T2DMPhase 3NCT05680155
A Phase 3 Study to Evaluate the Efficacy of XW003 Compared With Placebo in T2DM Patients
A Phase 3 study testing Ecnoglutide in people with T2DM and Type 2 Diabetes Mellitus, run by Hangzhou Sciwind Biosciences Co., Ltd. at 1 site in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- T2DM, Type 2 Diabetes Mellitus
- What is being tested?
- Ecnoglutide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 211 participants
- Where
- 1 siteChina
- Study dates
- 29 Dec 2022to 12 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
- Ability and willingness to participate in the study, give written informed consent, and comply with the study specific requirements and all protocol procedures.
- Sex: male or female; Age: 18 to 75 years, inclusive
- BMI: 20.0 kg/m^2 to 35.0 kg/m^2, inclusive
- Have been diagnosed with T2DMthat is inadequately controlled with at least 3 months of diet and exercise prior to screening.
- HbA1c ranging from 7.5% to 11.0% at screening, inclusive
- FPG ≤13.9 mmol/L at screening.
Who cannot join
- History of type 1 or other types of diabetes mellitus.
- Use of any GLP-1 analogue during the 3 months preceding to screening.
- History of proliferative diabetic retinopathy, diabetic maculopathy, diabetic neuropathy, or diabetic foot during the 6 months preceding screening.
- History of acute or chronic pancreatitis or high risk factors for pancreatitis.
- Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2.
- History of stomach surgeries or disorders associated with slowed emptying of the stomach during the past 6 months.
- History of heart attack, stroke, or congestive heart failure of Grade 3 or 4 in the past 6 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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
Read the 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.
- Conditions
- T2DM, Type 2 Diabetes Mellitus
- Being tested
- Ecnoglutide, Placebo
- Keywords
- T2DM, Glucagon-like peptide-1, Ecnoglutide, XW003, GLP-1
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EcnoglutideDrug
Also called XW003
Subcutaneous Injection
PlaceboDrug
Subcutaneous Injection with matched volume
| Study group | Role | What they receive |
|---|---|---|
| C1-XW003 | Experimental | High dosage of XW003 once weekly Receives: Drug: Ecnoglutide |
| C1-Placebo | Placebo comparator | Matched Placebo once weekly Receives: Drug: Placebo |
| C2-XW003 | Experimental | Low dosage of XW003 once weekly Receives: Drug: Ecnoglutide |
| C2-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.
Change from baseline in HbA1c
Measured: Baseline, Week 24
Secondary outcomes (13)
Change from baseline in HbA1c
Measured: Baseline, Week 5, Week 9, Week 13, Week 17, Week 29, Week 33, Week 37, Week 45, Week 52
Proportion of subjects with HbA1c < 7% and HbA1c ≤6.5% after treatment
Measured: week 24, week 52
Proportion of subjects with HbA1c < 7%, with no severe hypoglycemia or no weight gain
Measured: week 24
Change from baseline in fasting plasma glucose (FPG)
Measured: Baseline, Week 24 and Week 52
Change from baseline in fasting insulin
Measured: Baseline, Week 24 and Week 52
Change from baseline in lipid panel
Measured: Baseline, Week 24 and Week 52
Change from baseline in 2-hour postprandial blood glucose
Measured: Baseline, Week 24 and Week 52
Change from baseline in 7-point self-monitored blood glucose
Measured: Baseline, Week 24 and Week 52
Change from baseline in HOMA-IR
Measured: Baseline, Week 24 and Week 52
Change from baseline in HOMA-β
Measured: Baseline, Week 24 and Week 52
Change from baseline in body weight
Measured: Baseline, Week 24 and Week 52
Change from baseline in waist circumference
Measured: Baseline, Week 24 and Week 52
Change from baseline in hip circumference
Measured: Baseline, Week 24 and Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2023
- Study start29 Dec 2022
- Primary completion12 Jun 2024
- Study completion12 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 T2DMStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 211 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hangzhou Sciwind Biosciences Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dalong Zhu, Principal investigator, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05680155
- Sponsor's protocol ID
- SCW0502-1031
- Status last verified
- Jul 2023
- First submitted
- 25 Dec 2022
- Last updated
- 10 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhu D, Wang W, Tong G, Ma J, Wen B, Zheng X, Shi B, Pang S, Wang K, Shi X, Zhang X, Fu L, Liu Y, Lu Y, Huang D, Jiang C, Pan T, Xue H, Han J, Ding H, Bing S, Jiang F, Zheng Q, Yang M, Guan L, Liu X, Ning J, Bu Y, Guo M, Yang L, Guo W, Li Y, Xu S, Pan H. Efficacy and safety of cAMP signalling-biased GLP-1 analogue ecnoglutide monotherapy versus placebo in patients with type 2 diabetes (EECOH-1): a multi-centre, randomised, double-blind, placebo-controlled, phase 3 trial. Nat Commun. 2026 Jan 7;17(1):1420. doi: 10.1038/s41467-025-68165-7.
