Weight ManagementPhase 3NCT05813795
A Phase 3 Study to Evaluate the Efficacy of XW003 in Adults With Overweight or Obesity
A Phase 3 study testing Ecnoglutide Low Dosage, Ecnoglutide Medium Dosage and Ecnoglutide High Dosage in people with Weight Management, run by Hangzhou Sciwind Biosciences Co., Ltd. at 1 site in China.
Trial summary
The aim of the study is to evaluate the efficacy and safety of XW003 versus placebo in adults with overweight or obesity Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Weight Management
- What is being tested?
- Ecnoglutide Low Dosage, Ecnoglutide Medium Dosage and Ecnoglutide High Dosage
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 664 participants
- Where
- 1 siteChina
- Study dates
- 5 Apr 2023to 10 Oct 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, 18-75 years old, inclusive;
- BMI between 24.0 to 28.0 kg/m2 with at least one comorbidity, including prediabetes, hypertension, hyperlipidemia, fatty liver , obstructive sleep apnea syndrome, etc.; or BMI ≥ 28 kg/m2 with or without comorbidities.
- Weight change of no more than 5% (based on self-report), with diet and exercise alone, within 3 months before screening.
- Willing and able to maintain stable diet and exercise during the study period.
Who cannot join
- Obesity induced by endocrine diseases such as hypothyroidism, Cushing Syndrome, etc.
- History of bariatric surgery (except liposuction >1 year ago) or planned bariatric surgery during the study period.
- Within 3 months before screening, history of using the following drugs or treatments:
- Any approved or unapproved weight-loss drugs or Chinese herbs or health products that affect body weight.
- Any hypoglycemic medication.
- Any medication that may cause significant weight gain, including systemic glucocorticoid treatment, tricyclic anti-depressants, anti-epileptic and antipsychotics.
- Any investigational drug, vaccine, or medical device.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 3, Multi-center, Randomized, Double-Blind and Placebo-controlled Study to Evaluate the Efficacy and Safety of XW003 in Adults With Overweight or Obesity (SLIMMER)
The aim of the study is to evaluate the efficacy and safety of XW003 versus placebo in adults with overweight or obesity
Read the detailed description
In this Phase 3 study, eligible participants will be randomized into three cohorts in a 3:1:3:1:3:1 ratio to receive once-weekly subcutaneous XW003 (low, medium, or high dosage) or volume-matching placebo for 48 weeks, including a dose-escalation period.
- Conditions
- Weight Management
- Being tested
- Ecnoglutide Low Dosage, Ecnoglutide Medium Dosage, Ecnoglutide High Dosage, Placebo
- Keywords
- Weight management, overweight, obesity, glucagon-like peptide-1 (GLP-1), ecnoglutide, XW003
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ecnoglutide Low DosageDrug
Also called XW003
Subcutaneous Injection
Ecnoglutide Medium DosageDrug
Also called XW003
Subcutaneous Injection
Ecnoglutide High DosageDrug
Also called XW003
Subcutaneous Injection
PlaceboDrug
Subcutaneous Injection with matched volume
| Study group | Role | What they receive |
|---|---|---|
| C1- XW003 Low Dosage | Experimental | XW003 with low dosage once weekly Receives: Drug: Ecnoglutide Low Dosage |
| C1-Placebo | Placebo comparator | Matched Placebo once weekly Receives: Drug: Placebo |
| C2- XW003 Medium Dosage | Experimental | XW003 with medium dosage once weekly Receives: Drug: Ecnoglutide Medium Dosage |
| C2-Placebo | Placebo comparator | Matched Placebo once weekly Receives: Drug: Placebo |
| C3- XW003 High Dosage | Experimental | XW003 with high dosage once weekly Receives: Drug: Ecnoglutide High Dosage |
| C3-Placebo | Placebo comparator | Matched Placebo once weekly Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change in body weight from baseline
Measured: Week 40
Proportion of subjects with weight loss ≥5% from baseline
Measured: Week 40
Secondary outcomes (4)
Percent and absolute body weight change from baseline
Measured: Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40 and Week 48
Proportion of subjects with weight loss ≥ 5%, 10%, 15% from baseline
Measured: Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40 and Week 48
Change from baseline in BMI
height will be only measured at baseline
Measured: Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40 and Week 48
Change from baseline in waist and hip circumferences
Measured: Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40 and Week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2023
- Study start5 Apr 2023
- Primary completion20 Jun 2024
- Study completion10 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Weight ManagementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 664 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hangzhou Sciwind Biosciences Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Linong Ji, Dr, Principal investigator, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05813795
- Sponsor's protocol ID
- SCW0502-1131
- Status last verified
- Jul 2024
- First submitted
- 20 Mar 2023
- Last updated
- 30 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ji L, Gao L, Xue H, Tian J, Wang K, Jiang H, Huang C, Lian Q, Yuan M, Gao G, Lu Y, Han J, Fu W, Wang H, Zhang Y, Shi X, Wen B, Shi B, Hu W, Guo T, Xing Y, Li Y, Li Q, Zheng Q, Yang M, Ning J, Guo M, Li Y, Pan H. Efficacy and safety of a biased GLP-1 receptor agonist ecnoglutide in adults with overweight or obesity: a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Diabetes Endocrinol. 2025 Sep;13(9):777-789. doi: 10.1016/S2213-8587(25)00141-X. Epub 2025 Jun 21.
