Actively Recruiting
The Efficacy and Safety of Efsubaglutide Alfa in Overweight/Obesity（SPARKLE）
Led by Shanghai Yinnuo Pharmaceutical Technology Co., Ltd. · Updated on 2025-12-02
200
Participants Needed
5
Research Sites
48 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
The Efficacy and Safety of Efsubaglutide Alfa in Overweight/Obesity（SPARKLE）
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing to follow visit schedules and provide written consent
- Male or female aged 18 to 75 years
- Obese (BMI 30.0 kg/m2 or higher) with or without other health conditions; or overweight (BMI 27.0 to less than 30.0 kg/m2) with at least one related condition such as pre-diabetes, hypertension, dyslipidemia, fatty liver, osteoarthritis, or sleep apnea
- Body weight change less than 5% controlled by diet and exercise in the 3 months before screening
- Women able to become pregnant and fertile men with partners able to become pregnant must use effective contraception during the study and for 3 months after the last dose
You will not qualify if you...
- Obesity caused by endocrine diseases or genetic mutations, including hypothalamic or pituitary obesity, hypothyroidism, Cushing's syndrome, insulinoma, acromegaly, or hypogonadism
- Known or suspected allergy to the study drug or similar drugs
- Diagnosed diabetes mellitus other than gestational diabetes
- Severe gastrointestinal disease, certain gastrointestinal surgeries, or significant stomach emptying problems
- Major heart or brain blood vessel diseases within 6 months before screening
- History of pancreatitis, gallbladder disease, or pancreatic injury
- Uncontrolled thyroid problems
- Personal or family history of certain thyroid cancers or endocrine disorders
- Frequent severe low blood sugar episodes in the past 6 months
- Active or recent significant cancer or potential malignancy
- Recent severe infection, trauma, or major surgery
- Severe psychiatric disorders or recent suicidal behavior
- Active infections including HIV, syphilis, hepatitis B or C
- Certain abnormal lab test results at screening
- Abnormal heart rhythm or ECG findings
- Uncontrolled high blood pressure
- Use of weight loss, glucose-lowering, or certain psychiatric medications within 3 months before screening
- Previous weight loss surgeries or treatments within 1 year
- Participation in other clinical trials with investigational treatments within 3 months
- Recent significant blood loss or transfusion
- Inability to have blood drawn
- Excessive alcohol use
- History or suspicion of drug abuse
- Recent marijuana use and unwillingness to abstain
- Pregnant or breastfeeding women
- Other conditions judged unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
Canopy Clinical Northern Beaches
Brookvale, Australia
Actively Recruiting
2
Canopy Clinical Sutherland Shire
Miranda, Australia
Actively Recruiting
3
Canopy Clinical Altona North
North Altona, Australia
Actively Recruiting
4
Fusion Clinical Research
Norwood, Australia
Actively Recruiting
5
Canopy Clinical Wollongong
Wollongong, Australia
Actively Recruiting
Research Team
Q
QINGHUA WANG
CONTACT
K
Karen Kaluhin
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
5
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here