Overweight , ObesityPhase 1/2NCT07557355
A Study of SRSD384 in Overweight or Obese Participants
A Phase 1/2 study testing SRSD384 injection in people with Overweight , Obesity, run by Sirius Therapeutics Co., Ltd. at 1 site in Australia.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight , Obesity
- What is being tested?
- SRSD384 injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 78 participants
- Where
- 1 siteAustralia
- Study dates
- Jun 2026to Oct 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Medical Director contact
Australia1 site
NovaTrials
Charlestown, New South Wales, 2290
Deniz Kugulugil, MD
About this study
Official 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
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).
- Conditions
- Overweight , Obesity
- Being tested
- SRSD384 injection, Placebo
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SRSD384 injectionDrug
Administered S.C. per the protocol
PlaceboDrug
Administered S.C. per the protocol
| Study group | Role | What they receive |
|---|---|---|
| SRSD384 injection (Part A) | Experimental | Not described Receives: Drug: SRSD384 injection |
| 0.9% Sodium Chloride (Part A) | Placebo comparator | Not described Receives: Drug: Placebo |
| SRSD384 injection (Part B) | Experimental | Not described Receives: Drug: SRSD384 injection |
| 0.9% Sodium Chloride (Part B) | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment-emergent adverse events (TEAEs)
Measured: 168 days
Secondary outcomes (3)
Maximal concentration of SRSD384
Measured: 48 hours
Area under the concentration-time curve from time 0 to infinity of SRSD384
Measured: 48 hours
Time to the maximal concentration of SRSD384
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2026
- Study startJun 2026 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight , ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sirius Therapeutics Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07557355
- Sponsor's protocol ID
- SRSD384-101
- Status last verified
- Jun 2026
- First submitted
- 22 Apr 2026
- Last updated
- 5 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07557355
- Acronym / sponsor ID
- SRSD384-101
- Conditions
- Overweight , Obesity
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Sirius Therapeutics Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jun 2026 (estimated)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 29 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| SRSD384 injection (Part A) | Experimental | Drug: SRSD384 injection |
| 0.9% Sodium Chloride (Part A) | Placebo comparator | Drug: Placebo |
| SRSD384 injection (Part B) | Experimental | Drug: SRSD384 injection |
| 0.9% Sodium Chloride (Part B) | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SRSD384 injectionAdministered S.C. per the protocol | Drug | SRSD384 injection (Part A), SRSD384 injection (Part B) |
| PlaceboAdministered S.C. per the protocol | Drug | 0.9% Sodium Chloride (Part A), 0.9% Sodium Chloride (Part B) |
Primary outcome
Incidence of treatment-emergent adverse events (TEAEs)
Time frame: 168 days
3 secondary outcomes
Maximal concentration of SRSD384
Time frame: 48 hours
Area under the concentration-time curve from time 0 to infinity of SRSD384
Time frame: 48 hours
Time to the maximal concentration of SRSD384
Time frame: 48 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Medical Director contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing SRSD384 injection in people with Overweight , Obesity, run by Sirius Therapeutics Co., Ltd. at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Medical Director (+86 21 61207756, medical@siriusrna.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of treatment-emergent adverse events (TEAEs) (time frame: 168 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2026.