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 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

Study Overview

• Status: Recruiting
• Conditions: Overweight and/or Obesity; Weight Management
• Intervention / Treatment: Drug: ecnoglutide tablets; Drug: placebo with matching dosage

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 once weekly for up to 24 weeks (Cohort C3 and C4), including a dose escalation period.

• Study Type: Interventional
• Enrollment (Estimated): 84
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Jing Ning; Phone Number: (86) 010-67889253; Email: jing.ning@sciwindbio.com

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100029
      • Recruiting
      • China-Japan Friendship Hospital
      • Contact: Li; Phone Number: 01084205566

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: oral ecnoglutide dose 1; once daily	Drug: ecnoglutide tablets; oral tablets
Experimental: oral ecnoglutide dose 2; once daily	Drug: ecnoglutide tablets; oral tablets
Experimental: oral ecnoglutide dose 3; once weekly	Drug: ecnoglutide tablets; oral tablets
Experimental: oral ecnoglutide dose 4; once weekly	Drug: ecnoglutide tablets; oral tablets
Placebo Comparator: placebo dose 1; once daily	Drug: placebo with matching dosage; oral tablets
Placebo Comparator: placebo dose 2; once weekly	Drug: placebo with matching dosage; oral tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The incidence and severity of adverse events	up to day 204

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetics of oral ecnoglutide tablet	Cmax, Tmax and AUC	up to day 204
Change of body weight from baseline		up to day 204
Change of BMI from baseline		up to day 204
Change of waist circumference from baseline		up to day 204
Change of hip circumference from baseline		up to day 204
Change of neck circumference from baseline		up to day 204
Change of waist/hip ratio from baseline		up to day 204
Change of fasting blood glucose from baseline		up to day 204
Change of fasting insulin from baseline		up to day 204
Change of lipid profile from baseline		up to day 204

Other Outcome Measures

Outcome Measure	Time Frame
Immunogenecity of oral ecnoglutide tablet	up to day 204

Collaborators and Investigators

• Sponsor: Hangzhou Sciwind Biosciences Co., Ltd.
• Investigators: Principal Investigator: Jintong Li, Dr, China-Japan Friendship Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 18, 2025
• Primary Completion (Estimated): August 3, 2026
• Study Completion (Estimated): November 22, 2026

Study Registration Dates

• First Submitted: November 17, 2025
• First Submitted That Met QC Criteria: November 17, 2025
• First Posted (Actual): November 21, 2025

Study Record Updates

• Last Update Posted (Actual): January 28, 2026
• Last Update Submitted That Met QC Criteria: January 27, 2026
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: obesity; overweight; weight management; glucagon-like peptide-1 (GLP-1); ecnoglutide
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Overweight; Obesity
• Other Study ID Numbers: SCW0503-1012

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No