MetforminPhase 2AGE-MNCT06459310
Pilot Study on Evaluating the Geroprotective Effect of Metformin
A Phase 2 study testing Metformin Hydrochloride tablet in people with Metformin and Aging, run by Xuanwu Hospital, Beijing at 1 site in China.
Trial summary
The objective of this research is to assess the efficacy of oral metformin in mitigating the aging process in middle-aged and elderly males, to pinpoint sensitive indicators of human senescence, and to offer innovative frameworks and scientific insights for pharmaceutical interventions in aging. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- What is being tested?
- Metformin Hydrochloride tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 130 participants
- Where
- 1 siteChina
- Study dates
- 30 Jun 2024to 31 Jul 2028
- 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 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male
- Age 55-65; 18-28;
- Able to understand and execute instructions;
- After reading the consent form, be able to answer questions about the study and demonstrate understanding of the protocol;
- Be able to participate in regular follow-up visits.
Who cannot join
- Severe chronic or acute disease: cancer, clinically significant congestive heart failure, chronic obstructive pulmonary disease (COPD), previous or new-onset diabetes, inflammatory state, serum creatinine >1.5 mg/dl , active liver disease, History of metabolic acidosis, poorly controlled hypertension, epilepsy, recent (within 3 months) cardiovascular events (MI, PTCA, CABG, stroke), severe renal insufficiency, inflammatory bowel disease, persistent glucocorticoids Treatment; neurological diseases such as dementia, AD, PD, etc.; infectious diseases such as HIV, hepatitis, tuberculosis, etc.; severe autoimmune diseases;
- BMI<18.5 or BMI>30;
- Persistent alcohol or drug abuse;
- Treatment with drugs known to affect glucose metabolism (other diabetes drugs, systemic glucocorticoids, niacin);
- Hypersensitivity to metformin or any component of the preparation;
- Have taken metformin, low-dose aspirin, acarbose, vitamin C in the recent (3 months);
- Unable to provide informed consent;
- Other circumstances in which the researcher believes that the physical factors of the participants may adversely affect the research process or results.
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, 1 recruiting
- Recruiting
Xuanwu Hospital Capital Medical University
Beijing
Ming Yi, 13269087337, yiming1005@163.com
Liyun Zhao, 17801137417, zhaoliyun1992@163.com
About this study
Official title: A Phase II Exploratory Clinical Study Investigating the Geroprotective Effect of Metformin in Middle-aged and Elderly People
The objective of this research is to assess the efficacy of oral metformin in mitigating the aging process in middle-aged and elderly males, to pinpoint sensitive indicators of human senescence, and to offer innovative frameworks and scientific insights for pharmaceutical interventions in aging.
Read the detailed description
Subjects in both the metformin hydrochloride extended-release tablets treatment group and the placebo group received two tablets (500 mg each) once daily after dinner, continuing for a one-year period of drug intervention.
- Being tested
- Metformin Hydrochloride tablet, Placebo
- Keywords
- aging intervention, metformin, aging biomarker, multi-omics, middle-aged and elderly people, molecular clocks, biological age
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metformin Hydrochloride tabletDrug
Also called Metformin
Extended release oral tablets, 1000 mg/day, single dose
PlaceboDrug
Oral tablets, 1000 mg/day, single dose
| Study group | Role | What they receive |
|---|---|---|
| Metformin hydrochloride | Experimental | 1000 mg/day Metformin hydrochloride extended-release tablets Receives: Drug: Metformin Hydrochloride tablet |
| Placebo group | Placebo comparator | 1000 mg/day placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite the efficacy of metformin in intervening aging
- Metformin delay aging related sensitive indicators (2), such as SA*, ancient virus *.
- Metformin inhibits markers of inflammation in the body (4), such as C1 protein *, CRP, CXCL9, TNFa.
- Metformin improved immune cell-related indicators (10*), such as T1/T2/L gene expression.
- Metformin improves metabolism-related indexes (4), such as metabolic secretion factors APOX1* and APOX2*.
