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Not yet recruiting NCT07324850

A Study of SGB-7342 in Subjects With Obesity or Overweight

Phase I Interventional Obesity & Overweight

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: SGB-7342, SGB-7342-Matching placebo.
Who it may be relevant to
Registry conditions: Obesity & Overweight. Basic parameters: 18 years — 55 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
Center list to be confirmed — check the primary protocol.
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, Randomized, Double-blind, Placebo-controlled Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneously Administered SGB-7342 in Subjects With Obesity or Overweight

Overview

The purpose of this study is to evaluate the safety and tolerability of subcutaneously administered SGB-7342 in adult subjects with obesity and overweight.

Interventions

  • Drug SGB-7342
    SC injection, single dose
  • Drug SGB-7342-Matching placebo
    Normal saline (0.9% NaCl) in a matching volume, SC injection, single dose

Primary outcome measures

  • Number of Participants with Adverse Events (AEs) [Time frame: up to approximately 6 months]
Secondary outcome measures (3)
  • Maximum Observed Plasma Concentration (Cmax) [Time frame: up to approximately 3 days]
  • Area Under the Concentration-time Curve (AUC) [Time frame: up to 3 days]
  • Weight change from baseline [Time frame: up to approximately 12 months]

Eligibility criteria

Inclusion criteria

  • Body Mass Index (BMI) within the range of 26.0 to 35.0 kg/m²
  • Have a stable body weight within 3 months
  • Participants must agree to use adequate contraception from signing the informed consent until 6 months after completion of the follow-up visit.
  • Willing to comply with the protocol required visit schedule and visit requirements and provide written informed consent.

Exclusion criteria

  • A history of or a current surgical or medical condition that, in the opinion of the Investigator, may put the subject at significant risk (according to Investigator's judgment) or interfere with the subject's participation in the clinical study.
  • Use of GLP-1R agonists for any indication within 6 months prior to administering the investigational drug.
  • Use of non-GLP1R medications for weight loss within 3 months prior to administering the investigational drug.
  • Alanine aminotransferase (ALT), total bilirubin (TBIL), aspartate aminotransferase (AST)> 1.5 × ULN, and deemed clinically significant by the Investigators

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07324850 · SGB-7342-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