Metabolic DiseasesPhase 2NCT06968208
The Efficacy and Safety of Puerarin in Obesity Treatment
A Phase 2 study testing Puerarin in people with Metabolic Diseases and Obesity/Therapy, run by Ruijin Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Metabolic Diseases, Obesity/Therapy
- What is being tested?
- Puerarin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2025to 31 Dec 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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).
- Gastrointestinal disorders affecting absorption (e.g., IBD, active ulcers, severe diarrhea/constipation).
- Participation in other clinical trials within 3 months prior to screening.
- Any condition deemed unsuitable by investigators.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200000
About this study
Official title: Randomized Controlled Trial of Puerarin for Obesity Treatment
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
- Being tested
- Puerarin, Placebo
- Keywords
- Puerarin, Intestinal Lipid Absorption, Dorsal Motor Nucleus of Vagus (DMV)
- Medical subject headings
- Metabolic Diseases, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PuerarinDrug
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).
PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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®).
Measured: 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.
Measured: Measurements will be performed at each timepoint (baseline, 1, 3, and 6 months post-intervention) and twice a day
Fecal Lipids
Measured: 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
The blood samples will be collected after overnight fasting and 2 hours after meals.
Measured: Measurements will be performed at each timepoint (baseline, 1, 3, and 6 months post-intervention) and twice a day
Basal Metabolic Rate
Basal metabolic rate will be measured via indirect calorimetry using a validated metabolic cart under strictly standardized conditions: participants in a fasting state (≥12 hours overnight), resting supine in a thermoneutral environment (22-24°C), with 30 minutes of pre-measurement rest and avoidance of caffeine or vigorous activity for 24 hours prior.
Measured: Measurements will be performed in quadruplicate at each timepoint (baseline, 1, 3, and 6 months post-intervention), with the mean value recorded.
Gut Hormones
Like ghrelin, cholecystokinin (CCK), Glucagon-like peptide-1 (GLP-1), Peptide YY (PYY)
Measured: Measurements will be performed in quadruplicate at each timepoint (baseline, 1, 3, and 6 months post-intervention), with the mean value recorded.
Insulin level
The blood samples will be collected after overnight fasting(>8 hors).
Measured: 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
Measured: Measurements will be performed in quadruplicate at each timepoint (baseline, 1, 3, and 6 months post-intervention).
C-Peptide
The blood samples will be collected after overnight fasting(>8 hors).
Measured: Measurements will be performed in quadruplicate at each timepoint (baseline, 1, 3, and 6 months post-intervention), with the mean value recorded.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2025
- Study start1 Aug 2025 (estimated)
- Primary completion31 Jan 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic DiseasesStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06968208
- Sponsor's protocol ID
- Ruijin2025-177
- Status last verified
- Mar 2025
- First submitted
- 5 May 2025
- Last updated
- 21 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Puerarin for Obesity Treatment
- ClinicalTrials.gov ID
- NCT06968208
- Acronym / sponsor ID
- Ruijin2025-177
- Conditions
- Metabolic Diseases, Obesity/Therapy
- Keywords
- Puerarin, Intestinal Lipid Absorption, Dorsal Motor Nucleus of Vagus (DMV)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 1 Aug 2025 (estimated)
- Primary completion
- 31 Jan 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 13 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Puerarin Group | Experimental | Drug: Puerarin1. 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 |
| Placebo Group | Placebo comparator | Drug: Placebo1. 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Puerarin75 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). | Drug | Puerarin Group |
| Placebo0.9% 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. | Drug | Placebo Group |
Primary outcome
Body weight
Time frame: Measurements will be performed in quadruplicate at each timepoint (baseline, 1, 3, and 6 months post-intervention), with the mean value recorded.
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).
Body Fat Percentage
Time frame: 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 will be quantified via bioelectrical impedance analysis (BIA, InBody 770®).
Serum Lipid Profile (Total Cholesterol [TC], Triglycerides [TG])
Time frame: Measurements will be performed at each timepoint (baseline, 1, 3, and 6 months post-intervention) and twice a day
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.
Fecal Lipids
Time frame: Measurements will be performed in quadruplicate at each timepoint (baseline, 1, 3, and 6 months post-intervention), with the mean value recorded.
6 secondary outcomes
Blood Glucose
Time frame: Measurements will be performed at each timepoint (baseline, 1, 3, and 6 months post-intervention) and twice a day
Basal Metabolic Rate
Time frame: Measurements will be performed in quadruplicate at each timepoint (baseline, 1, 3, and 6 months post-intervention), with the mean value recorded.
Gut Hormones
Time frame: Measurements will be performed in quadruplicate at each timepoint (baseline, 1, 3, and 6 months post-intervention), with the mean value recorded.
Insulin level
Time frame: 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
Time frame: Measurements will be performed in quadruplicate at each timepoint (baseline, 1, 3, and 6 months post-intervention).
C-Peptide
Time frame: Measurements will be performed in quadruplicate at each timepoint (baseline, 1, 3, and 6 months post-intervention), with the mean value recorded.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Puerarin in people with Metabolic Diseases and Obesity/Therapy, run by Ruijin Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jiqiu Wang, PhD, Principal Investigator (+86-153-0048-3751, wangjg@shsmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body weight (time frame: Measurements will be performed in quadruplicate at each timepoint (baseline, 1, 3, and 6 months post-intervention), with the mean value recorded.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2025.