A Study of SRSD384 in Overweight or Obese Participants
ConditionOverweight , Obesity
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorSirius Therapeutics Co., Ltd.
About this trial
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).
Eligibility criteria
Qualifiers
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.
Disqualifiers
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
Trial design
Treatments tested in this trial
- SRSD384 injection
- Placebo
Treatment groups
78 Participants
are divided into 4 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov