The Efficacy and Safety of Puerarin in Obesity Treatment

NCT ID: NCT06968208

Last Updated: 2025-05-21

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-01
• Study Completion Date: 2029-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Puerarin Group

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 Type: EXPERIMENTAL

Puerarin

Intervention Type: 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).

Placebo Group

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: 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.

Interventions

Puerarin

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).

Intervention Type: DRUG

Placebo

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

2. Obesity (BMI ≥30.0 kg/m²).

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

4. No prior use of weight-control, glucose-lowering, or lipid-modifying medications.

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

6. Fully informed of trial objectives, procedures, risks, and benefits; voluntarily signed informed consent form.

Exclusion Criteria

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

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

3. 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.

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

5. History of psychiatric disorders, epilepsy, antidepressant use, or ongoing antiepileptic therapy.

6. Pregnancy, lactation, or plans for pregnancy within 6 months post-trial.

7. Active infectious diseases (e.g., HBV, HCV, tuberculosis, syphilis, HIV).

8. Severe infections, severe anemia (Hb <8 g/dL), or neutropenia (ANC <1.5×10⁹/L).

9. Gastrointestinal surgery within 1 year (excluding appendectomy/hernia repair) or major non-GI surgery within 6 months.

10. Active substance/alcohol abuse.

11. Known hypersensitivity to trial drug components or history of severe drug allergies.

12. Severe cardiac disorders (e.g., congenital/rheumatic heart disease, cardiomyopathy [NYHA ≥III], coronary stenting).

13. Hyperthyroidism or hypothyroidism.

14. History of malignancies (treated/untreated), regardless of recurrence status.

15. Hepatic/renal dysfunction: ALT/AST ≥2.5×ULN, serum creatinine >ULN, or eGFR <60 mL/min/1.73m² (MDRD formula).

16. Gastrointestinal disorders affecting absorption (e.g., IBD, active ulcers, severe diarrhea/constipation).

17. Participation in other clinical trials within 3 months prior to screening.

18. Any condition deemed unsuitable by investigators.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ruijin Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China

Countries

China

Central Contacts

Jiqiu Wang, PhD, Principal Investigator

Role: CONTACT

wangjg@shsmu.edu.cn

+86-153-0048-3751

Other Identifiers

Ruijin2025-177

Identifier Type: -

Identifier Source: org_study_id