← Trials/Trial dossier/NCT05111912

CompletedPhase 2

Effects of XW003 Versus Liraglutide on Body Weight of Adult Participants With Obesity

A Phase 2, Open-label, Randomised, Dose-Finding Study of XW003, Once-Weekly Human Glucagon-Like Peptide 1 Analogue, Compared With Once-Daily Liraglutide 3 mg in Adult Participants With Obesity

Assets

Ecnoglutide (XW003) / Liraglutide

Listed sites

1

Recruiting sites

Enrollment

206

actual

Study population

Obesity / overweight

Key I/E criteria

BMI 30-40HbA1c ≤6.5%

Primary endpoint

Body weight, % change

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT05111912
Org study IDSCW0502-1121

Timeline

Milestones

Study first posted2021-11-08actual
Study start2021-11-30actual
Primary completion2022-11-16actual
Study completion2022-12-20actual
Last update posted2023-08-21actual

Assets

Investigational agents

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
Maximum age70 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

To be eligible for this study, a participant has to meet all of the following inclusion criteria:

1. Male or female, aged 18 to 70 years (inclusive at the time of informed consent);

2. Participants must have a BMI ≥ 30.0 kg/m2 and ≤40.0 kg/m2 at Screening;

3. Participants must have a stable body weight for at least 3 months prior to Screening (<5% change, self-reported);

4. Participants must have glycated haemoglobin (HbA1c) level <6.5% at Screening;

5. Women of childbearing potential (WOCBP) must be non-pregnant and must use an acceptable, highly effective contraception from Screening until the study completion, including the follow-up period.

6. Participants must have the ability and willingness to attend the necessary visits to the clinical research unit (CRU);

7. Participants must be willing and able to provide written informed consent after the nature of the study has been explained and prior to the commencement of any study procedures.

Exclusion criteria

A participant who meets any of the following exclusion criteria must be excluded from the study:

1. Diagnosis of type 2 (HbA1c ≥6.5%) or other types of diabetes mellitus;

2. Obesity induced by endocrine disorders (e.g., Cushing syndrome);

3. Calcitonin ≥50 ng/L (pg/mL) at Screening;

4. History of severe allergic or hypersensitivity to any of the investigational products or its excipients or to drugs of similar chemical classes;

5. History of cerebral stroke (including but not limited to cerebral infarction/haemorrhage) within 6 months prior to Screening;

6. History of acute coronary syndrome (angina pectoris and/or myocardial infarction) and any other major cardiac conditions (including but not limited to myocarditis, cardiac insufficiency/failure, and any clinically significant arrythmia[s]) within 6 months prior to Screening;

7. Impaired liver function defined as alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >5 times upper limit of normal (ULN) at Screening;

Main Inclusion Criteria:

To be eligible for this study, a participant has to meet all of the following inclusion criteria:

1. Male or female, aged 18 to 70 years (inclusive at the time of informed consent);

2. Participants must have a BMI ≥ 30.0 kg/m2 and ≤40.0 kg/m2 at Screening;

3. Participants must have stable body weight for at least 3 months prior to Screening (<5% change, self-reported);

4. Participants must have glycated hemoglobin (HbA1c) level <6.5% at Screening;

5. Women of childbearing potential (WOCBP) must be non-pregnant and must use an acceptable, highly effective contraception from Screening until the study completion, including the follow-up period.

6. Participants must have the ability and willingness to attend the necessary visits to the clinical research unit (CRU);

7. Participants must be willing and able to provide written informed consent after the nature of the study has been explained and prior to the commencement of any study procedures.

Main Exclusion Criteria:

A participant who meets any of the following exclusion criteria must be excluded from the study:

1. Diagnosis of type 2 (HbA1c ≥6.5%) or other types of diabetes mellitus;

2. Obesity induced by endocrine disorders (e.g., Cushing syndrome);

3. Calcitonin ≥50 ng/L (pg/mL) at Screening;

4. History of severe allergic or hypersensitivity to any of the investigational products or its excipients or to drugs of similar chemical classes;

5. History of cerebral stroke (including but not limited to cerebral infarction/haemorrhage) within 6 months prior to Screening;

6. History of acute coronary syndrome (angina pectoris and/or myocardial infarction) and any other major cardiac conditions (including but not limited to myocarditis, cardiac insufficiency/failure, and any clinically significant arrythmia[s]) within 6 months prior to Screening;

7. Impaired liver function defined as alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >5 times upper limit of normal (ULN) at Screening;

8. Estimated glomerular filtration rate (eGFR), calculated using the modified diet in renal disease (MDRD) formula < 60 mL/min/1.73m2;

