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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
Lead sponsor
Assets
Ecnoglutide (XW003) / Liraglutide
Listed sites
1
Recruiting sites
—
Enrollment
206
actual
Study population
Obesity / overweight
Key I/E criteria
•BMI 30-40•HbA1c ≤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
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
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
Weight & body composition
5 endpointsPercentage change in participants body weight (%) from the Baseline
Time frame:Week 26
Body weight, % change
percent change from baseline, improvement
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
Absolute change in body weight (kg) of participants
Time frame:Week 26
Body weight, absolute change (kg)
change from baseline, improvement
Changes in waist circumference and hip circumference (cm) in participants
Time frame:Week 26
Waist circumference, change
change from baseline, improvement
Change in BMI in participants
Time frame:Week 26
BMI, change
change from baseline, improvement
Glycemic / diabetes
3 endpointsChange in fasting plasma glucose (FPG)
Time frame:Week 26
Fasting glucose, change
change from baseline, improvement
LOINC 1558-6
Change in fasting serum insulin
Time frame:Week 26
change from baseline, improvement
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 endpointsChanges 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
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
Vital signs - participants' pulse rate change
Time frame:Week 26
Heart rate, change
change from baseline, improvement
Patient-reported / QoL
1 endpoint36-Item Short Form Survey (SF-36)
Time frame:Week 26
SF-36 total
change from baseline, improvement
Safety / tolerability / PK
8 endpointsNumber and severity of treatment-emergent adverse events (TEAEs)
Time frame:Week 26
Treatment-emergent AEs (any)
descriptive
Number and severity of new and ongoing gastrointestinal (GI) disorder (nausea, vomiting, diarrhea, and constipation) events by week
Time frame:Week 26
descriptive
Electrocardiograms (ECGs)
Time frame:Week 26
descriptive
Haematology, biochemistry, coagulation, and calcitonin
Time frame:Week 26
descriptive
Injection site reactions (ISRs)
Time frame:Week 26
event count, event
Physical examinations
Time frame:Week 26
descriptive
Plasma concentrations of XW003 on treatment
Time frame:Week 26
Plasma concentration (steady state)
concentration, descriptive
Anti-XW003 antibodies on treatment
Time frame:Week 26
Immunogenicity (ADA)
descriptive
Other (unclassified)
1 endpointVital signs - participants' ody temperature change
Time frame:Week 26
change from baseline, descriptive
Provenance
Sources
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.