Health TrialsbyHealthPanel

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

This trial accepts healthy volunteers

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

Design model

Sequential

Treatments tested in this trial

  • SRSD384 injection

    Drug

    Administered S.C. per the protocol

  • Placebo

    Drug

    Administered S.C. per the protocol

Treatment groups

78 Participants
are divided into 4 treatment groups
Group A: SRSD384 injection (Part A)Experimental treatment 1 intervention
Group B: 0.9% Sodium Chloride (Part A)Placebo comparator 1 intervention
Group C: SRSD384 injection (Part B)Experimental treatment 1 intervention
Group D: 0.9% Sodium Chloride (Part B)Placebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of treatment-emergent adverse events (TEAEs)

Time frame
168 days

Secondary outcomes

1

Maximal concentration of SRSD384

Time frame
48 hours
2

Area under the concentration-time curve from time 0 to infinity of SRSD384

Time frame
48 hours
3

Time to the maximal concentration of SRSD384

Time frame
48 hours

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sirius Therapeutics Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: