Current partner codePEPTIDESDE
NCT05680129·Phase 3·INTERVENTIONAL

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

Status

Completed

Phase

Phase 3

Enrollment

623

Locations

1

Results

Not posted

Publications

1

Study summary

What the protocol is testing.

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)

Full detailed description

In this Phase 3 study, eligible participants will be randomized in a 1:1:1 ratio to receive once-weekly subcutaneous XW003 (high or dose) or active comparator dulaglutide as add-on to metformin treatment for 52 weeks, including a dose-escalation period.

Interventions

Treatment arms and agents.

DRUG

Ecnoglutide high dosage

Administered subcutaneously

DRUG

Ecnoglutide low dosage

Administered subcutaneously

DRUG

Dulaglutide

Administered subcutaneously

DRUG

Metformin

Administered orally

Timeline

From registration to results.

  1. First posted

    Jan 11, 2023

  2. Study start

    Jan 10, 2023

  3. Primary completion

    Jul 3, 2024

  4. Study completion

    Oct 12, 2024

  5. Results posted

    Not reported

  6. Registry updated

    May 8, 2025

Outcomes

What the study measures.

Primary outcomes

Change from baseline in HbA1c

Time frame · Baseline, week 32

Secondary outcomes

Change from baseline in HbA1c

Time frame · Baseline, Week 5, Week 9, Week 13, Week 17, Week 25, Week 43 and Week 52

Change from baseline in fasting plasma glucose (FPG)

Time frame · Baseline, Week 32 and Week 52

Change from baseline in lipid panel

Time frame · Baseline, Week 32 and Week 52

Change from baseline in body weight

Time frame · Baseline, Week 32 and Week 52

Pharmacokinetics: plasma trough level of XW003

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

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
75 Years
Sex
ALL
Healthy volunteers
No

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.

Study locations

1 registered sites.

China. Showing up to 24 locations stored in the fast local snapshot.

ZHONGSHAN Hospital

Shanghai, Shanghai Municipality, China

Related trials

More studies on Dulaglutide.

Related PeptideStat pages

Put the record in context.

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