW003GLP-1

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in HbA1c

    Baseline, Week 24

Secondary Outcomes (13)

  • Change from baseline in HbA1c

    Baseline, Week 5, Week 9, Week 13, Week 17, Week 29, Week 33, Week 37, Week 45, Week 52

  • Proportion of subjects with HbA1c < 7% and HbA1c ≤6.5% after treatment

    week 24, week 52

  • Proportion of subjects with HbA1c < 7%, with no severe hypoglycemia or no weight gain

    week 24

  • Change from baseline in fasting plasma glucose (FPG)

    Baseline, Week 24 and Week 52

  • Change from baseline in fasting insulin

    Baseline, Week 24 and Week 52

  • +8 more secondary outcomes

Other Outcomes (3)

  • Incidence of adverse events

    from baseline to EOS

  • Pharmacokinetics: plasma trough level of XW003

    Baseline, D29, D57, D85, D168, D197, D225, D253, D364, D399

  • Immunogenecity of XW003

    Baseline, D85, D168, D253, D399

Study Arms (4)

C1-XW003

EXPERIMENTAL

High dosage of XW003 once weekly

Drug: Ecnoglutide

C1-Placebo

PLACEBO COMPARATOR

Matched Placebo once weekly

Drug: Placebo

C2-XW003

EXPERIMENTAL

Low dosage of XW003 once weekly

Drug: Ecnoglutide

C2-Placebo

PLACEBO COMPARATOR

Matched Placebo once weekly

Drug: Placebo

Interventions

EcnoglutideDRUG

Subcutaneous Injection

Also known as: XW003
C1-XW003C2-XW003
PlaceboDRUG

Subcutaneous Injection with matched volume

C1-PlaceboC2-Placebo

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 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.

You may not qualify if:

  • History of type 1 or other types of diabetes mellitus.
  • Use of any GLP-1 analogue during the 3 months preceding to screening.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, 210008, China

Location

Related Publications (1)

  • Zhu D, Wang W, Tong G, Ma J, Wen B, Zheng X, Shi B, Pang S, Wang K, Shi X, Zhang X, Fu L, Liu Y, Lu Y, Huang D, Jiang C, Pan T, Xue H, Han J, Ding H, Bing S, Jiang F, Zheng Q, Yang M, Guan L, Liu X, Ning J, Bu Y, Guo M, Yang L, Guo W, Li Y, Xu S, Pan H. Efficacy and safety of cAMP signalling-biased GLP-1 analogue ecnoglutide monotherapy versus placebo in patients with type 2 diabetes (EECOH-1): a multi-centre, randomised, double-blind, placebo-controlled, phase 3 trial. Nat Commun. 2026 Jan 7. doi: 10.1038/s41467-025-68165-7. Online ahead of print.

    PMID: 41501026DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Dalong Zhu

    The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
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

December 29, 2022

Primary Completion

June 12, 2024

Study Completion

October 12, 2024

Last Updated

September 10, 2025

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)