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Prostate CancerPhase 3PRIMENCT03031821

Metformin in Patients Initiating ADT as Prevention and Intervention of Metabolic Syndrome

A Phase 3 study testing Metformin in people with Prostate Cancer and Metabolic Syndrome, run by Canadian Urologic Oncology Group at 16 sites in Canada.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This is a multi-centre, double-blind, randomized phase III trial comparing metformin to placebo in patients with advanced prostate cancer starting (or have recently started) androgen deprivation therapy (ADT). Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer, Metabolic Syndrome
What is being tested?
Metformin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
166 participants
Where
16 sitesCanada
Study dates
12 Jul 2018to 24 Nov 2023
Phase
Phase 3
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 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants must fulfill all the following criteria to be eligible for admission to the study:
  • Pathologically confirmed adenocarcinoma of the prostate
  • Eligible for initiating androgen deprivation therapy with either:
  • (Neo-)Adjuvant therapy for localized prostate cancer that is planned continuously for at least 9 months; or
  • Metastatic disease: or
  • Biochemical recurrence of prostate cancer as defined as EITHER:
Show all 15Show fewer
  • A rising PSA after prior curative intent surgical therapy (e.g., prostatectomy with or without adjuvant/ salvage radiotherapy). Since an absolute consensus for this value has not been established, if a rising PSA has been documented by at least two PSA values at least 2 weeks apart, the criteria for biochemical recurrence are deemed to have been met. Or,
  • PSA ≥ 2ng/mL above their nadir if previously treated with definitive radiotherapy
  • Serum testosterone > 5nmol/L (except for participants who have already started androgen deprivation therapy (within no more than 45 days of commencing study treatment)).
  • The choice of androgen deprivation therapy is at the investigators discretion but must include at minimum the use of luteinizing hormone-releasing hormone (LHRH) agonist/antagonist therapy. The addition of other hormonal agents (e.g., non-steroidal antiandrogens, abiraterone, enzalutamide, apalutamide) is allowed.
  • The androgen deprivation therapy undertaken can be intermittent or continuous, but the treatment intent must be declared prior to randomization.
  • Participant is able (e.g., sufficiently fluent) and willing to complete the quality of life questionnaires in either English or French. The baseline assessment must be completed within required timelines, prior to registration/randomization. Inability (lack of comprehension in English or French, or other equivalent reason such as cognitive issues or lack of competency) to complete the questionnaires will not make the participant ineligible for the study. However, ability but unwillingness to complete the questionnaires will make the participant ineligible.
  • Participant consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each participant must sign a consent form prior to enrolment in the trial to document their willingness to participate.
  • Participant must be accessible for treatment and follow up. Participants registered on this trial must be treated and followed at the participating centre. Investigators must assure themselves that the participants registered on this trial will be available for complete documentation of the treatment, adverse events, and follow-up.
  • Protocol treatment is to begin within 7 working days of participant randomization.

Who cannot join

  • Participants who fulfill any of the following criteria are not eligible for admission to the study:
  • Prior androgen deprivation therapy within 12 months of enrolment (except for participants who have started androgen deprivation therapy within 45 days of commencing study treatment)
  • Prior androgen deprivation therapy associated with definitive treatment is permitted, if it has been completed at least 12 months prior to enrolment (e.g., last injection or tablet taken 12 months prior to study enrolment)
  • Participant that meet ≥ 1 of the Canadian Diabetes Association criteria for the diagnosis of diabetes within 28 days of enrolment:
  • Fasting plasma glucose of ≥ 7mmol/L; or
  • HbA1C ≥ 6.5%.
Show all 18Show fewer
  • Participant currently taking metformin (or other diabetic medications) or who have taken metformin (or other diabetic medications) within 28 days of enrolment.
  • History of lactic acidosis or conditions that predispose to lactic acidosis:
  • Impaired Renal Function (eGFR <45mL/ minute/ 1.73 m^2); or
  • Liver disease, including alcoholic liver disease, as demonstrated by any of the following parameters:
  • AST > 1.8 x the upper limit of normal
  • ALT > 1.8 x the upper limit of normal
  • Alkaline Phosphatase >2x the upper limit of normal
  • Serum total bilirubin > 1.5x the upper limit of normal (except for participant with Gilbert's Disease who are eligible despite elevated serum bilirubin levels).
  • Alcohol abuse (habitual intake of ≥ 3 alcoholic beverages per day) sufficient to cause hepatic toxicity; or
  • Severe infection; or
  • Congestive heart failure (defined as New York Heart Association Class III or IV functional status).
  • Participant with a history of other invasive malignancies, except adequately treated non-melanoma skin cancer or other solid tumours curatively treated with no evidence of disease for ≥ 5 years.

Trial locations and contacts

16 sites in 1 country.

