Study of IPG1094 Tablets in Chinese Healthy Adults and Obese Adults

November 9, 2026 updated by: Nanjing Immunophage Biotech Co., Ltd

A Phase Ⅰ Clinical Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Preliminary Weight-Loss Effect of IPG1094 Tablets in Chinese Healthy Adults and Obese Adult Participants

This is a Phase I clinical study to evaluate the safety, tolerability, pharmacokinetics and preliminary weight-loss effect of IPG1094 tablets. The study includes three parts: Part A is single ascending dose in healthy volunteers; Part B is multiple ascending dose in healthy volunteers; Part C is multiple-dose exploration in obese adult participants. Subjects will be randomly assigned to receive IPG1094 or matching placebo. Safety, blood drug concentration and weight-related indicators will be followed up.

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.

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, 310013
        • Zhejiang 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. Male and female Chinese participants aged 18-50 years inclusive.
  2. Part A/B (healthy adults): Physical examination, vital signs, 12-lead ECG, chest X-ray, laboratory tests are normal or abnormalities considered not clinically significant by investigator; male body weight ≥50.0 kg, female ≥45.0 kg; BMI 19.0-26.0 kg/m².
  3. Part C (obese adults): BMI 28.0-35.0 kg/m²; body weight stable within 3 months prior to screening (weight change ≤5%). No concomitant diseases interfering with safety, PK or weight evaluation.
  4. Female participants are non-pregnant and non-lactating.
  5. All participants (male and female) agree to use effective contraception from informed consent through 6 months after last study drug administration; no plan for pregnancy, sperm / oocyte donation.
  6. For Part C: Able to complete hospitalization for first 10 days, outpatient visits, home drug administration and study diary; refrain from additional weight-loss medications, bariatric surgery or intensive weight-loss programs.
  7. Voluntarily sign written informed consent form.

Exclusion Criteria:

  1. History of severe/uncontrolled cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immune, dermatological, neurological or psychiatric diseases with ongoing clinical significance.
  2. ECG: QTcF >450 ms (male) / >470 ms (female).
  3. Recurrent headache/migraine, recurrent nausea/vomiting.
  4. Blood donation ≥400 mL within 3 months before screening.
  5. History of orthostatic hypotension, dysphagia.
  6. Gastrointestinal disorders affecting drug absorption.
  7. Cannot comply with unified diet requirements, lactose intolerance.
  8. Major surgery within 3 months before screening or planned surgery during study.
  9. Known hypersensitivity to study drug or placebo excipients.
  10. Alcohol or substance abuse history; positive drug-of-abuse screen or positive alcohol breath test.
  11. Excessive alcohol / tobacco / caffeine intake defined per protocol.
  12. Use of metformin or other biguanides within 3 months before screening; systemic glucocorticoids within 1 month before screening; CYP-modifying drugs within 30 days before screening; prescription/OTC/herbal products within 14 days before screening.
  13. Consumption of grapefruit / citrus fruits/juice within 5 days pre-screening and refusal to abstain during study.
  14. Vaccines or biological agents within 4 months pre-screening or planned during study.
  15. Participation in another interventional clinical trial within 3 months before screening.
  16. Difficult venous access, history of needle-phobia.
  17. Acute disease within 14 days prior to screening.
  18. Other conditions judged inappropriate for enrollment by investigator. Additional Exclusion for Part C (obese participants)： Fasting glucose ≥11.0 mmol/L or HbA1c ≥8.0%; secondary obesity, eating disorders, clinically significant cardiovascular disease, moderate-severe obstructive sleep apnea, active liver disease, significant renal impairment.

Repeated BP: SBP ≥160 mmHg or DBP ≥100 mmHg; ALT/AST >2×ULN; total bilirubin >1.5×ULN; eGFR <60 mL/min/1.73 m².

Weight-loss drugs, intensive weight-loss program within 3-month pre-screening; prior or planned bariatric surgery.

