A Study of SRSD384 in Overweight or Obese Participants

NCT07557355 | Not Yet Recruiting Phase 1

• 1 other identifier: SRSD384-101
• Study Type: interventional
• Target: 78
• Locations: 0 countries
• Sites: N/A

Brief 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).

Conditions

Overweight , Obesity

Outcome Measures

Primary Outcomes (1)

• Incidence of treatment-emergent adverse events (TEAEs)

  168 days

Secondary Outcomes (3)

• Maximal concentration of SRSD384

  48 hours

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

  48 hours

• Time to the maximal concentration of SRSD384

  48 hours

Study Arms (4)

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

Interventions

SRSD384 injection DRUG

Administered S.C. per the protocol

SRSD384 injection (Part A); SRSD384 injection (Part B)

Placebo DRUG

Administered S.C. per the protocol

0.9% Sodium Chloride (Part A); 0.9% Sodium Chloride (Part B)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 SRSD216 and have previously received SRSD216.

Sponsors & Collaborators

• Sirius Therapeutics Co., Ltd.: lead

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Medical Director

CONTACT

+86 21 61207756; medical@siriusrna.com

Medical Director

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2026
• First Posted: April 29, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: April 29, 2026

Record last verified: 2026-04