Clinical Trial to Evaluate the Ingested, Space Occupying Hydrogel Capsules for Simple Obesity Treatment

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Simple Obesity
• Intervention / Treatment: Device: Ingested, Space Occupying hydrogel capsules; Device: placebo

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.

• Study Type: Interventional
• Enrollment (Estimated): 440
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Wei Li; Phone Number: 13520464757; Email: liwei@imeik.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100032
      • Beijing Friendship Hospital,Capital Medical University
    • Beijing, Beijing, China, 100043
      • Peking University Shougang Hospital
    • Beijing, Beijing, China, 100071
      • Beijing Shijitan Hospital, Capital Medical University
  • Hebei
    • Shijiazhuang, Hebei, China, 050023
      • The First Hospital of Hebei Medical University
  • Hunan
    • Changsha, Hunan, China, 410013
      • The Third Xiangya Hospital of Central South University
  • Liaoning
    • Shenyang, Liaoning, China, 110004
      • Shengjing Hospital Of China Medical University
    • Shenyang, Liaoning, China, 110001
      • The First Affiliated Hospital of China Medical University
  • Luoyang
    • Luoyang, Luoyang, China, 471003
      • The First Affiliated Hospital of Henan University of Science & Technology
  • Shandong
    • Jinan, Shandong, China, 250012
      • Qilu Hospital of Shandong University
  • Tianjin
    • Tianjin, Tianjin, China, 300070
      • Tianjin Medical University General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Subjects in the Study group will be treated with Ingested, Space Occupying hydrogel capsules, which; During the treatment period (24 weeks after enrollment), Subjects should take four (4) capsules (Ingested, Space Occupying hydrogel capsules or placebo) with water every day 10~20 minutes before lunch and dinner, and drink at least 500ml of water.	Device: Ingested, Space Occupying hydrogel capsules; During the treatment period (24 weeks after enrollment), Subjects should take four (4) capsules (Ingested, Space Occupying hydrogel capsules or placebo) with water every day 10~20 minutes before lunch and dinner, and drink at least 500ml of water
Placebo Comparator: Subjects in the Placebo group will be treated with placebo of the control medical device.; During the treatment period (24 weeks after enrollment), Subjects should take four (4) capsules (Ingested, Space Occupying hydrogel capsules or placebo) with water every day 10~20 minutes before lunch and dinner, and drink at least 500ml of water.	Device: placebo; During the treatment period (24 weeks after enrollment), Subjects should take four (4) capsules (Ingested, Space Occupying hydrogel capsules or placebo) with water every day 10~20 minutes before lunch and dinner, and drink at least 500ml of water

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight loss percentage from baseline at Week 24	Calculation formula:Weight loss percentage from baseline = (weight at Week 24 after enrollment of subject - baseline weight) / baseline weight×100%	24 weeks
Response rate of weight loss at week 24 after enrollment	Calculation formula:Weight loss response rate = Number of subjects with ≥5% weight loss percentage from baseline/total number of subjects ×100%.	24 weeks

Collaborators and Investigators

• Sponsor: IMEIK Technology Development Co., Ltd.
• Investigators: Principal Investigator: Peng Li, M.D., Beijing Friendship Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): July 31, 2024
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: July 19, 2024
• First Submitted That Met QC Criteria: July 29, 2024
• First Posted (Actual): July 31, 2024

Study Record Updates

• Last Update Posted (Actual): July 31, 2024
• Last Update Submitted That Met QC Criteria: July 29, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Obesity, Morbid
• Other Study ID Numbers: IMK-2023-NK001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No