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: Sequential Assignment
  • Masking: Quadruple

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.
Experimental: Part-A-100 mg Cohort

Drug: IPG1094 Tablet 100 mg，single oral dose, fasted condition；Drug: Matching Placebo Tablet，single oral dose, fasted condition
Experimental: Part-A-300 mg Cohort

Drug: IPG1094 Tablet 300 mg，single oral dose, fasted condition；Drug: Matching Placebo Tablet，single oral dose, fasted condition
Experimental: Part-B1-50 mg QD Cohort

Drug: IPG1094 Tablet 50 mg QD, post-meal for 10 days；Drug: Matching Placebo Tablet QD, post-meal for 10 days
Experimental: Part-B2-100 mg QD Cohort

Drug: IPG1094 Tablet 100 mg QD, post-meal for 10 days；Drug: Matching Placebo Tablet QD, post-meal for 10 days
Experimental: Part-B3-200 mg QD Cohort

Drug: IPG1094 Tablet 200 mg QD, post-meal for 10 days；Drug: Matching Placebo Tablet QD, post-meal for 10 days
Experimental: Part-B4-100 mg BID Optional Cohort（optional, depends on safety/PK data）

Drug: IPG1094 Tablet 100 mg BID post-meal；Drug: Matching Placebo Tablet BID post-meal
Experimental: Part-C1-100 mg QD Obese Cohort

Drug: IPG1094 Tablet 100 mg QD post-meal for 28 days；Drug: Matching Placebo Tablet QD post-meal for 28 days
Experimental: Part-C2-200 mg QD Obese Cohort

Drug: IPG1094 Tablet 200 mg QD post-meal for 28 days；Drug: Matching Placebo Tablet QD post-meal for 28 days
Experimental: Part-C3-300 mg QD Obese Cohort

Drug: IPG1094 Tablet 300 mg QD post-meal for 90 days；Drug: Matching Placebo Tablet QD post-meal for 90 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
Part A: Maximum Observed Plasma Concentration (Cmax) of IPG1094 after single dose
Time Frame: Up to 96 hours post-dose

Single-dose maximum observed plasma concentration (Cmax) of IPG1094 following oral administration in healthy adult participants.
Up to 96 hours post-dose
Part A: Time to Maximum Plasma Concentration (Tmax) of IPG1094 after single dose
Time Frame: Up to 96 hours post-dose

Single-dose time to reach maximum plasma concentration (Tmax) of IPG1094 following oral administration in healthy adult participants.
Up to 96 hours post-dose
Part A: Terminal Elimination Half-life (t1/2) of IPG1094 after single dose
Time Frame: Up to 96 hours post-dose

Single-dose terminal elimination half-life (t1/2) of IPG1094 following oral administration in healthy adult participants.
Up to 96 hours post-dose
Part A: Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) of IPG1094 in Part A
Time Frame: Up to 96 hours post-dose

Single-dose AUC0-t of IPG1094 following oral administration in healthy adult participants.
Up to 96 hours post-dose
Part A: Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of IPG1094 in Part A
Time Frame: Up to 96 hours post-dose

Single-dose AUC0-inf of IPG1094 following oral administration in healthy adult participants.
Up to 96 hours post-dose
Part A: Apparent Oral Clearance (CL/F) of IPG1094 in Part A
Time Frame: Up to 96 hours post-dose

Single-dose apparent oral clearance (CL/F) of IPG1094 following oral administration in healthy adult participants.
Up to 96 hours post-dose
Steady-State Maximum Observed Plasma Concentration (Css,max) of IPG1094 in Part B
Time Frame: Day 1 to Day 13

Multiple-dose steady-state maximum observed plasma concentration (Css,max) of IPG1094 after repeated oral dosing in healthy adult participants.
Day 1 to Day 13
Time to Steady-State Maximum Plasma Concentration (Tss,max) of IPG1094 in Part B
Time Frame: Day 1 to Day 13

Multiple-dose time to steady-state maximum plasma concentration (Tss,max) of IPG1094 after repeated oral dosing in healthy adult participants.
Day 1 to Day 13
Area Under the Plasma Concentration-Time Curve Over One Dosing Interval at Steady State (AUC0-τ) of IPG1094 in Part B
Time Frame: Day 1 to Day 13

