A Phase I Study to Evaluate the Food Effect on Ecnoglutide Tablet

A Randomized, Open-label, Multiple-dose, Multicenter Phase I Study to Evaluate the Food Effect on the Pharmacokinetics of Ecnoglutide Tablets in Chinese Adult Participants

The aim of the study is to evaluate food effect on pharmacokinetics of oral ecnoglutide tablets in Chinese participants

Study Overview

• Status: Not yet recruiting
• Conditions: Weight Management; Food Effect in Healthy Volunteers
• Intervention / Treatment: Drug: Dose 1; Drug: Dose 2

Detailed Description

There are two parts in this study. Part I will assess the effect of high-fat meal, while eligible participants will be randomized and allocated to either cohort F1(fasting) or F2(with meal) in a ratio of 1:1 to receive oral ecnoglutide tablet for up to 14 days. Part II will assess the effect of different dosing conditions, while eligible participants will be randomized and allocated to either cohort T1(no intake after 30min of dosing) or T2(no intake after 60min of dosing) in a ratio of 1:1 to receive oral ecnoglutide tablet for up to 14 days.

• Study Type: Interventional
• Enrollment (Estimated): 72
• Phase: Phase 1

Contacts and Locations

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

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • Zhejiang Provincial People's Hospital
      • Contact: Yiwen Zhang; Phone Number: 0571-85893643; Email: ra@sciwindbio.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Body mass index (BMI): 19.0 kg/m² ≤ BMI < 30.0 kg/m², with body weight ≥ 55 kg (male) or ≥ 50 kg (female);
2. Participants of childbearing potential agree to have no plans for pregnancy during the entire study period and within 6 months after the last dose: female participants must be non-pregnant and non-lactating, with no plans to donate ova, and male participants must have no plans to donate sperm; all participants voluntarily use effective contraception, with female participants avoiding pregnancy and male participants avoiding causing pregnancy in their partners;

Exclusion Criteria:

1. History of severe drug allergy (especially known or suspected allergy to any component of Ecnoglutide Tablets, regardless of the severity of previous allergic reactions), or severe atopic allergic disease/history (e.g., asthma, urticaria, eczematous dermatitis, etc.), or discretion by the investigator to have a severe allergic condition (e.g., allergy to two or more drugs/foods, or repeated allergic reactions requiring medical intervention);
2. Diagnosis of overweight or obesity of endocrine origin, such as Cushing's syndrome;
3. Diagnosis of diabetes mellitus of any type (excluding gestational diabetes mellitus);
4. History of acute or chronic pancreatitis, pancreatic injury, symptomatic biliary disease, or other high-risk factors that may lead to pancreatitis;
5. Diagnosis of other endocrine diseases of significant clinical significance, including but not limited to hyperthyroidism or hypothyroidism, thyroid nodules (imaging showing C-TIRADS ≥ 4A), thyroid cancer, or a personal or family history of multiple endocrine neoplasia type 2 (MEN2);
6. Occurrence of severe gastrointestinal diseases, including but not limited to inflammatory bowel disease, active ulcers, severe irritable bowel syndrome, celiac disease, recurrent dyspepsia, or clinically abnormal gastric emptying (e.g., pyloric obstruction), within 6 months prior to screening; or presence of gastrointestinal symptoms such as nausea, vomiting, diarrhea, or constipation at screening/before the first dose;
7. Occurrence of severe hypoglycemia or recurrent symptomatic hypoglycemia (≥ 2 episodes within 6 months) (e.g., anxiety, dizziness, sweating, tremor, hunger, and poor concentration, etc.), within 6 months prior to screening;
8. Diagnosis of malignant tumor within 5 years, except for cured basal cell carcinoma of the skin, cervical carcinoma in situ, etc., as discreted by the investigator to be clinically insignificant;
9. History of depression, or other severe psychiatric illness, or suicidal ideation or suicidal behavior;
10. Within 3 months prior to screening, participation in and use of any investigational drug, vaccine, special medical food, or invasive device clinical trial, or planned participation in other clinical trials during the study period;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: F1; Day 1 to Day 14: Fast overnight for at least 10 hours before each dose, and take the tablet with 240 mL of plain water. No food intake is allowed within 4h after dose administration.	Drug: Dose 1; oral, once daily for 7 days; Drug: Dose 2; oral, once daily for 7 days
Experimental: F2; Day 1 to Day 13: take breakfast within 30min before each dose, and then take the tablet with 240 mL of plain water. No food intake is allowed within 4h after dose administration. Day 14: take breakfast with high fat and high calorie	Drug: Dose 1; oral, once daily for 7 days; Drug: Dose 2; oral, once daily for 7 days
Experimental: T1; Day 1 to Day 14: fast after 30min of dosing	Drug: Dose 1; oral, once daily for 7 days; Drug: Dose 2; oral, once daily for 7 days
Experimental: T2; Day 1 to Day 14: fast after 60min of dosing	Drug: Dose 1; oral, once daily for 7 days; Drug: Dose 2; oral, once daily for 7 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum concentration	Cmax of ecnoglutide	From Day1 to Day42
Minimum concentration	Cmin of ecnoglutide	From Day1 to Day42
Area under the curve from time 0 to infinity	AUC0-∞of ecnoglutide	From Day1 to Day42
Area under the curve from time 0 to 24h	AUC0-24h of ecnoglutide	From Day1 to Day42
Area under the curve from time 0 to last quantifiable time point	AUC0-t of ecnoglutide	From Day1 to Day42
Time to reach maximum concentration	Tmax of ecnoglutide	From Day1 to Day42

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence of adverse events		From Day1 to Day42
Anti-drug antibody	ADA of ecnoglutide	From Day1 to Day42

Collaborators and Investigators

• Sponsor: Hangzhou Sciwind Biosciences Co., Ltd.
• Investigators: Principal Investigator: Yiwen Zhang, Zhejiang Provincial People's Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): November 3, 2026
• Primary Completion (Estimated): April 15, 2027
• Study Completion (Estimated): April 15, 2027

Study Registration Dates

• First Submitted: November 4, 2026
• First Submitted That Met QC Criteria: November 11, 2026
• First Posted (Actual): November 13, 2026

Study Record Updates

• Last Update Posted (Actual): November 13, 2026
• Last Update Submitted That Met QC Criteria: November 11, 2026
• Last Verified: October 1, 2026

More Information

Terms related to this study

• Keywords: obesity; food effect; weight management; glucagon-like peptide-1 (GLP-1); ecnoglutide
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Obesity
• Other Study ID Numbers: SCW0503-1013

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