Clinical trial NCT06530017: Clinical Trial to Evaluate the Ingested, Space Occupying Hydrogel Capsules for Simple Obesity Treatment
Official title: A Prospective, Multicenter, Randomized, Double-blind, Parallel Controlled, and Superiority Clinical Trial to Evaluate the Effectiveness and Safety of Ingested, Space Occupying Hydrogel Capsules for Simple Obesity Treatment
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Simple Obesity
Lead sponsor: IMEIK Technology Development Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-07-31
Enrollment: 440
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the effectiveness and safety of Ingested, Space Occupying hydrogel capsules for simple obesity treatment

Detailed description: Ingested, Space Occupying hydrogel capsules is indicated to aid in simple obesity treatment with a Body Mass Index (BMI) of 28-40 kg/m2，using under the guidance of a physician.This clinical trial seek to evaluate the efficacy and safety of Ingested, Space Occupying hydrogel capsules for simple obesity treatment.

Eligibility criteria: Inclusion Criteria:

* The subjects have a BMI≥28kg/m²and BMI≤40kg/m²

Exclusion Criteria:

* Individuals with secondary obesity, such as hypothyroidism, Cushing's syndrome, etc.
* Those who have undergo surgical method within the past 3 months prior to screening, or plan to lose weight by surgical method during the clinical trial.
* Weight loss exceeding \>5% (self-report) within the past 3 months prior to screening.
* Individuals with uncontrolled diabetes mellitus (fasting blood glucose≥7.0mmol/L or glucose loading after 2 hours blood glucose≥11.1mmol/L or glycosylated hemoglobin≥7.0%) .
* Within 1 month before screening or planning to use drugs or health products that may cause significant weight gain or loss during the clinical trials, including biguanides,α-glycosidase inhibitors, SGLT-2 inhibitors, GLP-1 receptor agonists, leptinoid drugs, sympathomimetic drugs, esterase inhibitors, lipolytic injections, sulfonamides, systemic glucocorticoids (more than 1 week), estrogen, thyroid hormones or preparations, antipsychotic or antidepressant drugs, Chinese patent medicines and Chinese herbal medicines, etc.
* Patients with central nervous system diseases (including but not limited to any type of seizures or strokes) and other related neurological diseases or mental illnesses.
* Those who have suffered or are suffering from swallowing disorders, gastroesophageal reflux disease, gastric or duodenal ulcers, gastroparesis, esophageal and gastric varices, intestinal obstruction or suspected small bowel adhesions, pyloric obstruction, Crohn's disease, ulcerative colitis and other diseases, acute/chronic pancreatitis, as well as a history of gastrointestinal surgery (except those related to appendectomy and intestinal polypectomy), abdominal radiation therapy, and gastrointestinal bleeding.
* Those who have AIDS or a history of cancer within the past 5 years.
* Patients with poorly controlled hypertension, i.e., systolic blood pressure (SBP) \> 165mmHg and/or diastolic blood pressure (DBP) \>95mmHg.
* Patients with renal insufficiency, i.e., estimated glomerular filtration rate (eGFR\<30 ml/min/1.73m2)\* calculated by the CKD-EPI creatinine equation as defined by the KDIGO 2012 classification.
* Patients with impaired liver function, that is, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 3 times the upper limit of normal, or total bilirubin (TBIL) \> 3 times the upper limit of normal.
* Those who stop smoking within the past 6 months before the screening period or consider stop smoking during the trial.
* Those who have planned surgery in the past 6 months.
* Pregnant or breastfeeding, planning to become pregnant during the trial (or males unwilling to use an adequate method of contraception), or having a positive pregnancy test result during the screening period.
* Individuals with a history of allergies to cellulose, titanium dioxide, citrate acid and succinic acid.
* Those with severe cardiovascular and cerebrovascular diseases or systemic failure that affects treatment.
* The investigator judges that the subject has other systemic diseases that are not suitable for participating in this trial, and the abnormal laboratory test results are determined by the investigator whether they can be enrolled.
* Participated in clinical trials of other drugs or medical devices within 30 days prior to the screening period.
* Other circumstances that the investigator deems inappropriate to participate in this trial.

Primary outcomes:
measure: Weight loss percentage from baseline at Week 24
timeFrame: 24 weeks
measure: Response rate of weight loss at week 24 after enrollment
timeFrame: 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Friendship Hospital,Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Peking University Shougang Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Shijitan Hospital, Capital Medical University
state: Beijing
city: Shijiazhuang
country: China
facility: The First Hospital of Hebei Medical University
state: Hebei
city: Changsha
country: China
facility: The Third XiangYa Hospital of Central South University
state: Hunan
city: Shenyang
country: China
facility: The First Affiliated Hospital of China Medical University
state: Liaoning
city: Shenyang
country: China
facility: Shengjing Hospital Of China Medical University
state: Liaoning
city: Luoyang
country: China
facility: The First Affiliated Hospital of Henan University of Science & Technology
state: Luoyang
city: Jinan
country: China
facility: QILU Hospital Of Shandong University
state: Shandong
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital
state: Tianjin
Study officials:
affiliation: Beijing Friendship Hospital
name: Peng Li, M.D.
role: PRINCIPAL_INVESTIGATOR
References: