Overweight (BMI > 25)NCT07452757
To Evaluate Efficacy and Safety of Proprietary Healthy Diet Combinations for Weight Management in Overweight Volunteers
A study testing Arm II, Arm III and Arm IV in people with Overweight (BMI > 25), run by Bioagile Therapeutics Pvt. Ltd. at 1 site in India.
Trial summary
This is an open-label, four-arm, randomized, controlled clinical study designed to evaluate the efficacy and safety of a structured Weight Management Program (WMP) in overweight and obese adults with a body mass index (BMI) ≥ 23 kg/m² (Asian Indian ethnicity cut-off). Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight (BMI > 25)
- What is being tested?
- Arm II, Arm III and Arm IV
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteIndia
- Study dates
- 15 Nov 2023to 13 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 20 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- - Male and female subjects age between 20 to 45 years
- Non-pregnant and non-lactating
- Body Mass Index (kg/m2)- ≥ 23 (considered overweight/obese as per the ethnicity cut off values for Asian Indians)
- Following stable eating habits
- Not on any medication that can affect Lipid profile, body composition or weight
- Nonalcoholic and non- smoker
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- Subjects who are willing to sign the informed consent and comply with study requirement of meal replacements strictly
- Women in the reproductive age group- should be agreeing to follow standard contraceptive measures
- Individuals who are seriously motivated to lose weight and willing to be part of any one of the interventions where Protein drink with buttermilk, skimmed milk or water OR 1 Meal replacement OR 2 Meal replacement would be given.
Who cannot join
- - On medication/ HRT (Hormone Replacement Therapy)
- Suffering from endocrine hypothalamic- pituitary disease, women with PCOS, adrenal disorder, hypothyroidism,
- Subjects with Diabetes type 1 or 2 to be excluded
- Women in the reproductive age group not willing to use standard contraceptive measures.
- Other conditions like CKD, stones, liver dysfunction (with elevated enzyme levels), history of cancer, eating disorders, chronic gastrointestinal disorders (IBD or celiac), metabolic disorders like hypertension, CVDs- that might impair the outcomes
- Malignancy which is currently active or in remission for less than five years after last treatment
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- Unstable weight (± 5 % fluctuation in their body weight for past 8-weeks at study entry)
- Have undergone gastroplasty or weight reducing surgery
- Subjects who have participated in another clinical study within the past 30 days prior to screening or are likely to simultaneously participate in another clinical study.
- Practicing any structured commercial weight management program/ intermittent fasting or any diet regime in the last 30 days prior to screening.
- Patients who are doubtful to comply with study procedures for mental, psychological or social reasons.
Trial locations and contacts
1 site in 1 country.
India1 site
Sapthagiri Institute of Medical Sciences & Research Centre
Bangalore, Karnataka, 560090
About this study
Official title: To Evaluate the Efficacy and Safety of Weight Management Program in Overweight/Obese Individuals: A 4 Arm Open Label Randomized Controlled Clinical Study
This is an open-label, four-arm, randomized, controlled clinical study designed to evaluate the efficacy and safety of a structured Weight Management Program (WMP) in overweight and obese adults with a body mass index (BMI) ≥ 23 kg/m² (Asian Indian ethnicity cut-off). A total of 140 subjects will be enrolled and randomized equally into four arms: one control arm and three intervention arms with varying levels of nutritional intervention.
The Weight Management Program comprises three sequential phases: a pre-engagement gut-reset phase (10 days), an intensive intervention phase (30 days), and a maintenance phase (60 days). The intervention arms will receive combinations of meal replacements, protein supplements, fiber supplements, probiotics, and multivitamin-multimineral supplements, along with nutritional and behavioral counseling, calorie-deficit diet plans, and prescribed physical activity. The control arm will follow a free-living lifestyle without intervention.
Read more
The primary efficacy outcome is the proportion of subjects demonstrating a reduction in body weight and/or BMI from baseline to the end of the intensive phase. Secondary outcomes include changes in body weight and BMI at the end of the maintenance phase, maintenance of weight loss, changes in body composition, waist circumference, waist-hip ratio, lipid profile, metabolic parameters, physical activity, quality of life, and safety outcomes including adverse events.
The study aims to generate evidence on the effectiveness and safety of a holistic, lifestyle-based weight management program incorporating nutritional supplementation, dietary modification, physical activity, and behavioral support in overweight and obese individuals.
