Overweight or Obesity
Conditions
Brief summary
To evaluate the efficacy and safety of SYH2069 injection compared with placebo in obese Non-diabetic Participants after 28 weeks of treatment.
Interventions
0.6ml , 1.2ml , administered subcutaneously (SC)，Administer the drug according to the clinical trial protocol
0.6ml , 1.2ml , SC，Administer the drug according to the clinical trial protocol
Sponsors
CSPC Ouyi Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Intervention model description
A multicenter, randomized, double-blind, placebo parallel-controlled Phase II clinical study
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 1.Male or female participants, 18-65 years of age at the time of signing informed consent; * 2.At screening visit, 28.0 kg/m\^2≤BMI≤ 40.0 kg/m\^2; * 3.Maintained consistent diet and exercise habits with stable body weight within the 12 weeks prior to screening (self-reported weight variation \<5%).; * 4.Able to understand and comply with trial procedures, voluntarily participate in the trial, and provide written informed consent (ICF).
Exclusion criteria
* 1\. Participants with a history of diabetes mellitus or hypoglycemic episodes; * 2\. Participants with obesity caused by known single-gene mutations, other medical conditions, or medications, or weight gain not resulting from increased adipose tissue mass; * 3\. Use of any medications or products that alter body weight and interfere with weight assessment within 3 months prior to screening; * 4\. Prior bariatric surgery or weight-loss interventions, or plan to receive any bariatric surgery or weight-loss intervention during the trial. * 5\. History of or known hypersensitivity to any active ingredient or excipient of the investigational product; known allergic diathesis; or severe allergic diseases present at screening. * 6\. Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN-2). * 7\. Prior history of acute or chronic pancreatitis or pancreatic injury; history of acute gallbladder disease within 1 year prior to screening; . * 8\. History of severe cardiovascular or cerebrovascular events within 6 months prior to screening. * 9\. Prior severe respiratory, central nervous system or psychiatric disorders; any suicide attempts within the past 2 years, or suicidal ideation within 3 months prior to screening or during screening; * 10\. Any treated or untreated malignancy diagnosed from 5 years before screening through randomization (clinically cured basal cell carcinoma or carcinoma in situ are exempted). * 11\. Clinically significant hematological diseases, hemolytic or red blood cell disorders, or baseline conditions that interfere with HbA1c measurement at screening or randomization. * 12\. Participants with inadequately controlled blood pressure * 13\. History of alcohol abuse, substance misuse or illicit drug use prior to screening * 14\. Severe trauma, severe or acute infection occurring within 3 months prior to screening or between screening and randomization * 15\. Prior clinical trial exposure to study drug within 90 days pre-screening or 5 drug half-lives, whichever is longer. * 16\. Pregnancy or lactation; fertile male or female participants and their partners who fail to use effective contraception throughout the trial and for 3 months following the end of treatment. * 17\. Any other conditions that, in the investigator's judgment, render the participant unsuitable for this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Relative percentage change in body weight from baseline at of treatment at 28 weeks of treatment | 28 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of subjects with a weight loss of ≥5% , 10%, 15% from baseline at 28 weeks of treatment | Baseline through Week 28 |
| Change from baseline in body Weight | Week 2, 4, 8, 12, 16, 20, 24 and 28 |
| Changes from baseline in waist circumference | Baseline through Week 28 |
| Changes from baseline in hip circumference | Baseline through Week 28 |
| Changes from baseline in waist-to-hip ratio | Baseline through Week 28 |
| Changes from baseline in Body Mass Index (BMI) | Baseline through Week 28 |
| Changes from baseline in Hemoglobin A1c (HbA1c) | Baseline through Week 28 |
| Changes from baseline in fasting plasma glucose (FPG) | Baseline through Week 28 |
| Changes from baseline in fasting C-peptide | Baseline through Week 28 |
| Changes from baseline in Homeostatic Model Assessment of Insulin Resistance(HOMA-IRs) | Baseline through Week 28 |
| Changes from baseline in systolic blood pressure | Baseline through Week 28 |
| Changes from baseline in diastolic blood pressure | Baseline through Week 28 |
| Changes from baseline in lipid parameters (TC, LDL-C, HDL-C, non-HDL-C, TG, ApoB) | Baseline through Week 28 |
| Changes from baseline in high sensitivity C reactive protein (hs-CRP) | Baseline through Week 28 |
| Changes from baseline in urinary albumin-to-creatinine ratio (UACR) | Baseline through Week 28 |
| The incidence rate of adverse events (AEs) | Baseline through Week 31 |
| Plasma concentrations & PK parameters: Peak Time (Tmax) | Baseline through Week 31 |
| Plasma concentrations & PK parameters: Area under the plasma concentration versus time curve(AUC) : AUClast, AUC0-168h, AUC0-336h | Baseline through Week 31 |
| Plasma concentrations & PK parameters: Peak Plasma Concentration (Cmax) | Baseline through Week 31 |
Countries
China
Contacts
CONTACTClinical Trials Information Group Officer
Outcome results
None listed