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NCT07935291

Study of IPG1094 Tablets in Chinese Healthy Adults and Obese Adults

StatusNot Yet Recruiting
PhasePhase 1
Primary completion (estimated)
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Record History

All 1 version: 1 with changes below.

  1. Study First Submitted

Endpoints

Primary

Part A: Maximum Observed Plasma Concentration (Cmax) of IPG1094 after single dose
Timeframe: Up to 96 hours post-dose
Part A: Time to Maximum Plasma Concentration (Tmax) of IPG1094 after single dose
Timeframe: Up to 96 hours post-dose
Part A: Terminal Elimination Half-life (t1/2) of IPG1094 after single dose
Timeframe: 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
Timeframe: 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
Timeframe: Up to 96 hours post-dose
Part A: Apparent Oral Clearance (CL/F) of IPG1094 in Part A
Timeframe: Up to 96 hours post-dose
Steady-State Maximum Observed Plasma Concentration (Css,max) of IPG1094 in Part B
Timeframe: Day 1 to Day 13
Time to Steady-State Maximum Plasma Concentration (Tss,max) of IPG1094 in Part B
Timeframe: 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
Timeframe: Day 1 to Day 13
Steady-State Apparent Oral Clearance (CLss/F) of IPG1094 in Part B
Timeframe: Day 1 to Day 13
Accumulation Index Based on AUC (Rac,AUC) of IPG1094 in Part B
Timeframe: Day 1 to Day 13
Accumulation Index Based on Cmax (Rac,Cmax) of IPG1094 in Part B
Timeframe: Day 1 to Day 13
Safety indicators:adverse event
Timeframe: Day30 for 100/200 mg QD groups;Day90 for 300 mg QD group

Secondary (12)

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

Arms and interventions

Part-A-100 mg CohortExperimental

Drug: IPG1094 Tablet 100 mg,single oral dose, fasted condition;Drug: Matching Placebo Tablet,single oral dose, fasted condition

Part-A-300 mg CohortExperimental

Drug: IPG1094 Tablet 300 mg,single oral dose, fasted condition;Drug: Matching Placebo Tablet,single oral dose, fasted condition

Part-B1-50 mg QD CohortExperimental

Drug: IPG1094 Tablet 50 mg QD, post-meal for 10 days;Drug: Matching Placebo Tablet QD, post-meal for 10 days

Part-B2-100 mg QD CohortExperimental

Drug: IPG1094 Tablet 100 mg QD, post-meal for 10 days;Drug: Matching Placebo Tablet QD, post-meal for 10 days

Part-B3-200 mg QD CohortExperimental

Drug: IPG1094 Tablet 200 mg QD, post-meal for 10 days;Drug: Matching Placebo Tablet QD, post-meal for 10 days

Part-B4-100 mg BID Optional Cohort(optional, depends on safety/PK data)Experimental

Drug: IPG1094 Tablet 100 mg BID post-meal;Drug: Matching Placebo Tablet BID post-meal

Part-C1-100 mg QD Obese CohortExperimental

Drug: IPG1094 Tablet 100 mg QD post-meal for 28 days;Drug: Matching Placebo Tablet QD post-meal for 28 days

Part-C2-200 mg QD Obese CohortExperimental

Drug: IPG1094 Tablet 200 mg QD post-meal for 28 days;Drug: Matching Placebo Tablet QD post-meal for 28 days

Part-C3-300 mg QD Obese CohortExperimental

Drug: IPG1094 Tablet 300 mg QD post-meal for 90 days;Drug: Matching Placebo Tablet QD post-meal for 90 days

Drugs: IPG1094 Tablet and matching Placebo

Sites

1 site in 1 country

  • Zhejiang HospitalHangzhou, Zhejiang, China