Recruiting soon

Puerarin for Obesity and Metabolic Regulation

What is being tested

Puerarin

+ Placebo

Drug

Who is being recruted

Body Weight+6

+ Metabolic Diseases

+ Nutrition Disorders

From 18 to 60 Years

+24 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Placebo-ControlledPhase 2

Interventional

Study Start: August 2025

See protocol details

Summary

Principal SponsorRuijin Hospital

Study ContactJiqiu Wang, PhD, Principal Investigator

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: August 1, 2025

Actual date on which the first participant was enrolled.

This study is designed to test the effectiveness of a substance called puerarin in helping people with obesity manage their weight and improve their metabolism. The main focus is on adults with a Body Mass Index (BMI) of 30 or higher, which classifies them as obese. The research aims to see if puerarin can significantly reduce body weight and affect how the body processes fats after meals. Other aspects being looked into include changes in blood sugar levels over time and how the body uses energy at rest. This study may provide new insights into managing obesity and its related health issues. Participants will be split into two groups by chance. One group will receive a daily dose of puerarin injected orally in a saline solution, while the other group will receive just the saline solution, both without knowing which one they are getting. This will take place over six months. Throughout the study, doctors will check weight, waist size, and fat levels in the blood, as well as ensure safety by monitoring any side effects and other health indicators. These checks will happen at the start and then again after one, three, and six months. This helps in understanding the benefits and any risks associated with puerarin for treating obesity.

Official TitleRandomized Controlled Trial of Puerarin for Obesity Treatment

NCT06968208

Principal SponsorRuijin Hospital

Study ContactJiqiu Wang, PhD, Principal Investigator

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

80 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 60 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Body WeightMetabolic DiseasesNutrition DisordersNutritional and Metabolic DiseasesObesitySigns and SymptomsPathological Conditions, Signs and SymptomsOvernutritionOverweight

Criteria

6 inclusion criteria required to participate

Stable weight (<3% fluctuation) and lifestyle for ≥1 month prior to screening.

Aged 18-60 years (inclusive), any gender.

Obesity (BMI ≥30.0 kg/m²).

With or without obesity-related metabolic comorbidities (e.g., type 2 diabetes, hypertension, dyslipidemia, hyperuricemia).

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18 exclusion criteria prevent from participating

Secondary causes of obesity (e.g., monogenic obesity, Cushing's syndrome, drug-induced obesity).

History of common nutrient allergies (e.g., gluten, milk, eggs, plant-derived proteins).

Use of weight-control medications (e.g., metformin, GLP-1 receptor agonists, orlistat), corticosteroids (oral/IV/IM/non-oral systemic/intra-articular), or metabolic-interfering drugs/supplements within 3 months prior to screening or during the trial.

Use of traditional Chinese medicines or herbal products for weight management within 3 months prior to screening or during the trial.

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental

1. Diet Stabilization (Days 0-3): Standardized high-fat isocaloric diet (25% carbs, 58% fat, 17% protein) to normalize baseline metabolic status. 2. Intervention Period (6 months): Participants will receive oral administration of 75 mg puerarin dissolved in 0.9% sodium chloride solution, taken 30 minutes before lunch

Group II

Placebo

1. Diet Stabilization (Days 0-3): Standardized high-fat isocaloric diet (25% carbs, 58% fat, 17% protein) to normalize baseline metabolic status. 2. Intervention Period (6 months): Participants will receive oral administration of one matching blank 0.9% sodium chloride solution, taken 30 minutes before lunch. Blank injections are identical in appearance, taste, and packaging to the active puerarin injections but contain no active ingredients.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, ChinaOpen Ruijin Hospital, Shanghai Jiaotong University School of Medicine in Google Maps

Recruiting soonOne Study Center