The Efficacy and Safety of Puerarin in Obesity Treatment

NCT06968208 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: Ruijin2025-177
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized controlled trial aims to evaluate the therapeutic efficacy of puerarin intervention in weight management and metabolic regulation among obese populations. The study will systematically address two primary endpoints: 1) The capacity of puerarin to induce clinically significant body weight reduction in individuals with BMI ≥30 kg/m²; 2) Its modulatory effects on postprandial lipid metabolism as measured by serum lipids and quantitative fecal lipid excretion analysis. Secondary outcomes focus on puerarin's pleiotropic effects, including continuous glucose monitoring-derived glycemic parameters and indirect calorimetry-assessed resting metabolic rate. Secondary exploratory objectives include investigating puerarin's potential mechanisms of action through continuous glucose monitoring and indirect calorimetry measurements to assess glycemic variability and resting energy expenditure, respectively. Participants will be randomized into two parallel groups: the intervention group receiving daily oral puerarin injection (75 mg/day, dissolved in 100 mL of 0.9% sodium chloride solution) and the control group receiving matched blank 100 mL of 0.9% sodium chloride solution, both administered double-blind for 6 consecutive months. Primary efficacy endpoints (body weight, waist circumference, lipid profile) and safety monitoring (adverse events, hematological/ biochemical parameters) will be assessed at baseline, 1, 3, and 6 months post-intervention.

Conditions

Metabolic Diseases; Obesity/Therapy

Keywords

Puerarin; Intestinal Lipid Absorption; Dorsal Motor Nucleus of Vagus (DMV)

Outcome Measures

Primary Outcomes (4)

• Body weight

  Body weight will be measured to the nearest 0.1 kg using a calibrated digital scale under standardized conditions: participants in lightweight clothing (hospital gown), barefoot, and after an overnight fast (≥8 hours).

  Measurements will be performed in quadruplicate at each timepoint (baseline, 1, 3, and 6 months post-intervention), with the mean value recorded.

• Body Fat Percentage

  Body fat percentage will be quantified via bioelectrical impedance analysis (BIA, InBody 770®).

  Measurements will be performed in quadruplicate at each timepoint (baseline, 1, 3, and 6 months post-intervention), with the mean value recorded.

• Serum Lipid Profile (Total Cholesterol [TC], Triglycerides [TG])

  Total Cholesterol (TC): Measured via cholesterol oxidase-peroxidase method, traceable to CDC reference standards. Triglycerides (TG): Quantified using glycerol-3-phosphate oxidase method with correction for free glycerol. The blood samples will be collected before and 2 hours after meals.

  Measurements will be performed at each timepoint (baseline, 1, 3, and 6 months post-intervention) and twice a day

• Fecal Lipids

  Measurements will be performed in quadruplicate at each timepoint (baseline, 1, 3, and 6 months post-intervention), with the mean value recorded.

Secondary Outcomes (6)

• Blood Glucose

  Measurements will be performed at each timepoint (baseline, 1, 3, and 6 months post-intervention) and twice a day

• Basal Metabolic Rate

  Measurements will be performed in quadruplicate at each timepoint (baseline, 1, 3, and 6 months post-intervention), with the mean value recorded.

• Gut Hormones

  Measurements will be performed in quadruplicate at each timepoint (baseline, 1, 3, and 6 months post-intervention), with the mean value recorded.

• Insulin level

  Measurements will be performed in quadruplicate at each timepoint (baseline, 1, 3, and 6 months post-intervention), with the mean value recorded.

• Gut Microbiome Metagenomics

  Measurements will be performed in quadruplicate at each timepoint (baseline, 1, 3, and 6 months post-intervention).

Study Arms (2)

Puerarin Group

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

Drug: Puerarin

Placebo Group

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

Puerarin DRUG

75 mg of puerarin injection, dissolved in 0.9% sodium chloride solution. The puerarin injection is manufactured under Good Manufacturing Practice (GMP) conditions by \[Harbin Medisan Pharmaceutical Co., Ltd.\], with identical appearance, size, and packaging to the blank 0.9% sodium chloride solution to ensure blinding. Stability testing confirms integrity under standard storage conditions (25°C, 60% RH).

Puerarin Group

Placebo DRUG

0.9% sodium chloride solution formulated to match the appearance, size, and taste of the active puerarin solution, with no other active pharmaceutical ingredients. 0.9% sodium chloride solution is manufactured under identical Good Manufacturing Practiceconditions by \[Shijiazhuang No.4 Pharmaceutical Co., Ltd.\] and changed to the same batch processes and packaging as the intervention group. Stability testing confirms equivalent integrity under standard storage conditions (25°C, 60% RH). Blinding is ensured through indistinguishable outer packing characteristics and labeling.

Placebo Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).
• No prior use of weight-control, glucose-lowering, or lipid-modifying medications.
• Stable weight (\<3% fluctuation) and lifestyle for ≥1 month prior to screening.
• Fully informed of trial objectives, procedures, risks, and benefits; voluntarily signed informed consent form.

You may not qualify if:

• 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.
• History of psychiatric disorders, epilepsy, antidepressant use, or ongoing antiepileptic therapy.
• Pregnancy, lactation, or plans for pregnancy within 6 months post-trial.
• Active infectious diseases (e.g., HBV, HCV, tuberculosis, syphilis, HIV).
• Severe infections, severe anemia (Hb \<8 g/dL), or neutropenia (ANC \<1.5×10⁹/L).
• Gastrointestinal surgery within 1 year (excluding appendectomy/hernia repair) or major non-GI surgery within 6 months.
• Active substance/alcohol abuse.
• Known hypersensitivity to trial drug components or history of severe drug allergies.
• Severe cardiac disorders (e.g., congenital/rheumatic heart disease, cardiomyopathy \[NYHA ≥III\], coronary stenting).
• Hyperthyroidism or hypothyroidism.
• History of malignancies (treated/untreated), regardless of recurrence status.
• Hepatic/renal dysfunction: ALT/AST ≥2.5×ULN, serum creatinine \>ULN, or eGFR \<60 mL/min/1.73m² (MDRD formula).

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200000, China

Location

MeSH Terms

Conditions

Metabolic Diseases; Obesity

Interventions

puerarin

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Jiqiu Wang, PhD, Principal Investigator

CONTACT

+86-153-0048-3751; wangjg@shsmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study utilizes a randomized, double-blind, placebo-controlled, parallel-group design. Participants will be allocated 1:1 to either the intervention group receiving daily oral puerarin (75 mg/day, dissolved in 100 mL of 0.9% sodium chloride solution) or the control group receiving identically matched blank 100 mL of 0.9% sodium chloride solution for 6 consecutive months. Randomization will be stratified by baseline body mass index (BMI) and performed via a centralized computer-generated sequence with allocation concealment. Both participants and investigators will remain blinded to treatment assignment throughout the trial. Primary efficacy endpoints (body weight reduction, waist circumference, and lipid profile improvement) and safety outcomes (adverse events, hematological/biochemical parameters) will be assessed at baseline, 1, 3, and 6 months post-randomization. The study adheres to CONSORT guidelines for clinical trial reporting.

Study Record Dates

• First Submitted: May 5, 2025
• First Posted: May 13, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): January 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: May 21, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)