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

January 7, 2026 updated by: Suzhou Sanegene Bio Inc.

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

45

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SGB-7342
Drug: SGB-7342
SC injection, single dose
Placebo Comparator: SGB-7342-Matching placebo
Drug: SGB-7342-Matching placebo
Normal saline (0.9% NaCl) in a matching volume, SC injection, single dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Participants with Adverse Events (AEs)
Time Frame: up to approximately 6 months
up to approximately 6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Maximum Observed Plasma Concentration (Cmax)
Time Frame: up to approximately 3 days
up to approximately 3 days
Area Under the Concentration-time Curve (AUC)
Time Frame: up to 3 days
up to 3 days
Weight change from baseline
Time Frame: up to approximately 12 months
up to approximately 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Suzhou Sanegene Bio Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 12, 2026

Primary Completion (Estimated)

October 28, 2026

Study Completion (Estimated)

April 14, 2027

Study Registration Dates

First Submitted

December 23, 2025

First Submitted That Met QC Criteria

January 6, 2026

First Posted (Estimated)

January 8, 2026

Study Record Updates

Last Update Posted (Actual)

January 9, 2026

Last Update Submitted That Met QC Criteria

January 7, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SGB-7342-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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