A Study of SRSD384 in Overweight or Obese Participants
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SRSD384 injection, Placebo.
- Who it may be relevant to
- Registry conditions: Overweight , Obesity. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Australia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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).
Interventions
- Drug SRSD384 injection
Administered S.C. per the protocol - Drug Placebo
Administered S.C. per the protocol
Primary outcome measures
- Incidence of treatment-emergent adverse events (TEAEs) [Time frame: 168 days]
Secondary outcome measures (3)
- 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]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Sequential
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Australia · 1 center
- NovaTrials — Charlestown
Identifiers
NCT: NCT07557355 · SRSD384-101