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Study Evaluating ISM8969 in Healthy Adult and Elderly Participants and Obese Adult Participants at Risk of Cardiovascular Disease

NCT07581431 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-05-12

No results posted yet for this study

Summary

This is a single center, phase 1, randomized, double-blind, placebo-controlled sequential study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple ascending oral doses of ISM8969 in healthy adults and elderly participants and obese adult participants at risk of cardiovascular disease.

Conditions

  • Healthy Subjects (HS)
  • Elderly Participants
  • Obese Adult Participants at Risk of Cardiovascular Disease

Interventions

DRUG

ISM8969 tablets or placebo

Administration: Oral

DRUG

ISM8969 tablets or placebo

Administration: Oral

DRUG

ISM8969 tablets or placebo

Administration: Oral

Sponsors & Collaborators

  • InSilico Medicine Hong Kong Limited

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2026-05-29
Primary Completion
2027-01-29
Completion
2027-03-31
FDA Drug
Yes

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 NCT07581431 on ClinicalTrials.gov