- Conditions
- Overweight (BMI > 25)
- Being tested
- Arm II, Arm III, Arm IV
- Keywords
- Weight management programme
- Medical subject headings
- Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arm IIDietary supplement
- Investigational Product Morning- PRP-02 (1 scoop) + AND-16 Afternoon- PRP-02 (1 scoop) Night-PRP-02 (1 scoop) + FBR-18 (1 scoop) +PRO-19 II. Nutritional+ Behavioral counselling (Audio clips will be shared) III. Calorie deficit Diet Plan IV. Physical exercise: Moderate exercise - 30-60-minute exercise 5 days a week or 150-300-minute exercise per week (Exercise: brisk walking, aerobic exercise, jogging, cycling etc)
Arm IIIDietary supplement
- Investigational Product - Replace breakfast with BDK-01+PRP-02 (2 scoops) Afternoon - as per diet plan Night- FBR- 18 (1 scoop) +PRO- 19 II. Nutritional + Behavioral counselling (Daily audio clips will be shared) III. Calorie deficit Diet Plan IV. Physical exercise: Moderate exercise - 30-60 minute exercise 5 days a week or 150 - 300 minute exercise per week (Exercise: brisk walking, aerobic exercise, jogging, cycling etc)
Arm IVDietary supplement
- Investigational Product Replace breakfast with BDK-01+PRP-02 (2 scoops) Afternoon-BDK-01+ Skimmed milk powder (Only during intensive phase, in maintenance phase switch to 1 meal replacement only) Night-FBR- 18+PRO- 19 II. Nutritional + Behavioral counselling (Daily audio clips will be shared) III. Calorie deficit Diet Plan IV. Physical exercise: Moderate exercise - 30-60 minute exercise 5 days a week or 150-300 minute exercise per week (Exercise: brisk walking, aerobic exercise, jogging, cycling etc)
| Study group | Role | What they receive |
|---|---|---|
| Arm I (Control group) | No intervention | Not described |
| Arm II (PRP-02 before all the meals) | Experimental | Not described Receives: Dietary Supplement: Arm II |
| Arm III (1 meal replacement) | Experimental | Not described Receives: Dietary Supplement: Arm III |
| Arm IV (2 Meal replacement) | Experimental | Not described Receives: Dietary Supplement: Arm IV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Body Weight
To assess the number and percentage of subjects demonstrating a reduction in body weight from baseline to the end of the intensive phase across intervention and control arms.
Measured: Baseline (Day 1) to end of intensive phase (Day 30)
Secondary outcomes (17)
Change in BMI During Maintenance Phase
To assess the number and percentage of subjects demonstrating a reduction in BMI from baseline to the end of the maintenance phase, and the proportion of subjects maintaining weight loss achieved during the intensive phase.
Measured: Baseline (Day 1) to end of study (Day 90)
Change in Body Fat Percentage
To evaluate the change in body fat percentage from baseline to end of study using a validated body composition analyzer, and to compare the mean change between study arms.
Measured: Baseline (Day 1) to end of study (Day 90)
Change in Waist Circumference
To assess the change in waist circumference from baseline to the end of the study and to compare the mean change between intervention and control arms.
Measured: Baseline (Day 1) to end of study (Day 90)
Change in Total Cholesterol
To evaluate the change in total cholesterol levels from baseline to the end of the study and to compare the mean change between intervention and control arms.
Measured: Baseline (Day 1) to end of study (Day 90)
Change in Quality of Life
Change from baseline in quality of life assessed using the World Health Organization Quality of Life - Brief Version (WHOQOL-BREF) questionnaire from baseline to the end of the study. The WHOQOL-BREF is a validated 26-item questionnaire that assesses four domains: physical health, psychological health, social relationships, and environment. Domain scores are transformed to a 0-100 scale, where higher scores indicate better quality of life.
Measured: Baseline (Day 1) to end of study (Day 90)
Incidence of Adverse Events
To assess the incidence, severity, and relationship of adverse events reported during the study period across all study arms.
Measured: From baseline (Day 1) to end of study (Day 90)
Change in Muscle Mass
To evaluate the change in muscle mass from baseline to end of study using a validated body composition analyzer, and to compare the mean change between study arms.
Measured: Baseline (Day 1) to End of Study (Day 90)
Change in Fat-Free Mass
To evaluate the change in fat-free mass from baseline to end of study using a validated body composition analyzer, and to compare the mean change between study arms.
Measured: Baseline (Day 1) to End of Study (Day 90)
Change in Visceral Fat Level
To evaluate the change in visceral fat level from baseline to end of study using a validated body composition analyzer, and to compare the mean change between study arms.
Measured: Baseline (Day 1) to End of Study (Day 90)
Change in Waist-to-Hip Ratio
To assess the change in waist-to-hip ratio from baseline to the end of the study and to compare the mean change between intervention and control arms.
Measured: Baseline (Day 1) to End of Study (Day 90)
Change in Skinfold Thickness
To assess the change in skinfold thickness from baseline to the end of the study and to compare the mean change between intervention and control arms.
