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

November 11, 2026 updated by: Hangzhou Sciwind Biosciences Co., Ltd.

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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
72

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • Zhejiang Provincial People's Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Maximum concentration
Time Frame: From Day1 to Day42

Cmax of ecnoglutide
From Day1 to Day42
Minimum concentration
Time Frame: From Day1 to Day42

Cmin of ecnoglutide
From Day1 to Day42
Area under the curve from time 0 to infinity
Time Frame: From Day1 to Day42

AUC0-∞of ecnoglutide
From Day1 to Day42
Area under the curve from time 0 to 24h
Time Frame: From Day1 to Day42

AUC0-24h of ecnoglutide
From Day1 to Day42
Area under the curve from time 0 to last quantifiable time point
Time Frame: From Day1 to Day42

AUC0-t of ecnoglutide
From Day1 to Day42
Time to reach maximum concentration
Time Frame: From Day1 to Day42

Tmax of ecnoglutide
From Day1 to Day42

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The incidence of adverse events
Time Frame: From Day1 to Day42
From Day1 to Day42
Anti-drug antibody
Time Frame: From Day1 to Day42

ADA of ecnoglutide
From Day1 to Day42

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hangzhou Sciwind Biosciences Co., Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Yiwen Zhang, Zhejiang Provincial People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 3, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 15, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 15, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 4, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 11, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 13, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 11, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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