A Study to Evaluate the Safety and Efficacy of Ecnoglutide Tablets in Chinese Participants With Overweight or Obesity

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Study to Evaluate the Safety and Efficacy of Oral Ecnoglutide Tablets in Chinese Participants With Overweight or Obesity

The aim of the study is to evaluate the safety and efficacy of oral ecnoglutide tablets in Chinese participants with overweight or obesity

Study Overview

• Status: Not yet recruiting
• Conditions: Weight Management; Overweight , Obesity
• Intervention / Treatment: Drug: ecnoglutide tablet; Drug: placebo with matching dosage

Detailed Description

In this study, eligible participants will be randomized to one of the four cohorts to receive either oral ecnoglutide tablet or placebo for up to 24 weeks, including a dose escalation period.

• Study Type: Interventional
• Enrollment (Estimated): 180
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Yao Li; Phone Number: 010-67889253; Email: ra@sciwindbio.com

Study Locations

• China
  • Henan
    • Luoyang, Henan, China
      • The First Affiliated Hospital of Henan University of Science & Technology
      • Contact: Hongwei Jiang; Phone Number: 010-67889253; Email: ra@sciwindbio.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. At the time of informed consent, BMI≥28.0 kg/m^2 regardless of comorbidities, or 24.0kg/m^2≤BMI<28.0 kg/m^2 with at least one of the comorbidities (prediabetes, hypertension, dyslipidemia, fatty liver, obstructive sleep apnea syndrome, weight-bearing joint pain, etc.);
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 C-TIRADS≥ class 4A), Medullary thyroid carcinoma, 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 myocardial infarction, coronary angioplasty or bypass surgery, valvular heart disease or valve repair, unstable angina, transient ischemic attack, acute stroke, acute coronary syndrome, congestive heart failure classified as New York Heart Association class III or IV, clinically significant arrhythmias requiring treatment, and cerebrovascular accidents, etc.
4. Diagnosis of gastrointestinal diseases with clinical significance within 6 months prior to screening, including but not limited to inflammatory bowel disease, active ulcers, irritable bowel syndrome, celiac disease, dyspepsia, 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

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: oral ecnoglutide dose 1; once daily from week1 to week 8, then once weekly from week 9 to week 24	Drug: ecnoglutide tablet; oral tablet
Experimental: oral ecnoglutide dose 2; once daily from week1 to week 8, then once weekly from week 9 to week 24	Drug: ecnoglutide tablet; oral tablet
Experimental: oral ecnoglutide dose 3; once daily from week1 to week 12, then once weekly from week 13 to week 24	Drug: ecnoglutide tablet; oral tablet
Placebo Comparator: Placebo; once daily from week1 to week 8 or week 12, then once weekly from week 9 or week 13 to week 24	Drug: placebo with matching dosage; oral tablet
Experimental: oral ecnoglutide dose 4; once daily from week1 to week 12, then once weekly from week 13 to week 24	Drug: ecnoglutide tablet; oral tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage Change in Body Weight	Baseline, week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants with ≥5% of Body Weight Loss		Baseline, week 24
Percentage of Participants with ≥10% of Body Weight Loss		Baseline, week 24
Percentage of Participants with ≥15% of Body Weight Loss		Baseline, week 24
Absolute Change in Body Weight		Baseline, week 24
Change in Body Mass Index (BMI)		Baseline, week 24
Change in blood pressure		Baseline, week 24
Change in other body measurements	Body measurements include neck circumference, waist circumference, hip circumference	Baseline, week 24
Change in lipid profile	Include triglicerides, LDL-C, HDL-C, total cholesterol	Baseline, week 24
Change in fasting blood glucose (FBG)		Baseline, week 24
Change in HbA1c		Baseline, week 24
Change in fasting insulin		Baseline, week 24
Change in blood uric acid		Baseline, week 24
Change in liver enzymes	include ALT and AST	Baseline, week 24
Adverse events		Week 1 to week 28 (EOS)
Plasma Concentration of Ecnoglutide		Week 1 to week 28 (EOS)

Collaborators and Investigators

• Sponsor: Hangzhou Sciwind Biosciences Co., Ltd.
• Investigators: Principal Investigator: Hongwei Jiang, The First Affiliated Hospital of Henan University of Science and Technology

Study record dates

Study Major Dates

• Study Start (Estimated): November 10, 2026
• Primary Completion (Estimated): September 3, 2027
• Study Completion (Estimated): January 28, 2028

Study Registration Dates

• First Submitted: October 28, 2026
• First Submitted That Met QC Criteria: November 4, 2026
• First Posted (Actual): November 10, 2026

Study Record Updates

• Last Update Posted (Actual): November 10, 2026
• Last Update Submitted That Met QC Criteria: November 4, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: Obesity; 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: SCW0503-1121

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