Overweight and/or ObesityPhase 1/2NCT07243171
A Phase Ib/IIa Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral Ecnoglutide Tablets in Chinese Participants With Overweight or Obesity
A Phase 1/2 study testing ecnoglutide tablets in people with Overweight and/or Obesity and 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 safety, tolerability, pharmacokinetics and pharmacodynamics of oral ecnoglutide tablets in Chinese participants with overweight or obesity Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight and/or Obesity, Weight Management
- What is being tested?
- ecnoglutide tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 126 participants
- Where
- 1 siteChina
- Study dates
- 18 Nov 2025to 28 Apr 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- At the time of informed consent, with BMI in the range of 24.0 to 35.0 kg/m2 (including the threshold), body weight >60.0 kg for male, and weight >50.0 kg for female;
- Self-declaration of body weight change <5% within 3 months prior to informed consent ;
Who cannot join
- Diagnosis of overweight or obesity due to endocrine disorders , such as Cushing's syndrome;
- Diagnosis of other endocrine disorders with clinical significance, including but not limited to hyperthyroidism or hypothyroidism, thyroid nodules (imaging shows TI-RADS≥ class 3), thyroid cancer, or personal or family history of type 2 multiple endocrine tumor syndrome (MEN2), etc.
- Diagnosis of cardiovascular or cerebrovascular diseases with clinical significance within 6 months prior to screening, including but not limited to acute stroke, acute coronary syndrome, heart failure, arrhythmia, etc.
- Diagnosis of severe gastrointestinal diseases, including but not limited to inflammatory bowel disease, active ulcers, irritable bowel syndrome, celiac disease, dyspepsia, diabetic gastroparesis, diabetic diarrhea, clinical gastric emptying abnormalities (such as pyloric obstruction), etc.
- History of major gastrointestinal surgery (except cholecystectomy or appendectomy), or metabolic surgery, or plan to undergo major surgery during the study period;
- HbA1c ≥6.5% or fasting blood glucose ≥7.0 mmol/L, or OGTT 2-hour blood glucose ≥11.1 mmol/L, at screening;
- Clinical laboratory test results with clinical significance
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
China-Japan Friendship Hospital
Beijing, Beijing Municipality, 100029
Li, 01084205566, ra@sciwindbio.com
About this study
Official title: A Multicenter, Multiple-dose Escalation, Randomized, Double-blind, Placebo-controlled Phase Ib/IIa Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral Ecnoglutide Tablets in Chinese Participants With Overweight or Obesity
The aim of the study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of oral ecnoglutide tablets in Chinese participants with overweight or obesity
Read the detailed description
In this study, eligible participants will be randomized to receive either oral ecnoglutide tablet or placebo once daily for up to 3 weeks (Cohort C1) or 4 weeks (Cohort C2 or C6), or once weekly for up to 24 weeks (Cohort C3, C4 and C5), including a dose escalation period.
- Conditions
- Overweight and/or Obesity, Weight Management
- Being tested
- ecnoglutide tablets, placebo with matching dosage
- Keywords
- ecnoglutide, glucagon-like peptide-1 (GLP-1), obesity, overweight, weight management
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ecnoglutide tabletsDrug
oral tablets
placebo with matching dosageDrug
oral tablets
| Study group | Role | What they receive |
|---|---|---|
| oral ecnoglutide dose 1 | Experimental | once daily Receives: Drug: ecnoglutide tablets |
| oral ecnoglutide dose 2 | Experimental | once daily Receives: Drug: ecnoglutide tablets |
| oral ecnoglutide dose 3 | Experimental | once weekly Receives: Drug: ecnoglutide tablets |
| oral ecnoglutide dose 4 | Experimental | once weekly Receives: Drug: ecnoglutide tablets |
| placebo dose 1 | Placebo comparator | once daily Receives: Drug: placebo with matching dosage |
| placebo dose 2 | Placebo comparator | once weekly Receives: Drug: placebo with matching dosage |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence and severity of adverse events
Measured: up to day 204
Secondary outcomes (10)
Pharmacokinetics of oral ecnoglutide tablet
Cmax, Tmax and AUC
Measured: up to day 204
Change of body weight from baseline
Measured: up to day 204
Change of BMI from baseline
Measured: up to day 204
Change of waist circumference from baseline
Measured: up to day 204
Change of hip circumference from baseline
Measured: up to day 204
Change of neck circumference from baseline
Measured: up to day 204
Change of waist/hip ratio from baseline
Measured: up to day 204
Change of fasting blood glucose from baseline
Measured: up to day 204
Change of fasting insulin from baseline
Measured: up to day 204
Change of lipid profile from baseline
Measured: up to day 204
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2025
- Study start18 Nov 2025
- Primary completion5 Jan 2027 (estimated)
