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NCT Number: NCT07557355

A Study of SRSD384 in Overweight or Obese Participants

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).

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

NovaTrials

Charlestown, New South Wales, 2290, Australia

Location contact

Deniz Kugulugil, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SRSD384 injection

Drug

Administered S.C. per the protocol

Placebo

Drug

Administered S.C. per the protocol

Primary outcomes

  1. Incidence of treatment-emergent adverse events (TEAEs)

    Time frame: 168 days

Secondary outcomes

  1. Maximal concentration of SRSD384

    Time frame: 48 hours

  2. Area under the concentration-time curve from time 0 to infinity of SRSD384

    Time frame: 48 hours

  3. Time to the maximal concentration of SRSD384

    Time frame: 48 hours

Study contacts

Contact information is provided by the study sponsor or research team.

Medical Director

CONTACT

[email protected]

+86 21 61207756

Medical Director

CONTACT

Sponsors and collaborators

Lead sponsor

Sirius Therapeutics Co., Ltd.

Industry

Registry information

Official study title

A Phase 1/2a, Randomized, Double Blind, Placebo Controlled, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneously Administered SRSD384 in Overweight or Obese Participants

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 29, 2026
Registry last updated
Jun 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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