16 sites in 1 country

Canada16 sites

  • Tom Baker Cancer Centre

    Calgary, Alberta, T2S 3C3

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2

  • Central Newfoundland Regional Health Centre

    Grand Falls-Windsor, Newfoundland and Labrador, A2A 2E1

  • Northeast Cancer Centre

    Greater Sudbury, Ontario, P3E 5J1

  • CHU de Quebec - Universite Laval

    Laval, Quebec

  • Centre Hospitalier de L'Universite de Montreal (CHUM)

    Montreal, Quebec, H2X 0A9

  • McGill University Health Center-Cedar Cancer Center

    Montreal, Quebec, H4A 3J1

  • Horizon Health Network

    Saint John, New Brunswick, E3B 4R3

  • Ciusss-Chus

    Sherbrooke, Quebec, J1H 5N4

  • Dr. H. Bliss Murphy Cancer Centre

    St. John's, Newfoundland and Labrador, A1B 8V6

  • Sunnybrook Research Institue

    Toronto, Ontario, M4N 3M5

  • Princess Margaret Cancer Centre (Princess Margaret Hospital)

    Toronto, Ontario, M5G 2M9

  • Centre Intégré Universitaire de Santé et de Services Sociaux de la Mauricie-Centre-du-Québec / Centre hospitalier régional

    Trois-Rivières, Quebec, G8Z 3R9

  • Vancouver Prostate Centre

    Vancouver, British Columbia, V5Z 1M9

  • BC Cancer Agency - Vancouver Cancer Centre

    Vancouver, British Columbia, V5Z 4E6

  • Cancer Care Manitoba

    Winnepeg, Manitoba, R3E 0V9

Other trials in Canada

About this study

Official title: A Randomized Phase 3 Trial of Metformin in Patients Initiating Androgen Deprivation Therapy as Prevention and Intervention of Metabolic Syndrome: The Prime Study

This is a multi-centre, double-blind, randomized phase III trial comparing metformin to placebo in patients with advanced prostate cancer starting (or have recently started) androgen deprivation therapy (ADT).

Read the detailed description

The primary objective of this study will determine if there are differences between arms with respect to the proportion of participants who meet the diagnostic criteria for metabolic syndrome after 18 months of study treatment.

The investigators will also compare arms with regards to severity of individual metabolic syndrome components following 18 months of study treatment. Other objectives are outlined below, and will include quality of life assessments, metabolic and anthropomorphic measurements at additional time points and correlative laboratory studies.

It is estimated that one in seven Canadian men will be diagnosed with prostate cancer in their lifetime. In 2015, approximately 23,600 Canadian men were estimated to be diagnosed with prostate cancer and 4,000 died of this disease.

Androgen deprivation therapy (ADT) is a standard first-line treatment for men with incurable prostate cancer and has long been known to improve overall survival.

Although the effectiveness of ADT is well established in participants with advanced prostate cancer, it is associated with important adverse effects as outlined below. The development of metabolic syndrome in particular is clinically important as it is associated with worsened quality of life and increased all-cause morbidity and mortality.

As ADT is now employed, alone or in combination with other therapies, in virtually all men with advanced prostate cancer for increasingly long periods of time (median survival of men presenting with newly diagnosed metastatic disease from recent clinical trials is at least 3 years, during which they are typically on continuous hormonal therapy), the burden of ADT toxicity among men with prostate cancer is significant and increasing.

The investigators hypothesize that the addition of metformin to a program of ADT will reduce the proportion of participants with metabolic syndrome at 18 months after initiation of ADT and will reduce the severity of individual components of metabolic syndrome in men with advanced prostate cancer. To test this hypothesis, this is a randomized, double-blinded, placebo-controlled phase 3 clinical trial of metformin in patients undergoing ADT treatment.

Being tested
Metformin, Placebo Oral Tablet
Keywords
Prostate Cancer, ADT, Metabolic Syndrome, Androgen Deprivation Therapy, Phase III, Phase 3, Randomized
Medical subject headings
Prostatic Neoplasms, Metabolic Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MetforminDrug

    Metformin Duration: 18 months 850 mg PO OD x 30 days then 850 mg PO BID for duration

  • Placebo Oral TabletDrug

    Also called Placebo

    Placebo Oral Tablet Duration 18 months

    1 tablet (850 mg) PO OD x 30 days then 1 tablet PO BID for duration

Study groups in NCT03031821
Study groupRoleWhat they receive
MetforminExperimentalMetformin 850 mg PO OD X 30 days, then 850mg PO BID for a total of 18 months
Receives: Drug: Metformin
PlaceboPlacebo comparatorPlacebo Oral Tablet 1 tablet (850mg) PO OD X 30 days, then 850mg PO BID for a total of 18 months
Receives: Drug: Placebo Oral Tablet

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of participants who meet the diagnostic criteria for metabolic syndrome after 18 months of study treatment

    A diagnosis of metabolic syndrome will be made according to the harmonized definition of the metabolic syndrome as defined in the joint statement of the International Diabetes Federation Task Force on Epidemiology and Prevention; National Heart, Lung and Blood Institute; American Heart Association; World Heart Federation; International Atherosclerosis Society; and the International Association for the Study of Obesity. A patient will be classified as having metabolic syndrome if he possesses ≥3 of the aforementioned criteria: Increased waist circumference, elevated triglycerides, reduced high-density lipoprotein cholesterol, elevated blood pressure, and elevated fasting blood glucose.