9. History of acute or chronic pancreatitis or defined as amylase >ULN at Screening;

10. Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2 (MEN2);

11. Positive infection with human immunodeficient virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV);

12. History of primary or recurrent malignancy, except for non-melanoma skin cancer excised more than 2 years prior to Screening;

13. History of clinically significant endocrine condition(s);

14. History of major depressive disorder within 2 years before randomisation;

15. History of surgical treatment for obesity;

16. Having been exposed to any GLP-1 analogues within 6 months before Screening;

17. Treatment with orlistat, zonisamide, topiramate, phentermine, lorcaserin, bupropion and naltrexone alone or in combination or any other medications that could promote weight loss within 90 days prior to Screening;

18. Use of any other investigational products or medical devices within 3 months prior to Screening;

19. Participation in any medical (e.g., assisted by a clinical dietician or nutritionist) or non-medical (e.g., by a gym coach) diet and/or exercise program within 3 months prior to Screening and for the duration of the study (including the follow-up period);

20. Known or suspected abuse of alcohol or recreational drugs;

21. Being pregnant or lactating at Screening or planning to become pregnant (self or female partner) at any time during the study and for at least 3 months after the last dose of study drug;

22. Presence of any underlying physical and/or psychological medical condition that, in the opinion of the investigator, would make it unlikely that the participant will comply with the protocol or complete the study per protocol.

Endpoints (21)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Safety / tolerability / PK
8
Weight & body composition
5
Glycemic / diabetes
3
Cardiometabolic biomarkers
3
Patient-reported / QoL
1
Other (unclassified)
1

Weight & body composition

5 endpoints
Primary/protocol endpoint

Percentage change in participants body weight (%) from the Baseline

Time frame:Week 26

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Proportions of participants with body weight loss ≥5%, ≥10% and ≥15% of the Baseline

Time frame:Week 26

≥15% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Absolute change in body weight (kg) of participants

Time frame:Week 26

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Changes in waist circumference and hip circumference (cm) in participants

Time frame:Week 26

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint

Change in BMI in participants

Time frame:Week 26

BMI, change

change from baseline, improvement

Glycemic / diabetes

3 endpoints
Secondary/protocol endpoint

Change in fasting plasma glucose (FPG)

Time frame:Week 26

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint/low confidence

Change in fasting serum insulin

Time frame:Week 26

change from baseline, improvement

Secondary/protocol endpoint

Change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)

Time frame:Week 26

HOMA-IR (insulin sensitivity)

change from baseline, improvement

Cardiometabolic biomarkers

3 endpoints
Secondary/protocol endpoint

Changes in fasting lipids (triglyceride, low-density lipoprotein [LDL], and high-density lipoprotein [HDL])

Time frame:Week 26

change from baseline, improvement

componentsTriglycerides, change, LDL-C, change, HDL-C, change

Secondary/protocol endpoint

Vital signs - participants' blood pressure change

Time frame:Week 26

Systolic BP, change

change from baseline, improvement

componentsSystolic BP, change, Diastolic BP, change

LOINC 8480-6

Secondary/protocol endpoint

Vital signs - participants' pulse rate change

Time frame:Week 26

Heart rate, change

change from baseline, improvement

Patient-reported / QoL

1 endpoint
Secondary/protocol endpoint

36-Item Short Form Survey (SF-36)

Time frame:Week 26

SF-36 total

change from baseline, improvement

Safety / tolerability / PK

8 endpoints
Secondary/protocol endpoint

Number and severity of treatment-emergent adverse events (TEAEs)

Time frame:Week 26

Treatment-emergent AEs (any)

descriptive

Secondary/protocol endpoint

Number and severity of new and ongoing gastrointestinal (GI) disorder (nausea, vomiting, diarrhea, and constipation) events by week

Time frame:Week 26

descriptive

Secondary/protocol endpoint

Electrocardiograms (ECGs)

Time frame:Week 26

descriptive

Secondary/protocol endpoint

Haematology, biochemistry, coagulation, and calcitonin

Time frame:Week 26

descriptive

Secondary/protocol endpoint

Injection site reactions (ISRs)

Time frame:Week 26

event count, event

Secondary/protocol endpoint

Physical examinations

Time frame:Week 26

descriptive

Other/protocol endpoint

Plasma concentrations of XW003 on treatment

Time frame:Week 26

Plasma concentration (steady state)

concentration, descriptive

Other/protocol endpoint

Anti-XW003 antibodies on treatment

Time frame:Week 26

Immunogenicity (ADA)

descriptive

Other (unclassified)

1 endpoint
Secondary/protocol endpoint/low confidence

Vital signs - participants' ody temperature change

Time frame:Week 26

change from baseline, descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.