- Study completion28 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and/or ObesityStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hangzhou Sciwind Biosciences Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jintong Li, Dr, Principal investigator, China-Japan Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07243171
- Sponsor's protocol ID
- SCW0503-1012
- Status last verified
- Oct 2025
- First submitted
- 17 Nov 2025
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Multiple-dose Escalation, Randomized, Double-blind, Placebo-controlled Phase Ib/IIa Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral Ecnoglutide Tablets in Chinese Participants With Overweight or Obesity
- ClinicalTrials.gov ID
- NCT07243171
- Acronym / sponsor ID
- SCW0503-1012
- Conditions
- Overweight and/or Obesity, Weight Management
- Keywords
- ecnoglutide, glucagon-like peptide-1 (GLP-1), obesity, overweight, weight management
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- Hangzhou Sciwind Biosciences Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 18 Nov 2025 (actual)
- Primary completion
- 5 Jan 2027 (estimated)
- Study completion
- 28 Apr 2027 (estimated)
- First posted
- 21 Nov 2025 (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 safety, tolerability, pharmacokinetics and pharmacodynamics of oral ecnoglutide tablets in Chinese participants with overweight or obesity
Detailed description
In this study, eligible participants will be randomized to receive either oral ecnoglutide tablet or placebo once daily for up to 3 weeks (Cohort C1) or 4 weeks (Cohort C2 or C6), or once weekly for up to 24 weeks (Cohort C3, C4 and C5), including a dose escalation period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| oral ecnoglutide dose 1 | Experimental | Drug: ecnoglutide tabletsonce daily |
| oral ecnoglutide dose 2 | Experimental | Drug: ecnoglutide tabletsonce daily |
| oral ecnoglutide dose 3 | Experimental | Drug: ecnoglutide tabletsonce weekly |
| oral ecnoglutide dose 4 | Experimental | Drug: ecnoglutide tabletsonce weekly |
| placebo dose 1 | Placebo comparator | Drug: placebo with matching dosageonce daily |
| placebo dose 2 | Placebo comparator | Drug: placebo with matching dosageonce weekly |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- At the time of informed consent, with BMI in the range of 24.0 to 35.0 kg/m2 (including the threshold), body weight >60.0 kg for male, and weight >50.0 kg for female;
- Self-declaration of body weight change <5% within 3 months prior to informed consent ;
Key exclusion criteria (7 listed)
- Diagnosis of overweight or obesity due to endocrine disorders , such as Cushing's syndrome;
- Diagnosis of other endocrine disorders with clinical significance, including but not limited to hyperthyroidism or hypothyroidism, thyroid nodules (imaging shows TI-RADS≥ class 3), thyroid cancer, or personal or family history of type 2 multiple endocrine tumor syndrome (MEN2), etc.
- Diagnosis of cardiovascular or cerebrovascular diseases with clinical significance within 6 months prior to screening, including but not limited to acute stroke, acute coronary syndrome, heart failure, arrhythmia, etc.
- Diagnosis of severe gastrointestinal diseases, including but not limited to inflammatory bowel disease, active ulcers, irritable bowel syndrome, celiac disease, dyspepsia, diabetic gastroparesis, diabetic diarrhea, clinical gastric emptying abnormalities (such as pyloric obstruction), etc.
- History of major gastrointestinal surgery (except cholecystectomy or appendectomy), or metabolic surgery, or plan to undergo major surgery during the study period;
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 tabletsoral tablets | Drug | oral ecnoglutide dose 1, oral ecnoglutide dose 2, oral ecnoglutide dose 3, oral ecnoglutide dose 4 |
| placebo with matching dosageoral tablets | Drug | placebo dose 1, placebo dose 2 |
Primary outcome
The incidence and severity of adverse events
Time frame: up to day 204
10 secondary outcomes
Pharmacokinetics of oral ecnoglutide tablet
Time frame: up to day 204
Change of body weight from baseline
Time frame: up to day 204
Change of BMI from baseline
Time frame: up to day 204
Change of waist circumference from baseline
Time frame: up to day 204
Change of hip circumference from baseline
Time frame: up to day 204
Change of neck circumference from baseline
Time frame: up to day 204
Change of waist/hip ratio from baseline
Time frame: up to day 204
Change of fasting blood glucose from baseline
Time frame: up to day 204
Change of fasting insulin from baseline
Time frame: up to day 204
Change of lipid profile from baseline
Time frame: up to day 204
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- 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.
Jintong Li, Dr principal investigator
China-Japan Friendship Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ecnoglutide tablets in people with Overweight and/or Obesity and 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 2 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: looking for participants now, as of the sponsor's last update on 16 Sep 2026. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence and severity of adverse events (time frame: up to day 204). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Sep 2026.