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COMPLETEDPHASE3

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

A Phase 3, Multi-center, Double-blind, Randomized, Placebo-controlled Study to Evaluate the Efficacy and Safety of XW003 in Patients With T2DM Inadequately Controlled by Diet and Exercise Alone

NCT05680155•Hangzhou Sciwind Biosciences Co., Ltd.

View on ClinicalTrials.gov

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

Detailed 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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

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 months of 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 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, diabetic neuropathy, 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 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.

Locations (1)

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, China

Key Dates

Start Date

December 29, 2022

Primary Completion Date

June 12, 2024

Completion Date

October 12, 2024

Last Updated

September 10, 2025

Enrollment

211

ACTUAL participants

Conditions

T2DMType 2 Diabetes Mellitus

Interventions

Ecnoglutide

DRUG

Placebo

DRUG

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Type 1 Diabetes MellitusType 2 Diabetes Mellitus (T2DM)

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RECRUITINGNA

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NCT06887049

Type 2 Diabetes Mellitus (T2DM)Diabetes Distress

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 10, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Feasibility of a Tailored Online Self-compassion Intervention

Achieving Routine Intervention and Screening for Emotional Health

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