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RecruitingNCT07243171Updated Sep 16, 2026

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 interventional study of ecnoglutide tablets and placebo with matching dosage in Overweight and/or Obesity and Weight Management, sponsored by Hangzhou Sciwind Biosciences Co., Ltd.. Recruiting at 1 site in China. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-16.

Sponsored by Hangzhou Sciwind Biosciences Co., Ltd. · Phase 1/2, Interventional, and Treatment

From the registry’s dates

  • Started Nov 2025; still recruiting 10 months later.
Phase
Phase 1/2
Study type
Interventional
Enrollment
126
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Overweight and/or Obesity
  • Weight Management

Keywords

  • ecnoglutide
  • glucagon-like peptide-1 (GLP-1)
  • obesity
  • overweight
  • weight management
03

In context

Obesity

6,296 studies on the registry are indexed under Obesity; 1,695 are open to participants now.

This study's planned enrollment of 126 is above the median of 78 across 4,878 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

Hangzhou Sciwind Biosciences Co., Ltd. is the lead sponsor of 13 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. 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;
  2. Self-declaration of body weight change \<5% within 3 months prior to informed consent ;

Exclusion criteria

Exclusion Criteria:

  1. Diagnosis of overweight or obesity due to endocrine disorders , such as Cushing's syndrome;
  2. 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.
  3. 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.
  4. 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.
  5. History of major gastrointestinal surgery (except cholecystectomy or appendectomy), or metabolic surgery, or plan to undergo major surgery during the study period;
  6. HbA1c ≥6.5% or fasting blood glucose ≥7.0 mmol/L, or OGTT 2-hour blood glucose ≥11.1 mmol/L, at screening;
  7. Clinical laboratory test results with clinical significance
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
126 participants (estimated)

Study arms

  • Experimental
    oral ecnoglutide dose 1

    once daily

    Drug: ecnoglutide tablets

  • Experimental
    oral ecnoglutide dose 2

    once daily

    Drug: ecnoglutide tablets

  • Experimental
    oral ecnoglutide dose 3

    once weekly

    Drug: ecnoglutide tablets

  • Experimental
    oral ecnoglutide dose 4

    once weekly

    Drug: ecnoglutide tablets

  • Placebo comparator
    placebo dose 1

    once daily

    Drug: placebo with matching dosage

  • Placebo comparator
    placebo dose 2

    once weekly

    Drug: placebo with matching dosage

Interventions

  • Drugecnoglutide tablets

    oral tablets

  • Drugplacebo with matching dosage

    oral tablets

06

What researchers measure

Primary outcomes

  1. The incidence and severity of adverse events

    Time frame: up to day 204

Secondary outcomes

  1. Pharmacokinetics of oral ecnoglutide tablet

    Cmax, Tmax and AUC

    Time frame: up to day 204

  2. Change of body weight from baseline

    Time frame: up to day 204

  3. Change of BMI from baseline

    Time frame: up to day 204

  4. Change of waist circumference from baseline

    Time frame: up to day 204

  5. Change of hip circumference from baseline

    Time frame: up to day 204

  6. Change of neck circumference from baseline

    Time frame: up to day 204

  7. Change of waist/hip ratio from baseline

    Time frame: up to day 204

  8. Change of fasting blood glucose from baseline

    Time frame: up to day 204

  9. Change of fasting insulin from baseline

    Time frame: up to day 204

  10. Change of lipid profile from baseline

    Time frame: up to day 204

Other outcomes

  1. Immunogenecity of oral ecnoglutide tablet

    Time frame: up to day 204

07

Study locations

1 of 1 sites recruiting
  • China-Japan Friendship Hospital
    Beijing, Beijing Municipality 100029, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07243171
Lead sponsor
Hangzhou Sciwind Biosciences Co., Ltd.
Responsible party
Sponsor
First posted
Nov 21, 2025
Start date
Nov 18, 2025
Primary completion
Jan 5, 2027 (estimated)
Completion
Apr 28, 2027 (estimated)
Last update
Sep 16, 2026

Study contacts

Jintong Li, Dr
principal investigator · China-Japan Friendship Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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