- Age-related indicators have been published (5), such as telomere length, DNA methylation age, hormone levels, etc.
Measured: Baseline - 12 month
Secondary outcomes (1)
Composite Through clinical physical examination data, behavioral indicators and multilevel omics data, to discover new sensitive biomarkers for evaluating aging.
- Aging atlas-R, PBMC RNA profiling, >5% DEGs.
- Aging atlas-P, proteomic profiling, >5% DEPs.
- Aging atlas-M, metabolic profiling, >5% metabolites.
- Aging atlas-B, metagenomic profiling, >5% microbiotas.
- Reduce human biological age complex parameters.
Measured: Baseline - 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2024
- Study start30 Jun 2024
- Primary completion30 Sep 2026 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for MetforminStudies of the same condition, open and under way.
- More trials run by Xuanwu Hospital, BeijingThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Collaborators
- Institute of Zoology, Chinese Academy of Sciences, Beijing Institute of Genomics, Chinese Academy of Sciences, Merck Serono Co., Ltd., China
- Responsible party
- Sponsor
- Investigators
- Guoguang Zhao, professor, Study chair, Xuanwu Hospital, BeijingGuoguang Zhao, professor, Principal investigator, Xuanwu Hospital, BeijingJing Li, professor, Study director, Xuanwu Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06459310
- Sponsor's protocol ID
- lijingxw
- Acronym
- AGE-M
- Status last verified
- Mar 2025
- First submitted
- 3 Jun 2024
- Last updated
- 21 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cabreiro F, Au C, Leung KY, Vergara-Irigaray N, Cocheme HM, Noori T, Weinkove D, Schuster E, Greene ND, Gems D. Metformin retards aging in C. elegans by altering microbial folate and methionine metabolism. Cell. 2013 Mar 28;153(1):228-39. doi: 10.1016/j.cell.2013.02.035.
PubMed 23540700Chai M, Jiang M, Vergnes L, Fu X, de Barros SC, Doan NB, Huang W, Chu J, Jiao J, Herschman H, Crooks GM, Reue K, Huang J. Stimulation of Hair Growth by Small Molecules that Activate Autophagy. Cell Rep. 2019 Jun 18;27(12):3413-3421.e3. doi: 10.1016/j.celrep.2019.05.070.
PubMed 31216464Foretz M, Guigas B, Bertrand L, Pollak M, Viollet B. Metformin: from mechanisms of action to therapies. Cell Metab. 2014 Dec 2;20(6):953-66. doi: 10.1016/j.cmet.2014.09.018. Epub 2014 Oct 30.
PubMed 25456737Garber AJ, Duncan TG, Goodman AM, Mills DJ, Rohlf JL. Efficacy of metformin in type II diabetes: results of a double-blind, placebo-controlled, dose-response trial. Am J Med. 1997 Dec;103(6):491-7. doi: 10.1016/s0002-9343(97)00254-4.
PubMed 9428832TODAY Study Group; Zeitler P, Hirst K, Pyle L, Linder B, Copeland K, Arslanian S, Cuttler L, Nathan DM, Tollefsen S, Wilfley D, Kaufman F. A clinical trial to maintain glycemic control in youth with type 2 diabetes. N Engl J Med. 2012 Jun 14;366(24):2247-56. doi: 10.1056/NEJMoa1109333. Epub 2012 Apr 29.
PubMed 22540912Gronich N, Rennert G. Beyond aspirin-cancer prevention with statins, metformin and bisphosphonates. Nat Rev Clin Oncol. 2013 Nov;10(11):625-42. doi: 10.1038/nrclinonc.2013.169. Epub 2013 Oct 1.
PubMed 24080598Kodali M, Attaluri S, Madhu LN, Shuai B, Upadhya R, Gonzalez JJ, Rao X, Shetty AK. Metformin treatment in late middle age improves cognitive function with alleviation of microglial activation and enhancement of autophagy in the hippocampus. Aging Cell. 2021 Feb;20(2):e13277. doi: 10.1111/acel.13277. Epub 2021 Jan 14.