Multiple-dose steady-state AUC0-τ of IPG1094 after repeated oral dosing in healthy adult participants.
Day 1 to Day 13
Steady-State Apparent Oral Clearance (CLss/F) of IPG1094 in Part B
Time Frame: Day 1 to Day 13

Multiple-dose steady-state apparent oral clearance (CLss/F) of IPG1094 after repeated oral dosing in healthy adult participants.
Day 1 to Day 13
Accumulation Index Based on AUC (Rac,AUC) of IPG1094 in Part B
Time Frame: Day 1 to Day 13

Accumulation index calculated using AUC (Rac,AUC) of IPG1094 after repeated oral dosing in healthy adult participants.
Day 1 to Day 13
Accumulation Index Based on Cmax (Rac,Cmax) of IPG1094 in Part B
Time Frame: Day 1 to Day 13

Accumulation index calculated using Cmax(Rac,Cmax) of IPG1094 after repeated oral dosing in healthy adult participants.
Day 1 to Day 13
Safety indicators：adverse event
Time Frame: Day30 for 100/200 mg QD groups；Day90 for 300 mg QD group
Day30 for 100/200 mg QD groups；Day90 for 300 mg QD group

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
Time Frame
Part A: Safety indicators：adverse event
Time Frame: Up to 8-day follow-up
Up to 8-day follow-up
Part B: Safety indicators：adverse event
Time Frame: Up to Day16 follow-up
Up to Day16 follow-up
Part C: Percentage change from baseline in body weight on Day 30 for the 100 mg QD and 200 mg QD cohorts
Time Frame: Day30 for 100/200 mg QD groups
Day30 for 100/200 mg QD groups
Part C: Percentage change from baseline in body weight on Day 90 for the 300 mg QD cohort.
Time Frame: Day90 for 300 mg QD group
Day90 for 300 mg QD group
Part C: Changes from baseline in body weight (kg) across all scheduled visits
Time Frame: Day30 for 100/200 mg QD groups；Day90 for 300 mg QD group
Day30 for 100/200 mg QD groups；Day90 for 300 mg QD group
Part C: Changes from baseline BMI across all scheduled visits
Time Frame: Day30 for 100/200 mg QD groups；Day90 for 300 mg QD group
Day30 for 100/200 mg QD groups；Day90 for 300 mg QD group
Part C: Changes from baseline waist circumference across all scheduled visits
Time Frame: Day30 for 100/200 mg QD groups；Day90 for 300 mg QD group
Day30 for 100/200 mg QD groups；Day90 for 300 mg QD group
Part C: proportion of subjects achieving ≥5% weight loss from baseline at the endpoint assessment.
Time Frame: Day30 for 100/200 mg QD groups；Day90 for 300 mg QD group
Day30 for 100/200 mg QD groups；Day90 for 300 mg QD group
Part C: Cmax following first and last dosing.
Time Frame: Day30 for 100/200 mg QD groups；Day90 for 300 mg QD group
Day30 for 100/200 mg QD groups；Day90 for 300 mg QD group
Part C: Tmax following first and last dosing.
Time Frame: Day30 for 100/200 mg QD groups；Day90 for 300 mg QD group
Day30 for 100/200 mg QD groups；Day90 for 300 mg QD group
Part C: AUC₀-τ following the first dose and last dose
Time Frame: Day30 for 100/200 mg QD groups；Day90 for 300 mg QD group
Day30 for 100/200 mg QD groups；Day90 for 300 mg QD group
Part C: Accumulation index
Time Frame: Day30 for 100/200 mg QD groups；Day90 for 300 mg QD group
Day30 for 100/200 mg QD groups；Day90 for 300 mg QD group

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.
Nanjing Immunophage Biotech Co., Ltd

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Zhejiang 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 25, 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.
June 25, 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.
August 25, 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).
October 28, 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 9, 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 9, 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.
November 1, 2026

More Information

Terms related to this study

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.
  • IPG1094-HV-C002

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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