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

NCT07114419 | Recruiting Phase 2

• 1 other identifier: YN012-II-W204-AU
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 5

Brief 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

Outcome Measures

Primary Outcomes (1)

• Percentage change (%) of body weight from baseline after subcutaneous administration of YN-011 for 22 weeks

  22 weeks

Secondary Outcomes (24)

• Proportion of subjects with body weight loss ≥ 5%, ≥ 10%, and ≥ 15% from baseline after subcutaneous

  22 weeks

• Absolute change from baseline in body weight (Kg) after subcutaneous administration for 22 weeks

  22 weeks

• Changes from baseline in BMI after subcutaneous administration for 22 weeks

  22 weeks

• Changes from baseline in waist to hip circumference ratio after subcutaneous administration for 22 weeks

  22 weeks

• Changes from baseline in waist to height ratio after subcutaneous administration of YN-011 for 22 weeks

  22 weeks

Study Arms (5)

Efsubaglutide 20 mg Quaque Week (QW）

EXPERIMENTAL

The drug is administered once weekly, starting with a titration dose of 1 mg. The dose is up-titrated every 2 weeks in the sequence of 1 mg → 5 mg → 10 mg → 20 mg, reaching the target dose of 20 mg, the total treatment last for 22weeks.

Drug: Efsubaglutide Alfa 20 mg QW; Other: Placebo

Efsubaglutide 40 mg QW

EXPERIMENTAL

The drug is administered once weekly, starting with a titration dose of 1 mg. The dose is up-titrated every 2 weeks in the sequence of 1 mg → 5 mg → 10 mg → 20 → 40mg, reaching the target dose of 40 mg, the total treatment last for 22weeks.

Drug: Efsubaglutide Alfa 40 mg QW; Other: Placebo

Efsubaglutide Alfa 40 mg Q2W

EXPERIMENTAL

The drug is administered once weekly, starting with a titration dose of 1 mg. The dose is up-titrated every 2 weeks in the sequence of 1 mg → 5 mg → 10 mg → 20 → 40mg,when reaching to target dose of 40 mg, administered the drug every 2weeks. the total treatment last for 22weeks.

Drug: Efsubaglutide Alfa 40 mg Q2W; Other: Placebo

Efsubaglutide Alfa 80 mg QW

EXPERIMENTAL

The drug is administered once weekly, starting with a titration dose of 1 mg. The dose is up-titrated every 2 weeks in the sequence of 1 mg → 5 mg → 10 mg → 20 → 40mg→ 80mg, reaching the target dose of 80 mg, the total treatment last for 22weeks.

Drug: Efsubaglutide Alfa 80 mg QW; Other: Placebo

Efsubaglutide Alfa 80 mg Q4W

EXPERIMENTAL

The drug is administered once weekly, starting with a titration dose of 1 mg. The dose is up-titrated every 2 weeks in the sequence of 1 mg → 5 mg → 10 mg → 20 → 40mg→ 80mg,when reaching to target dose of 80 mg, administered the drug every 4weeks. the total treatment last for 22weeks.

Drug: Efsubaglutide Alfa 80 mg Q4W; Other: Placebo

Interventions

Efsubaglutide Alfa 20 mg QW DRUG

Efsubaglutide Alfa 20 mg QW

Efsubaglutide 20 mg Quaque Week (QW）

Efsubaglutide Alfa 40 mg QW DRUG

Efsubaglutide Alfa 40 mg QW

Efsubaglutide 40 mg QW

Efsubaglutide Alfa 40 mg Q2W DRUG

Efsubaglutide Alfa 40 mg Q2W

Efsubaglutide Alfa 40 mg Q2W

Efsubaglutide Alfa 80 mg QW DRUG

Efsubaglutide Alfa 80 mg QW

Efsubaglutide Alfa 80 mg QW

Efsubaglutide Alfa 80 mg Q4W DRUG

Efsubaglutide Alfa 80 mg Q4W

Efsubaglutide Alfa 80 mg Q4W

Placebo OTHER

Placebo

Efsubaglutide 20 mg Quaque Week (QW）; Efsubaglutide 40 mg QW; Efsubaglutide Alfa 40 mg Q2W; Efsubaglutide Alfa 80 mg Q4W; Efsubaglutide Alfa 80 mg QW

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willing to comply with protocol required visit schedule and visit requirements and provide written informed consent form (ICF);
• Male or female subjects, aged 18 to 75 years (both inclusive) at the time of signing the ICF;
• Obese: BMI ≥ 30.0 kg/m2, with or without comorbidities; Or overweight: 27.0 kg/m2 ≤ BMI \< 30.0 kg/m2, with at least one of the following weight-related comorbidities: pre-diabetes, hypertension, dyslipidemia, fatty liver, osteoarthritis, or obesity-induced obstructive sleep apnea syndrome (If the subject has only fatty liver as a comorbidity, imaging results within the 3 months prior to screening are required for fatty liver);
• A self-reported change in body weight less than 5.0% controlled with diet and exercise within 3 months before screening;
• Women of childbearing potential (WOCBP) and fertile males with WOCBP partners must use highly effective contraception methods throughout the study (from the signing of ICF to 3 months after the last dose of investigational medicinal products).

