A Phase 3 Study to Evaluate the Efficacy of XW003 Compared With Placebo in T2DM Patients

Last updated: September 3, 2025
Sponsor: Hangzhou Sciwind Biosciences Co., Ltd.
Overall Status: Completed

Phase

3

Condition

Hypertriglyceridemia

Diabetes Mellitus, Type 2

Treatment

Ecnoglutide

Placebo

Clinical Study ID

NCT05680155
SCW0502-1031
  • Ages 18-75
  • All Genders

Study 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

Eligibility Criteria

Inclusion

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 T2DMthat is inadequately controlled with at least 3 monthsof diet and exercise prior to screening.

  5. HbA1c ranging from 7.5% to 11.0% at screening, inclusive

  6. FPG ≤13.9 mmol/L at screening.

Exclusion

Exclusion Criteria:

  1. History of type 1 or other types of diabetes mellitus.

  2. Use of any GLP-1 analogue during the 3 months preceding to screening.

  3. History of proliferative diabetic retinopathy, diabetic maculopathy, diabeticneuropathy, or diabetic foot during the 6 months preceding 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 endocrineneoplasia syndrome type 2.

  6. History of stomach surgeries or disorders associated with slowed emptying of thestomach during the past 6 months.

  7. History of heart attack, stroke, or congestive heart failure of Grade 3 or 4 in thepast 6 months.

Study Design

Total Participants: 211
Treatment Group(s): 2
Primary Treatment: Ecnoglutide
Phase: 3
Study Start date:
December 29, 2022
Estimated Completion Date:
October 12, 2024

Study Description

In this Phase 3 study, eligible participants will be randomized in a 2:2:1:1 ratio to receive once-weekly subcutaneous XW003 (high or low dose) or volume matching placebo as an adjunct to lifestyle intervention for 24 weeks. The core treatment phase will be followed by a 28-week open-label period where all participants receive XW003.

Connect with a study center

  • Nanjing Drum Tower Hospital

    Nanjing, Jiangsu 210008
    China

    Site Not Available

  • Nanjing Drum Tower Hospital

    Nanjing 1799962, Jiangsu 1806260 210008
    China

    Site Not Available

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