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

ConditionObesity & Overweight
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorSuzhou Sanegene Bio Inc.

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • SGB-7342

    Drug

    SC injection, single dose

  • SGB-7342-Matching placebo

    Drug

    Normal saline (0.9% NaCl) in a matching volume, SC injection, single dose

Treatment groups

45 Participants
are divided into 2 treatment groups
Group A: SGB-7342Experimental treatment 1 intervention
Group B: SGB-7342-Matching placeboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Number of Participants with Adverse Events (AEs)

Time frame
up to approximately 6 months

Secondary outcomes

1

Maximum Observed Plasma Concentration (Cmax)

Time frame
up to approximately 3 days
2

Area Under the Concentration-time Curve (AUC)

Time frame
up to 3 days
3

Weight change from baseline

Time frame
up to approximately 12 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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

Suzhou Sanegene Bio Inc.

Lead sponsor

Source ClinicalTrials.gov

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