PubMed 40555243
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Multi-center, Randomized, Double-Blind and Placebo-controlled Study to Evaluate the Efficacy and Safety of XW003 in Adults With Overweight or Obesity (SLIMMER)
- ClinicalTrials.gov ID
- NCT05813795
- Acronym / sponsor ID
- SCW0502-1131
- Conditions
- Weight Management
- Keywords
- Weight management, overweight, obesity, glucagon-like peptide-1 (GLP-1), ecnoglutide, XW003
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 664 participants (actual)
- Lead sponsor
- Hangzhou Sciwind Biosciences Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 5 Apr 2023 (actual)
- Primary completion
- 20 Jun 2024 (actual)
- Study completion
- 10 Oct 2024 (actual)
- First posted
- 14 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the study is to evaluate the efficacy and safety of XW003 versus placebo in adults with overweight or obesity
Detailed description
In this Phase 3 study, eligible participants will be randomized into three cohorts in a 3:1:3:1:3:1 ratio to receive once-weekly subcutaneous XW003 (low, medium, or high dosage) or volume-matching placebo for 48 weeks, including a dose-escalation period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| C1- XW003 Low Dosage | Experimental | Drug: Ecnoglutide Low DosageXW003 with low dosage once weekly |
| C1-Placebo | Placebo comparator | Drug: PlaceboMatched Placebo once weekly |
| C2- XW003 Medium Dosage | Experimental | Drug: Ecnoglutide Medium DosageXW003 with medium dosage once weekly |
| C2-Placebo | Placebo comparator | Drug: PlaceboMatched Placebo once weekly |
| C3- XW003 High Dosage | Experimental | Drug: Ecnoglutide High DosageXW003 with high dosage once weekly |
| C3-Placebo | Placebo comparator | Drug: PlaceboMatched Placebo once weekly |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female, 18-75 years old, inclusive;
- BMI between 24.0 to 28.0 kg/m2 with at least one comorbidity, including prediabetes, hypertension, hyperlipidemia, fatty liver , obstructive sleep apnea syndrome, etc.; or BMI ≥ 28 kg/m2 with or without comorbidities.
- Weight change of no more than 5% (based on self-report), with diet and exercise alone, within 3 months before screening.
- Willing and able to maintain stable diet and exercise during the study period.
Key exclusion criteria (7 listed)
- Obesity induced by endocrine diseases such as hypothyroidism, Cushing Syndrome, etc.
- History of bariatric surgery (except liposuction >1 year ago) or planned bariatric surgery during the study period.
- Within 3 months before screening, history of using the following drugs or treatments:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ecnoglutide Low DosageAlso: XW003Subcutaneous Injection | Drug | C1- XW003 Low Dosage |
| Ecnoglutide Medium DosageAlso: XW003Subcutaneous Injection | Drug | C2- XW003 Medium Dosage |
| Ecnoglutide High DosageAlso: XW003Subcutaneous Injection | Drug | C3- XW003 High Dosage |
| PlaceboSubcutaneous Injection with matched volume | Drug | C1-Placebo, C2-Placebo, C3-Placebo |
Primary outcome
Percent change in body weight from baseline
Time frame: Week 40
Proportion of subjects with weight loss ≥5% from baseline
Time frame: Week 40
4 secondary outcomes
Percent and absolute body weight change from baseline
Time frame: Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40 and Week 48
Proportion of subjects with weight loss ≥ 5%, 10%, 15% from baseline
Time frame: Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40 and Week 48
Change from baseline in BMI
Time frame: Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40 and Week 48
Change from baseline in waist and hip circumferences
Time frame: Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40 and Week 48
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2025.
- Derived from this study: PubMed 40555243Ji L, Gao L, Xue H, Tian J, Wang K, Jiang H, Huang C, Lian Q, Yuan M, Gao G, Lu Y, Han J, Fu W, Wang H, Zhang Y, Shi X, Wen B, Shi B, Hu W, Guo T, Xing Y, Li Y, Li Q, Zheng Q, Yang M, Ning J, Guo M, Li Y, Pan H. Efficacy and safety of a biased GLP-1 receptor agonist ecnoglutide in adults with overweight or obesity: a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Diabetes Endocrinol. 2025 Sep;13(9):777-789. doi: 10.1016/S2213-8587(25)00141-X. Epub 2025 Jun 21.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Linong Ji, Dr principal investigator
Peking University People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ecnoglutide Low Dosage, Ecnoglutide Medium Dosage and Ecnoglutide High Dosage in people with Weight Management, run by Hangzhou Sciwind Biosciences Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent change in body weight from baseline (time frame: Week 40). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05813795, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2025.