A Study of SGB-7342 in Subjects With Obesity or Overweight | NCT07324850

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

NCT07324850

Sponsor

Suzhou Sanegene Bio Inc.

Status

Not yet recruiting

Last Update Posted

Jan 9, 2026Actual

Enrollment

45Estimated

Phase

Phase 1

Conditions

Obesity & Overweight

Interventions

SGB-7342
SGB-7342-Matching placebo

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2026

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 12, 2026Estimated

Primary Completion Date

Oct 28, 2026Estimated

Completion Date

Apr 14, 2027Estimated

First Submitted Date

Dec 23, 2025

First Submission Date that Met QC Criteria

Jan 6, 2026

First Posted Date

Jan 8, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 7, 2026

Last Update Posted Date

Jan 9, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

45Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
SGB-7342	Experimental		Drug: SGB-7342
SGB-7342-Matching placebo	Placebo Comparator		Drug: SGB-7342-Matching placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
SGB-7342	Drug	SC injection, single dose	SGB-7342
SGB-7342-Matching placebo

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Role	Phone	Extension	Email
SGB.clinical	Contact	+086 021-60209828		SGB.clinical@sanegenebio.com

Condition Browse Module

MeSH Terms

ID	Term
D009765	Obesity
D050177	Overweight

Ancestor Terms

ID	Term
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases
D001835	Body Weight

Browse Leaves

Not provided

Browse Branches

Not provided