You may not qualify if:

• Obesity caused by endocrine disease or monogenic mutation, including but not limited to hypothalamic obesity, pituitary obesity, hypothyroidism-related obesity, Cushing's syndrome, insulinoma, acromegaly or hypogonadism;
• Known or suspected allergy to the investigational medicinal product, its components or drugs of the same class;
• Previously diagnosed diabetes mellitus (including type 1 diabetes mellitus, type 2 diabetes mellitus, diabetes mellitus due to pancreatic damage, or other types of diabetes mellitus \[except gestational diabetes mellitus\]);
• History of severe gastrointestinal disease (e.g., active ulcers), or gastrointestinal surgery (except for appendectomy, cholecystectomy, or other gastrointestinal endoscopic surgeries deemed by the investigator to have no significant impact on gastrointestinal motility), or clinically significant gastric emptying abnormalities (e.g., pyloric obstruction, gastroparesis), or long-term use of drugs with direct effects on gastrointestinal motility within 6 months before screening, or those who were not suitable for participating in this study at the investigator's discretion;
• History of significant cardiovascular or cerebrovascular disease within 6 months before screening, including but not limited to:1) Myocardial infarction, coronary angioplasty or bypass grafting, heart valve disease or heart valve repair, clinically significant arrhythmias requiring treatment, angina, transient ischemic attack, cerebrovascular accident or others; 2)Congestive heart failure classified as Grade III or IV by the New York Heart Association (NYHA) (refer to Appendix 3);
• History of acute or chronic pancreatitis, symptomatic gallbladder disease (subjects who have undergone cholecystectomy and have stable condition post-surgery are excluded), or pancreatic injury and other factors that may lead to high risk of pancreatitis;
• Presence of hyperthyroidism; or hypothyroidism that has not been controlled with a stable medication dose (defined as a stable dose for 3 months or longer);
• Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2);
• Subjects who have experienced two or more hypoglycemic events within 6 months prior to screening, defined as blood glucose \< 2.8 mmol/L (50.4 mg/dl) or blood glucose not reaching \< 2.8 mmol/L (50.4 mg/dl) but with significant hypoglycemia symptoms (manifested by sympathetic arousal \[e.g., palpitations, anxiety, sweating, dizziness, shaking of the hands, feeling of hunger, etc.\] and CNS symptoms \[e.g., altered mentation, cognitive disturbances, seizures and coma\]);
• History of an active or untreated malignancy or are in remission from a clinically significant malignancy (other than basal- or squamous-cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer) for less than 5 years; or there is a potential malignancy during screening;
• History of severe infection or severe trauma within 3 months prior to screening, or undergoing major surgery or not fully recovering from surgery, and the investigator determines that the participant is unsuitable for this study;
• History of significant active or unstable major depressive disorder or other severe psychiatric disorder (for example, schizophrenia, bipolar disorder, or other serious mood or anxiety disorder) within 2 years prior to screening;
• Previous suicidal tendency or suicidal behavior;
• Suicidal ideation corresponding to type 4 or 5 on the C-SSRS at screening;
• PHQ-9 questionnaire ≥ 15 points at screening;

Sponsors & Collaborators

• Shanghai Yinnuo Pharmaceutical Technology Co., Ltd.: lead

Study Sites (5)

Canopy Clinical Northern Beaches

Brookvale, Australia

RECRUITING

Canopy Clinical Sutherland Shire

Miranda, Australia

RECRUITING

Canopy Clinical Altona North

North Altona, Australia

RECRUITING

Fusion Clinical Research

Norwood, Australia

RECRUITING

Canopy Clinical Wollongong

Wollongong, Australia

RECRUITING

MeSH Terms

Conditions

Obesity; Overweight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Karen Kaluhin

  Canopy Clinical Sutherland Shire

  PRINCIPAL INVESTIGATOR

Central Study Contacts

QINGHUA WANG

CONTACT

862168788225; dr.qwang@innogenpharm.com

Karen Kaluhin

CONTACT

02 8357 5242; kkaluhin@canopycrcom.au

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2025
• First Posted: August 11, 2025
• Study Start: August 25, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: December 2, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

AU (5)