Summary
Metformin Hydrochloride has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Obesity would be drug repurposing rather than first-in-human development. This does not mean it is approved for Obesity. ClinicalTrials.gov lists 8 registered trials linking Metformin Hydrochloride to Obesity: 1 is currently recruiting; 2 are active or not yet recruiting; 3 have completed; 2 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT06860841). The largest enrolment is 600 participants (NCT00541567). Registration activity spans 2008 to 2026. The literature layer holds 5 publications for this pair: 5 clinical trial publications. Publication years run from 2010 to 2020. These are primary trial reports rather than syntheses, so results have not yet been pooled or graded independently.
The RepurpOS disease-intelligence file for Obesity ranks 368 candidate therapeutics from Open Targets, ChEMBL, DGIdb and PubMed; only a minority carry direct clinical evidence, and this page covers one of those. Spontaneous remission context recorded for the condition: Sustained weight loss of >5% without intervention: ~5-10% at 2 years; weight regain almost universal after behavioural intervention alone (95% return to within 5% of starting weight at 5 years on lifestyle alone).
Evidence table
| Evidence tier | A · Strong |
|---|---|
| Evidence score | 54.5 (trials 24.5, literature 10.0, tier 15, approved bonus 5.0) |
| Registered trials | 8 total: 1 recruiting, 2 active / not yet recruiting, 3 completed, 2 other |
| Linked publications | 5 (5 clinical trial publications) |
| Agent type | Drug (Small molecule) |
| Development stage (any indication) | Approved |
| Mechanism / class | inhibitor |
| Data sources | DGIdb |
| Linked via biomarker / target | COXFA4L2 |
How the evidence score is calculated
- Each registered trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5). The trial component is capped at 30.
- Each literature item scores by design (Cochrane review 5, meta-analysis 4, systematic review 3, RCT 3, clinical trial publication 2, curated reference 1.5, other PubMed record 1). The literature component is capped at 30.
- The existing evidence tier adds 15 (A / Strong), 10 (B / Moderate), 5 (C / Preliminary) or 0 (D / Anecdotal).
- Agents approved for any indication (max clinical phase 4) add 5, because an approved agent has an established safety profile that lowers the barrier to repurposing trials.
- The score ranks what has been studied, not what works. It does not read effect sizes or directions of effect.
Registered clinical trials
| NCT ID | Title | Status | Phase | Enrolment |
|---|---|---|---|---|
| NCT06860841 | Effects of D-Chiro-Inositol Combined with Metformin on Insulin Resistance in People with Overweight or Obesity and T2DM 2025 | active, not recruiting | Phase 4 | 16 |
| NCT01234649 | Combined Liraglutide and Metformin Therapy in Women With Previous Gestational Diabetes Mellitus (GDM) 2011 | completed | Phase 3 | 153 |
| NCT02635386 | EQW, DAPA, EQW/DAPA, DAPA/MET ER and PHEN/TPM ER in Obese Women With PolycysticOvary Syndrome (PCOS) 2016 | completed | Phase 3 | 119 |
| NCT06995339 | Comparative Clinical and Biochemical Study Evaluating the Effectiveness of Metformin Versus Febuxostat on Gouty Obese Non-Diabetic Patients 2025 | recruiting | Phase 2 | 60 |
| NCT07502001 | Influence of HDM1005 on Gastric Emptying and Pharmacokinetics of Metformin, Atorvastatin, Warfarin, and Digoxin 2026 | not yet recruiting | Phase 1 | 42 |
| NCT02798172 | The Effect of Alogliptin on Pulmonary Function in Obese Patients With Type 2 Diabetes Inadequately Controlled by Metformin Monotherapy 2014 | completed | Not applicable | 81 |
| NCT06059287 | The Effect of Henagliflozin and Metformin on Myocardial Tissue-level Characteristics 2023 | status unknown | Not applicable | 64 |
| NCT00541567 | BMS-646256 in Obese and Overweight Type 2 Diabetics 2008 | withdrawn | PHASE2, PHASE3 | 600 |
Published literature
- Clinical trial publication No effect of a low dose of metformin on the lipid profile, body mass index and weight gain in pregnant women with obesity: A randomized trialDienstmann G, Nascimento IBD, Sales WB et al. · Obesity research & clinical practice · 2020 · PMID 33008770
- Clinical trial publication Effects of SLC22A1 Polymorphisms on Metformin-Induced Reductions in Adiposity and Metformin Pharmacokinetics in Obese Children With Insulin ResistanceSam WJ, Roza O, Hon YY et al. · Journal of clinical pharmacology · 2017 · PMID 27407018
- Clinical trial publication Effect of metformin on the level of anti-Mullerian hormone in therapy of polycystic ovary syndrome in obese womenGrigoryan O, Absatarova J, Andreeva E et al. · Minerva ginecologica · 2014 · PMID 24569407
- Clinical trial publication Effects of metformin hydrochloride on blood glucose and insulin responses to oral dextrose in horsesRendle DI, Rutledge F, Hughes KJ et al. · Equine veterinary journal · 2013 · PMID 23600690
- Clinical trial publication Metformin extended release treatment of adolescent obesity: a 48-week randomized, double-blind, placebo-controlled trial with 48-week follow-upWilson DM, Abrams SH, Aye T et al. · Archives of pediatrics & adolescent medicine · 2010 · PMID 20124139
Mechanism and notes
Recorded mechanism or class: inhibitor.
OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in DGIdb, in this case via the biomarker or target COXFA4L2. The tier describes how well the drug-disease link is documented, not how well the drug works.
Frequently asked questions
Is Metformin Hydrochloride approved for Obesity?
Metformin Hydrochloride has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Obesity would be drug repurposing rather than first-in-human development. This does not mean it is approved for Obesity. Approval status for the specific indication should always be confirmed with the relevant regulator and prescribing information.
Is Metformin Hydrochloride in clinical trials for Obesity?
ClinicalTrials.gov lists 8 registered trials linking Metformin Hydrochloride to Obesity: 1 is currently recruiting; 2 are active or not yet recruiting; 3 have completed; 2 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT06860841). The largest enrolment is 600 participants (NCT00541567). Registration activity spans 2008 to 2026.
What does the evidence show for Metformin Hydrochloride in Obesity?
Metformin Hydrochloride has 3 completed trials and 5 linked publications for Obesity. Completed trials may or may not have posted results; follow the NCT links to check. OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in DGIdb, in this case via the biomarker or target COXFA4L2. The tier describes how well the drug-disease link is documented, not how well the drug works.
Cite this page
Data: ClinicalTrials.gov, PubMed, Open Targets, ChEMBL, DGIdb and the OSMF therapeutic agent database. Last updated 2026-07-05. Page built 2026-10-07.