PubMed 33443781Kulkarni AS, Gubbi S, Barzilai N. Benefits of Metformin in Attenuating the Hallmarks of Aging. Cell Metab. 2020 Jul 7;32(1):15-30. doi: 10.1016/j.cmet.2020.04.001. Epub 2020 Apr 24.
PubMed 32333835Li C, Mu N, Gu C, Liu M, Yang Z, Yin Y, Chen M, Wang Y, Han Y, Yu L, Ma H. Metformin mediates cardioprotection against aging-induced ischemic necroptosis. Aging Cell. 2020 Feb;19(2):e13096. doi: 10.1111/acel.13096. Epub 2020 Jan 14.
PubMed 31944526Williams-Herman D, Johnson J, Teng R, Golm G, Kaufman KD, Goldstein BJ, Amatruda JM. Efficacy and safety of sitagliptin and metformin as initial combination therapy and as monotherapy over 2 years in patients with type 2 diabetes. Diabetes Obes Metab. 2010 May;12(5):442-51. doi: 10.1111/j.1463-1326.2010.01204.x.
PubMed 20415693Neumann B, Baror R, Zhao C, Segel M, Dietmann S, Rawji KS, Foerster S, McClain CR, Chalut K, van Wijngaarden P, Franklin RJM. Metformin Restores CNS Remyelination Capacity by Rejuvenating Aged Stem Cells. Cell Stem Cell. 2019 Oct 3;25(4):473-485.e8. doi: 10.1016/j.stem.2019.08.015.
PubMed 31585093Martin-Montalvo A, Mercken EM, Mitchell SJ, Palacios HH, Mote PL, Scheibye-Knudsen M, Gomes AP, Ward TM, Minor RK, Blouin MJ, Schwab M, Pollak M, Zhang Y, Yu Y, Becker KG, Bohr VA, Ingram DK, Sinclair DA, Wolf NS, Spindler SR, Bernier M, de Cabo R. Metformin improves healthspan and lifespan in mice. Nat Commun. 2013;4:2192. doi: 10.1038/ncomms3192.
PubMed 23900241Ma T, Tian X, Zhang B, Li M, Wang Y, Yang C, Wu J, Wei X, Qu Q, Yu Y, Long S, Feng JW, Li C, Zhang C, Xie C, Wu Y, Xu Z, Chen J, Yu Y, Huang X, He Y, Yao L, Zhang L, Zhu M, Wang W, Wang ZC, Zhang M, Bao Y, Jia W, Lin SY, Ye Z, Piao HL, Deng X, Zhang CS, Lin SC. Low-dose metformin targets the lysosomal AMPK pathway through PEN2. Nature. 2022 Mar;603(7899):159-165. doi: 10.1038/s41586-022-04431-8. Epub 2022 Feb 23.
PubMed 35197629Lopez-Otin C, Blasco MA, Partridge L, Serrano M, Kroemer G. Hallmarks of aging: An expanding universe. Cell. 2023 Jan 19;186(2):243-278. doi: 10.1016/j.cell.2022.11.001. Epub 2023 Jan 3.
PubMed 36599349
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Exploratory Clinical Study Investigating the Geroprotective Effect of Metformin in Middle-aged and Elderly People
- ClinicalTrials.gov ID
- NCT06459310
- Acronym / sponsor ID
- AGE-M / lijingxw
- Keywords
- aging intervention, metformin, aging biomarker, multi-omics, middle-aged and elderly people, molecular clocks, biological age
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Collaborators
- Institute of Zoology, Chinese Academy of Sciences, Beijing Institute of Genomics, Chinese Academy of Sciences, Merck Serono Co., Ltd., China
- Study start
- 30 Jun 2024 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 14 Jun 2024 (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.
The objective of this research is to assess the efficacy of oral metformin in mitigating the aging process in middle-aged and elderly males, to pinpoint sensitive indicators of human senescence, and to offer innovative frameworks and scientific insights for pharmaceutical interventions in aging.
