Testing the injected drug SRSD384 in adults who are overweight or obese
Tests SRSD384 injections in adults with overweight or obesity, including with tirzepatide.
Plain-language title generated from the registry record
Registry title: A Study of SRSD384 in Overweight or Obese Participants
Key facts
- Where
- Charlestown, AustraliaSee the site
- Phase
- Phase 1/2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 70 years old?
Source: NCT07557355, who can take part
Where in Australia
- NovatrialsCharlestown, AustraliaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Sirius Therapeutics Co., Ltd.
- Trial code
- NCT07557355
- Record updated
- 5 June 2026
- Original description
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).Read full original descriptionShow less
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
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).
Inclusion: 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: 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; 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; 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); History of clinically significant hypersensitivity, intolerance, or allergy to any oligonucleotide or GalNAc as determined by the investigator.