Ireland
--:--IST
Starting soon Phase 1/2

A Study of SRSD384 in Overweight or Obese Participants

NCT07557355 · tracked via the Priya Life Science Australia tracker
Phase
Phase 1/2
Started
2026-06
Last updated
2026-06-05

Condition(s) studied

Overweight , Obesity

Investigational drug(s) / intervention(s)

SRSD384 injectionPlacebo

SRSD384 injection: Administered S.C. per the protocol

Placebo: Administered S.C. per the protocol

Study summary

This is a two-part study, intended to investigate the safety, tolerability, characteristics of PK and PD of single SC dose of SRSD384 alone in overweight or obese participants (Part A) and in combination with tirzepatide in overweight or obese participants with T2DM (Part B).

Eligibility

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
Accepted
Inclusion Criteria: * Able to comprehend and willing to sign an informed consent form (ICF) and to abide by the study restrictions; * Males or females; * Body mass index (BMI) between 27.0 and 40.0 kg/m2, inclusive; * Male subjects are not allowed to donate sperm, and female subjects are not allowed to donate eggs from the time the ICF is signed until at least 3 months after the last follow-up. Exclusion Criteria: * Obesity attributable, in the investigator's opinion, to medication use, endocrinologic or monogenic disorders; * Having a significant medical history or clinical manifestations related to any allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine (other than overweight or obesity), or psychiatric conditions that are severe or unstable (determined by the investigator or medically qualified designee); * Evidence of active cancer within 2 years prior to screening (non-melanoma skin cancer, localized prostate cancer treated with curative intent, or other in situ carcinoma that does not require systemic therapy and is considered cured for at least 1 year is allowed); * Acute febrile illness within 7 days prior to randomization or evidence of active infection * Any major surgery within 3 months prior to screening or plan to have any major surgery during the study; * History of clinically significant hypersensitivity, intolerance, or allergy to any oligonucleotide or GalNAc as determined by the investigator; * Receipt of an investigational drug within 30 days or 5 half-lives of that drug, whichever is longer, prior to dose administration in this study; * Have previously completed or withdrawn from this study or any other study investigating SRSD384 and have previously received SRSD384.

Primary outcome measure(s)

  • Incidence of treatment-emergent adverse events (TEAEs) — 168 days

Trial sites (1)

FacilityCityRegionStatus
NovaTrials Charlestown New South Wales
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07557355 on ClinicalTrials.gov ↗ ← All trials in Australia