Detailed description
Subjects in both the metformin hydrochloride extended-release tablets treatment group and the placebo group received two tablets (500 mg each) once daily after dinner, continuing for a one-year period of drug intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metformin hydrochloride | Experimental | Drug: Metformin Hydrochloride tablet1000 mg/day Metformin hydrochloride extended-release tablets |
| Placebo group | Placebo comparator | Drug: Placebo1000 mg/day placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male
- Age 55-65; 18-28;
- Able to understand and execute instructions;
- After reading the consent form, be able to answer questions about the study and demonstrate understanding of the protocol;
- Be able to participate in regular follow-up visits.
Key exclusion criteria (8 listed)
- Severe chronic or acute disease: cancer, clinically significant congestive heart failure, chronic obstructive pulmonary disease (COPD), previous or new-onset diabetes, inflammatory state, serum creatinine >1.5 mg/dl , active liver disease, History of metabolic acidosis, poorly controlled hypertension, epilepsy, recent (within 3 months) cardiovascular events (MI, PTCA, CABG, stroke), severe renal insufficiency, inflammatory bowel disease, persistent glucocorticoids Treatment; neurological diseases such as dementia, AD, PD, etc.; infectious diseases such as HIV, hepatitis, tuberculosis, etc.; severe autoimmune diseases;
- BMI<18.5 or BMI>30;
- Persistent alcohol or drug abuse;
- Treatment with drugs known to affect glucose metabolism (other diabetes drugs, systemic glucocorticoids, niacin);
- Hypersensitivity to metformin or any component of the preparation;
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 |
|---|---|---|
| Metformin Hydrochloride tabletAlso: MetforminExtended release oral tablets, 1000 mg/day, single dose | Drug | Metformin hydrochloride |
| PlaceboOral tablets, 1000 mg/day, single dose | Drug | Placebo group |
Primary outcome
Composite the efficacy of metformin in intervening aging
Time frame: Baseline - 12 month
1. Metformin delay aging related sensitive indicators (2), such as SA*, ancient virus *. 2. Metformin inhibits markers of inflammation in the body (4), such as C1 protein *, CRP, CXCL9, TNFa. 3. Metformin improved immune cell-related indicators (10*), such as T1/T2/L gene expression. 4. Metformin improves metabolism-related indexes (4), such as metabolic secretion factors APOX1* and APOX2*. 5. Age-related indicators have been published (5), such as telomere length, DNA methylation age, hormone levels, etc.
1 secondary outcome
Composite Through clinical physical examination data, behavioral indicators and multilevel omics data, to discover new sensitive biomarkers for evaluating aging.
Time frame: Baseline - 12 month
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 Mar 2025.
- Background: PubMed 23540700Cabreiro F, Au C, Leung KY, Vergara-Irigaray N, Cocheme HM, Noori T, Weinkove D, Schuster E, Greene ND, Gems D. Metformin retards aging in C. elegans by altering microbial folate and methionine metabolism. Cell. 2013 Mar 28;153(1):228-39. doi: 10.1016/j.cell.2013.02.035.
- Background: PubMed 31216464Chai M, Jiang M, Vergnes L, Fu X, de Barros SC, Doan NB, Huang W, Chu J, Jiao J, Herschman H, Crooks GM, Reue K, Huang J. Stimulation of Hair Growth by Small Molecules that Activate Autophagy. Cell Rep. 2019 Jun 18;27(12):3413-3421.e3. doi: 10.1016/j.celrep.2019.05.070.
- Background: PubMed 25456737Foretz M, Guigas B, Bertrand L, Pollak M, Viollet B. Metformin: from mechanisms of action to therapies. Cell Metab. 2014 Dec 2;20(6):953-66. doi: 10.1016/j.cmet.2014.09.018. Epub 2014 Oct 30.
- Background: PubMed 9428832Garber AJ, Duncan TG, Goodman AM, Mills DJ, Rohlf JL. Efficacy of metformin in type II diabetes: results of a double-blind, placebo-controlled, dose-response trial. Am J Med. 1997 Dec;103(6):491-7. doi: 10.1016/s0002-9343(97)00254-4.