Measured: Baseline (Day 1) to End of Study (Day 90)
Change in Triglycerides
To evaluate the change in triglyceride levels from baseline to the end of the study and to compare the mean change between intervention and control arms.
Measured: Baseline (Day 1) to End of Study (Day 90)
Change in High-Density Lipoprotein (HDL) Cholesterol
To evaluate the change in HDL cholesterol levels from baseline to the end of the study and to compare the mean change between intervention and control arms.
Measured: Baseline (Day 1) to End of Study (Day 90)
Change in Low-Density Lipoprotein (LDL) Cholesterol
To evaluate the change in LDL cholesterol levels from baseline to the end of the study and to compare the mean change between intervention and control arms.
Measured: Baseline (Day 1) to End of Study (Day 90)
Change in Fasting Blood Glucose
To evaluate the change in fasting blood glucose levels from baseline to the end of the study and to compare the mean change between intervention and control arms.
Measured: Baseline (Day 1) to End of Study (Day 90)
Change in Glycated Hemoglobin (HbA1c)
To evaluate the change in HbA1c levels from baseline to the end of the study and to compare the mean change between intervention and control arms.
Measured: Baseline (Day 1) to End of Study (Day 90)
Change in Serum Insulin
To evaluate the change in fasting serum insulin levels from baseline to the end of the study and to compare the mean change between intervention and control arms.
Measured: Baseline (Day 1) to End of Study (Day 90)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2026
- Study start15 Nov 2023
- Primary completion13 May 2024
- Study completion13 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight (BMI > 25)Studies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bioagile Therapeutics Pvt. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Divya Divya, Study director, BioAgile Therapeutics Private Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07452757
- Sponsor's protocol ID
- AMW/ CTP/WMP/07-2022
- Status last verified
- Jan 2026
- First submitted
- 30 Jan 2026
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Evaluate the Efficacy and Safety of Weight Management Program in Overweight/Obese Individuals: A 4 Arm Open Label Randomized Controlled Clinical Study
- ClinicalTrials.gov ID
- NCT07452757
- Acronym / sponsor ID
- AMW/ CTP/WMP/07-2022
- Conditions
- Overweight (BMI > 25)
- Keywords
- Weight management programme
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Bioagile Therapeutics Pvt. Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Nov 2023 (actual)
- Primary completion
- 13 May 2024 (actual)
- Study completion
- 13 May 2024 (actual)
- First posted
- 5 Mar 2026 (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 is an open-label, four-arm, randomized, controlled clinical study designed to evaluate the efficacy and safety of a structured Weight Management Program (WMP) in overweight and obese adults with a body mass index (BMI) ≥ 23 kg/m² (Asian Indian ethnicity cut-off). A total of 140 subjects will be enrolled and randomized equally into four arms: one control arm and three intervention arms with varying levels of nutritional intervention.
The Weight Management Program comprises three sequential phases: a pre-engagement gut-reset phase (10 days), an intensive intervention phase (30 days), and a maintenance phase (60 days). The intervention arms will receive combinations of meal replacements, protein supplements, fiber supplements, probiotics, and multivitamin-multimineral supplements, along with nutritional and behavioral counseling, calorie-deficit diet plans, and prescribed physical activity. The control arm will follow a free-living lifestyle without intervention.
The primary efficacy outcome is the proportion of subjects demonstrating a reduction in body weight and/or BMI from baseline to the end of the intensive phase. Secondary outcomes include changes in body weight and BMI at the end of the maintenance phase, maintenance of weight loss, changes in body composition, waist circumference, waist-hip ratio, lipid profile, metabolic parameters, physical activity, quality of life, and safety outcomes including adverse events.
The study aims to generate evidence on the effectiveness and safety of a holistic, lifestyle-based weight management program incorporating nutritional supplementation, dietary modification, physical activity, and behavioral support in overweight and obese individuals.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm I (Control group) | No intervention | – |
| Arm II (PRP-02 before all the meals) | Experimental | Dietary Supplement: Arm II |
| Arm III (1 meal replacement) | Experimental | Dietary Supplement: Arm III |
| Arm IV (2 Meal replacement) | Experimental | Dietary Supplement: Arm IV |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- - Male and female subjects age between 20 to 45 years
- Non-pregnant and non-lactating
- Body Mass Index (kg/m2)- ≥ 23 (considered overweight/obese as per the ethnicity cut off values for Asian Indians)
- Following stable eating habits
- Not on any medication that can affect Lipid profile, body composition or weight
Key exclusion criteria (11 listed)
- - On medication/ HRT (Hormone Replacement Therapy)
- Suffering from endocrine hypothalamic- pituitary disease, women with PCOS, adrenal disorder, hypothyroidism,
- Subjects with Diabetes type 1 or 2 to be excluded
- Women in the reproductive age group not willing to use standard contraceptive measures.
