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Clinical Trial to Evaluate the Ingested, Space Occupying Hydrogel Capsules for Simple Obesity Treatment | Clinical Trials | Clareo Health

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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

NCT06530017•IMEIK Technology Development Co., Ltd.

View on ClinicalTrials.gov

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

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

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.
+9 more criteria

Locations (10)

Beijing Friendship Hospital,Capital Medical University

Beijing, Beijing Municipality, China

Peking University Shougang Hospital

Beijing, Beijing Municipality, China

Beijing Shijitan Hospital, Capital Medical University

Beijing, Beijing Municipality, China

The First Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

The Third XiangYa Hospital of Central South University

Changsha, Hunan, China

The First Affiliated Hospital of China Medical University

Shenyang, Liaoning, China

Shengjing Hospital Of China Medical University

Shenyang, Liaoning, China

The First Affiliated Hospital of Henan University of Science & Technology

Luoyang, Luoyang, China

QILU Hospital Of Shandong University

Jinan, Shandong, China

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, China

Key Dates

Start Date

July 31, 2024

Primary Completion Date

December 31, 2025

Completion Date

June 30, 2026

Last Updated

July 31, 2024

Enrollment

440

ESTIMATED participants

Conditions

Simple Obesity

Interventions

Ingested, Space Occupying hydrogel capsules

DEVICE

placebo

DEVICE

Contacts

Wei Li

CONTACT

13520464757 liwei@imeik.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 31, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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