NCT07557355Not yet recruitingPhase 1/2
A Study of SRSD384 in Overweight or Obese Participants
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
Source: ClinicalTrials.gov · Last updated 5 Jun 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 78 (estimated)
- First submitted
- 22 Apr 2026
- Start date
- 1 Jun 2026
- Primary completion date
- 31 Oct 2027
- Lead sponsor
- Sirius Therapeutics Co., Ltd.
- Diseases
- Obesity
- NCT number
- NCT07557355
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 78
- From 1 Jun 2026 to the primary completion date, 31 Oct 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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- Have previously completed or withdrawn from this study or any other study investigating SRSD384 and have previously received SRSD384.
Other illness
- 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;
Who the study is looking for
- 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.
Age in the registry: 18 years to 70 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Novatrials Coordinator of this site? Confirm its status | Charlestown | Australia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.