PubMed 41501026
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05680155
- Acronym / sponsor ID
- SCW0502-1031
- Conditions
- T2DM, Type 2 Diabetes Mellitus
- Keywords
- T2DM, Glucagon-like peptide-1, Ecnoglutide, XW003, GLP-1
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 211 participants (actual)
- Lead sponsor
- Hangzhou Sciwind Biosciences Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 29 Dec 2022 (actual)
- Primary completion
- 12 Jun 2024 (actual)
- Study completion
- 12 Oct 2024 (actual)
- First posted
- 11 Jan 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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| C1-XW003 | Experimental | Drug: EcnoglutideHigh dosage of XW003 once weekly |
| C1-Placebo | Placebo comparator | Drug: PlaceboMatched Placebo once weekly |
| C2-XW003 | Experimental | Drug: EcnoglutideLow dosage of XW003 once weekly |
| C2-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 (6 listed)
- Ability and willingness to participate in the study, give written informed consent, and comply with the study specific requirements and all protocol procedures.
- Sex: male or female; Age: 18 to 75 years, inclusive
- BMI: 20.0 kg/m^2 to 35.0 kg/m^2, inclusive
- Have been diagnosed with T2DMthat is inadequately controlled with at least 3 months of diet and exercise prior to screening.
- HbA1c ranging from 7.5% to 11.0% at screening, inclusive
Key exclusion criteria (7 listed)
- History of type 1 or other types of diabetes mellitus.
- Use of any GLP-1 analogue during the 3 months preceding to screening.
- History of proliferative diabetic retinopathy, diabetic maculopathy, diabetic neuropathy, or diabetic foot during the 6 months preceding screening.
- History of acute or chronic pancreatitis or high risk factors for pancreatitis.
- Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2.
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 |
|---|---|---|
| EcnoglutideAlso: XW003Subcutaneous Injection | Drug | C1-XW003, C2-XW003 |
| PlaceboSubcutaneous Injection with matched volume | Drug | C1-Placebo, C2-Placebo |
Primary outcome
Change from baseline in HbA1c
Time frame: Baseline, Week 24
13 secondary outcomes
Change from baseline in HbA1c
Time frame: Baseline, Week 5, Week 9, Week 13, Week 17, Week 29, Week 33, Week 37, Week 45, Week 52
Proportion of subjects with HbA1c < 7% and HbA1c ≤6.5% after treatment
Time frame: week 24, week 52
Proportion of subjects with HbA1c < 7%, with no severe hypoglycemia or no weight gain
Time frame: week 24
Change from baseline in fasting plasma glucose (FPG)
Time frame: Baseline, Week 24 and Week 52
Change from baseline in fasting insulin
Time frame: Baseline, Week 24 and Week 52
Change from baseline in lipid panel
Time frame: Baseline, Week 24 and Week 52
Change from baseline in 2-hour postprandial blood glucose
Time frame: Baseline, Week 24 and Week 52
Change from baseline in 7-point self-monitored blood glucose
Time frame: Baseline, Week 24 and Week 52
Change from baseline in HOMA-IR
Time frame: Baseline, Week 24 and Week 52
Change from baseline in HOMA-β
Time frame: Baseline, Week 24 and Week 52
Change from baseline in body weight
Time frame: Baseline, Week 24 and Week 52
Change from baseline in waist circumference
Time frame: Baseline, Week 24 and Week 52
Change from baseline in hip circumference
Time frame: Baseline, Week 24 and Week 52
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 10 Sep 2025.
- Derived from this study: PubMed 41501026Zhu D, Wang W, Tong G, Ma J, Wen B, Zheng X, Shi B, Pang S, Wang K, Shi X, Zhang X, Fu L, Liu Y, Lu Y, Huang D, Jiang C, Pan T, Xue H, Han J, Ding H, Bing S, Jiang F, Zheng Q, Yang M, Guan L, Liu X, Ning J, Bu Y, Guo M, Yang L, Guo W, Li Y, Xu S, Pan H. Efficacy and safety of cAMP signalling-biased GLP-1 analogue ecnoglutide monotherapy versus placebo in patients with type 2 diabetes (EECOH-1): a multi-centre, randomised, double-blind, placebo-controlled, phase 3 trial. Nat Commun. 2026 Jan 7;17(1):1420. doi: 10.1038/s41467-025-68165-7.
- 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.
Dalong Zhu principal investigator
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
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 in people with T2DM and Type 2 Diabetes Mellitus, 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 6 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 10 Sep 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?
Change from baseline in HbA1c (time frame: Baseline, Week 24). 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 NCT05680155, 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 10 Sep 2025.