- Background: PubMed 22540912TODAY Study Group; Zeitler P, Hirst K, Pyle L, Linder B, Copeland K, Arslanian S, Cuttler L, Nathan DM, Tollefsen S, Wilfley D, Kaufman F. A clinical trial to maintain glycemic control in youth with type 2 diabetes. N Engl J Med. 2012 Jun 14;366(24):2247-56. doi: 10.1056/NEJMoa1109333. Epub 2012 Apr 29.
- Background: PubMed 24080598Gronich N, Rennert G. Beyond aspirin-cancer prevention with statins, metformin and bisphosphonates. Nat Rev Clin Oncol. 2013 Nov;10(11):625-42. doi: 10.1038/nrclinonc.2013.169. Epub 2013 Oct 1.
- Background: PubMed 33443781Kodali M, Attaluri S, Madhu LN, Shuai B, Upadhya R, Gonzalez JJ, Rao X, Shetty AK. Metformin treatment in late middle age improves cognitive function with alleviation of microglial activation and enhancement of autophagy in the hippocampus. Aging Cell. 2021 Feb;20(2):e13277. doi: 10.1111/acel.13277. Epub 2021 Jan 14.
- Background: PubMed 32333835Kulkarni AS, Gubbi S, Barzilai N. Benefits of Metformin in Attenuating the Hallmarks of Aging. Cell Metab. 2020 Jul 7;32(1):15-30. doi: 10.1016/j.cmet.2020.04.001. Epub 2020 Apr 24.
- Background: PubMed 31944526Li C, Mu N, Gu C, Liu M, Yang Z, Yin Y, Chen M, Wang Y, Han Y, Yu L, Ma H. Metformin mediates cardioprotection against aging-induced ischemic necroptosis. Aging Cell. 2020 Feb;19(2):e13096. doi: 10.1111/acel.13096. Epub 2020 Jan 14.
- Background: PubMed 20415693Williams-Herman D, Johnson J, Teng R, Golm G, Kaufman KD, Goldstein BJ, Amatruda JM. Efficacy and safety of sitagliptin and metformin as initial combination therapy and as monotherapy over 2 years in patients with type 2 diabetes. Diabetes Obes Metab. 2010 May;12(5):442-51. doi: 10.1111/j.1463-1326.2010.01204.x.
- Background: PubMed 31585093Neumann B, Baror R, Zhao C, Segel M, Dietmann S, Rawji KS, Foerster S, McClain CR, Chalut K, van Wijngaarden P, Franklin RJM. Metformin Restores CNS Remyelination Capacity by Rejuvenating Aged Stem Cells. Cell Stem Cell. 2019 Oct 3;25(4):473-485.e8. doi: 10.1016/j.stem.2019.08.015.
- Background: PubMed 23900241Martin-Montalvo A, Mercken EM, Mitchell SJ, Palacios HH, Mote PL, Scheibye-Knudsen M, Gomes AP, Ward TM, Minor RK, Blouin MJ, Schwab M, Pollak M, Zhang Y, Yu Y, Becker KG, Bohr VA, Ingram DK, Sinclair DA, Wolf NS, Spindler SR, Bernier M, de Cabo R. Metformin improves healthspan and lifespan in mice. Nat Commun. 2013;4:2192. doi: 10.1038/ncomms3192.
- 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.
Guoguang Zhao, professor study chair
Xuanwu Hospital, Beijing
Guoguang Zhao, professor principal investigator
Xuanwu Hospital, Beijing
Jing Li, professor study director
Xuanwu Hospital, Beijing
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 Metformin Hydrochloride tablet in people with Metformin and Aging, run by Xuanwu Hospital, Beijing 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 5 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 21 Mar 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 Lingling Geng (18510932169, gengll@xwhosp.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite the efficacy of metformin in intervening aging (time frame: Baseline - 12 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06459310, which also lists 14 linked publications.
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 Mar 2025; AzTrials last refreshed its copy on 4 Nov 2026.