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A Phase 1, Double-blind, Randomized Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of Single Dose and Multiple Doses of CG-0416 in Healthy Participants.

NCT07724431 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2026-07-24

No results posted yet for this study

Summary

A Phase 1, double-blind, randomized study to evaluate the safety, tolerability, pharmacodynamics, and pharmacokinetics of single dose and multiple doses of CG-0416 in healthy participants. HongKong Curegene Innovation Co. Limited is developing the study drug CG-0416 as a potential new treatment for overweight and obesity. The purpose of this research is to investigate the safety, tolerability (if any side effects occur), pharmacokinetics (the amount of study drug or any of its breakdown products in your body) and pharmacodynamics (how the study drug affects your body), of single and multiple oral doses of a study drug called CG-0416.

Conditions

  • Overweight and Obesity

Interventions

DRUG

CG-0416

CG-0416 is a novel selective, liver-directed thyroid hormone receptor beta (THR-β) agonist, given orally once daily.

Sponsors & Collaborators

  • HongKong Curegene Innovation Co., Limited

    lead INDUSTRY

Principal Investigators

  • Philip Ryan, MD · Nucleus Network Pty Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-07-31
Primary Completion
2027-03-31
Completion
2027-04-30

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07724431 on ClinicalTrials.gov