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The Efficacy and Safety of Efsubaglutide Alfa in Overweight/Obesity（SPARKLE）

NCT07114419 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2025-12-02

No results posted yet for this study

Summary

This is a multicenter, double-blind, randomized, placebo-controlled phase Ⅱ study to evaluate the efficacy, safety, pharmacokinetics, and immunogenicity of YN-011 in subjects with overweight (27 kg/m2 ≤ BMI \< 30 kg/m2, with at least one comorbidity) or obesity (BMI ≥ 30 kg/m2, with or without comorbidities). The entire study period will consist of a 2-week screening period, a 22-week double-blind treatment period, and a 4-week off-treatment follow-up period

Conditions

  • Obesity and Overweight

Interventions

DRUG

Efsubaglutide Alfa 20 mg QW

Efsubaglutide Alfa 20 mg QW

DRUG

Efsubaglutide Alfa 40 mg QW

Efsubaglutide Alfa 40 mg QW

DRUG

Efsubaglutide Alfa 40 mg Q2W

Efsubaglutide Alfa 40 mg Q2W

DRUG

Efsubaglutide Alfa 80 mg QW

Efsubaglutide Alfa 80 mg QW

DRUG

Efsubaglutide Alfa 80 mg Q4W

Efsubaglutide Alfa 80 mg Q4W

OTHER

Placebo

Placebo

Sponsors & Collaborators

  • Shanghai Yinnuo Pharmaceutical Technology Co., Ltd.

    lead OTHER

Principal Investigators

  • Karen Kaluhin · Canopy Clinical Sutherland Shire

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-25
Primary Completion
2026-06-01
Completion
2026-08-01

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07114419 on ClinicalTrials.gov