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

NCT06530017 | Not Yet Recruiting

• 1 other identifier: IMK-2023-NK001
• Study Type: interventional
• Target: 440
• Locations: 1 country
• Sites: 10

Brief Summary

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

Conditions

Simple Obesity

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Subjects in the Study group will be treated with Ingested, Space Occupying hydrogel capsules, which

EXPERIMENTAL

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

Subjects in the Placebo group will be treated with placebo of the control medical device.

PLACEBO COMPARATOR

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

Interventions

Ingested, Space Occupying hydrogel capsules 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

Subjects in the Study group will be treated with Ingested, Space Occupying hydrogel capsules, which

placebo 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

Subjects in the Placebo group will be treated with placebo of the control medical device.

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• IMEIK Technology Development Co., Ltd.: lead

Study Sites (10)

Beijing Friendship Hospital,Capital Medical University

Beijing, Beijing Municipality, 100032, China

Location

Peking University Shougang Hospital

Beijing, Beijing Municipality, 100043, China

Location

Beijing Shijitan Hospital, Capital Medical University

Beijing, Beijing Municipality, 100071, China

Location

The First Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050023, China

Location

The Third XiangYa Hospital of Central South University

Changsha, Hunan, 410013, China

Location

The First Affiliated Hospital of China Medical University

Shenyang, Liaoning, 110001, China

Location

Shengjing Hospital Of China Medical University

Shenyang, Liaoning, 110004, China

Location

The First Affiliated Hospital of Henan University of Science & Technology

Luoyang, Luoyang, 471003, China

Location

QILU Hospital Of Shandong University

Jinan, Shandong, 250012, China

Location

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, 300070, China

Location

Study Officials

• Peng Li, M.D.

  Beijing Friendship Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wei Li

CONTACT

13520464757; liwei@imeik.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2024
• First Posted: July 31, 2024
• Study Start: July 31, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: July 31, 2024

Record last verified: 2024-07

Locations

CN (10)