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NCT07452757
To Evaluate Efficacy and Safety of Proprietary Healthy Diet Combinations for Weight Management in Overweight Volunteers
NA trial testing Arm II in Overweight (BMI > 25) in 140 participants. Completed in 13 May 2024.
13 May 2024
Quick facts
| Lead sponsor | Bioagile Therapeutics Pvt. Ltd. |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 140 |
| Start date | 15 November 2023 |
| Primary completion | 13 May 2024 |
| Estimated completion | 13 May 2024 |
| Sites | 1 location across India |
Drugs / interventions tested
- Arm II
- Arm III
- Arm IV
Conditions studied
- Overweight (BMI > 25) — all drugs for Overweight (BMI > 25) →
Sponsor
Bioagile Therapeutics Pvt. Ltd. — full company profile →
Who can join
Adults 20 to 45, any sex, with Overweight (BMI > 25). Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT07452757
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Bioagile Therapeutics Pvt. Ltd. trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07452757 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Bioagile Therapeutics Pvt. Ltd.
- Last refreshed: 12 March 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07452757.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing