A Phase Ib/IIa Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral Ecnoglutide Tablets in Chinese Participants With Overweight or Obesity

NCT07243171 | Recruiting Phase 1

• 1 other identifier: SCW0503-1012
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Overweight and/or Obesity; Weight Management

Keywords

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

Outcome Measures

Primary Outcomes (1)

• The incidence and severity of adverse events

  up to day 204

Secondary Outcomes (10)

• Pharmacokinetics of oral ecnoglutide tablet

  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

Other Outcomes (1)

• Immunogenecity of oral ecnoglutide tablet

  up to day 204

Study Arms (6)

oral ecnoglutide dose 1

EXPERIMENTAL

once daily

Drug: ecnoglutide tablets

oral ecnoglutide dose 2

EXPERIMENTAL

once daily

Drug: ecnoglutide tablets

oral ecnoglutide dose 3

EXPERIMENTAL

once weekly

Drug: ecnoglutide tablets

oral ecnoglutide dose 4

EXPERIMENTAL

once weekly

Drug: ecnoglutide tablets

placebo dose 1

PLACEBO COMPARATOR

once daily

Drug: placebo with matching dosage

placebo dose 2

PLACEBO COMPARATOR

once weekly

Drug: placebo with matching dosage

Interventions

ecnoglutide tablets DRUG

oral tablets

oral ecnoglutide dose 1; oral ecnoglutide dose 2; oral ecnoglutide dose 3; oral ecnoglutide dose 4

placebo with matching dosage DRUG

oral tablets

placebo dose 1; placebo dose 2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 ;

You may not qualify if:

• 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

Sponsors & Collaborators

• Hangzhou Sciwind Biosciences Co., Ltd.: lead

Study Sites (1)

China-Japan Friendship Hospital

Beijing, Beijing Municipality, 100029, China

RECRUITING

MeSH Terms

Conditions

Obesity; Overweight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jintong Li, Dr

  China-Japan Friendship Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: November 21, 2025
• Study Start: November 18, 2025
• Primary Completion (Estimated): January 5, 2027
• Study Completion (Estimated): April 28, 2027
• Last Updated: September 16, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)