- Other conditions like CKD, stones, liver dysfunction (with elevated enzyme levels), history of cancer, eating disorders, chronic gastrointestinal disorders (IBD or celiac), metabolic disorders like hypertension, CVDs- that might impair the outcomes
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 |
|---|---|---|
| Arm III. Investigational Product Morning- PRP-02 (1 scoop) + AND-16 Afternoon- PRP-02 (1 scoop) Night-PRP-02 (1 scoop) + FBR-18 (1 scoop) +PRO-19 II. Nutritional+ Behavioral counselling (Audio clips will be shared) III. Calorie deficit Diet Plan IV. Physical exercise: Moderate exercise - 30-60-minute exercise 5 days a week or 150-300-minute exercise per week (Exercise: brisk walking, aerobic exercise, jogging, cycling etc) | Dietary supplement | Arm II (PRP-02 before all the meals) |
| Arm IIII. Investigational Product - Replace breakfast with BDK-01+PRP-02 (2 scoops) Afternoon - as per diet plan Night- FBR- 18 (1 scoop) +PRO- 19 II. Nutritional + Behavioral counselling (Daily audio clips will be shared) III. Calorie deficit Diet Plan IV. Physical exercise: Moderate exercise - 30-60 minute exercise 5 days a week or 150 - 300 minute exercise per week (Exercise: brisk walking, aerobic exercise, jogging, cycling etc) | Dietary supplement | Arm III (1 meal replacement) |
| Arm IVI. Investigational Product Replace breakfast with BDK-01+PRP-02 (2 scoops) Afternoon-BDK-01+ Skimmed milk powder (Only during intensive phase, in maintenance phase switch to 1 meal replacement only) Night-FBR- 18+PRO- 19 II. Nutritional + Behavioral counselling (Daily audio clips will be shared) III. Calorie deficit Diet Plan IV. Physical exercise: Moderate exercise - 30-60 minute exercise 5 days a week or 150-300 minute exercise per week (Exercise: brisk walking, aerobic exercise, jogging, cycling etc) | Dietary supplement | Arm IV (2 Meal replacement) |
Primary outcome
Change in Body Weight
Time frame: Baseline (Day 1) to end of intensive phase (Day 30)
To assess the number and percentage of subjects demonstrating a reduction in body weight from baseline to the end of the intensive phase across intervention and control arms.
17 secondary outcomes
Change in BMI During Maintenance Phase
Time frame: Baseline (Day 1) to end of study (Day 90)
Change in Body Fat Percentage
Time frame: Baseline (Day 1) to end of study (Day 90)
Change in Waist Circumference
Time frame: Baseline (Day 1) to end of study (Day 90)
Change in Total Cholesterol
Time frame: Baseline (Day 1) to end of study (Day 90)
Change in Quality of Life
Time frame: Baseline (Day 1) to end of study (Day 90)
Incidence of Adverse Events
Time frame: From baseline (Day 1) to end of study (Day 90)
Change in Muscle Mass
Time frame: Baseline (Day 1) to End of Study (Day 90)
Change in Fat-Free Mass
Time frame: Baseline (Day 1) to End of Study (Day 90)
Change in Visceral Fat Level
Time frame: Baseline (Day 1) to End of Study (Day 90)
Change in Waist-to-Hip Ratio
Time frame: Baseline (Day 1) to End of Study (Day 90)
Change in Skinfold Thickness
Time frame: Baseline (Day 1) to End of Study (Day 90)
Change in Triglycerides
Time frame: Baseline (Day 1) to End of Study (Day 90)
Change in High-Density Lipoprotein (HDL) Cholesterol
Time frame: Baseline (Day 1) to End of Study (Day 90)
Change in Low-Density Lipoprotein (LDL) Cholesterol
Time frame: Baseline (Day 1) to End of Study (Day 90)
Change in Fasting Blood Glucose
Time frame: Baseline (Day 1) to End of Study (Day 90)
Change in Glycated Hemoglobin (HbA1c)
Time frame: Baseline (Day 1) to End of Study (Day 90)
Change in Serum Insulin
Time frame: Baseline (Day 1) to End of Study (Day 90)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2026.
- 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. This study is not recruiting at the moment.
Divya Divya study director
BioAgile Therapeutics Private Limited
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arm II, Arm III and Arm IV in people with Overweight (BMI > 25), run by Bioagile Therapeutics Pvt. Ltd. at 1 site in India.
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 9 inclusion and 11 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: finished, as of the sponsor's last update on 12 Mar 2026. 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 India. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Body Weight (time frame: Baseline (Day 1) to end of intensive phase (Day 30)). 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 12 Mar 2026.