    The prevalence of metabolic syndrome at 18 months post randomization will be calculated and compared between treatment arms using the two-sample t-test.

    Measured: 18 months

Secondary outcomes (10)

  1. Proportion of participants who meet the diagnostic criteria for metabolic syndrome after 9 months of study treatment

    A diagnosis of metabolic syndrome will be made according to the harmonized definition of the metabolic syndrome as defined in the joint statement of the International Diabetes Federation Task Force on Epidemiology and Prevention; National Heart, Lung and Blood Institute; American Heart Association; World Heart Federation; International Atherosclerosis Society; and the International Association for the Study of Obesity. A patient will be classified as having metabolic syndrome if he possesses ≥3 of the aforementioned criteria: Increased waist circumference, elevated triglycerides, reduced high-density lipoprotein cholesterol, elevated blood pressure, and elevated fasting blood glucose.

    The prevalence of metabolic syndrome at 9 months post randomization will be calculated and compared between treatment arms using the two-sample t-test.

    Measured: 9 months

  2. Proportion of participants who meet the diagnostic criteria for metabolic syndrome after 12 months of study treatment

    A diagnosis of metabolic syndrome will be made according to the harmonized definition of the metabolic syndrome as defined in the joint statement of the International Diabetes Federation Task Force on Epidemiology and Prevention; National Heart, Lung and Blood Institute; American Heart Association; World Heart Federation; International Atherosclerosis Society; and the International Association for the Study of Obesity. A patient will be classified as having metabolic syndrome if he possesses ≥3 of the aforementioned criteria: Increased waist circumference, elevated triglycerides, reduced high-density lipoprotein cholesterol, elevated blood pressure, and elevated fasting blood glucose.

    The prevalence of metabolic syndrome at 12 months post randomization will be calculated and compared between treatment arms using the two-sample t-test.

    Measured: 12 months

  3. Proportion of participants who meet the diagnostic criteria for metabolic syndrome after 24 months of study treatment

    A diagnosis of metabolic syndrome will be made according to the harmonized definition of the metabolic syndrome as defined in the joint statement of the International Diabetes Federation Task Force on Epidemiology and Prevention; National Heart, Lung and Blood Institute; American Heart Association; World Heart Federation; International Atherosclerosis Society; and the International Association for the Study of Obesity. A patient will be classified as having metabolic syndrome if he possesses ≥3 of the aforementioned criteria: Increased waist circumference, elevated triglycerides, reduced high-density lipoprotein cholesterol, elevated blood pressure, and elevated fasting blood glucose.

    The prevalence of metabolic syndrome at 24 months post randomization will be calculated and compared between treatment arms using the two-sample t-test.

    Measured: 24 months

  4. Proportion of participants who meet the criteria of reduced high-density lipoprotein cholesterol assessed at 18 months of follow-up.

    Reduced High-Density Lipoprotein Cholesterol defined as: < 1.0 mmol/L; or drug treatment for reduced HDL cholesterol*

    *Patient taking fibrates (Bezafibrate, Ciprofibrate, Clofibrate, Gemfibrozil, or Fenofibrate) or nicotinic acid can be presumed to have high TG and reduced HDL-cholesterol levels; Patients taking high dose omega-3 fatty acids can be presumed to have high TG levels

    Measured: 18 months

  5. Proportion of participants who meet the criteria of elevated triglycerides assessed at 18 months of follow-up.

    Elevated Triglycerides defined as: ≥1.7 mmol/L; or drug treatment for elevated triglycerides*

    *Patient taking fibrates (Bezafibrate, Ciprofibrate, Clofibrate, Gemfibrozil, or Fenofibrate) or nicotinic acid can be presumed to have high TG and reduced HDL-cholesterol levels; Patients taking high dose omega-3 fatty acids can be presumed to have high TG levels

    Measured: 18 months

  6. Proportion of participants who meet the criteria of elevated blood pressure assessed at 18 months of follow-up.

    Elevated Blood Pressure defined as:

    Systolic Blood Pressure of ≥ 130 mm of Hg; or Diastolic Blood Pressure of ≥ 85 mm of Hg; or drug treatment for elevated blood pressure

    Blood pressures will be taken with patients sitting for 5 minutes in a quiet environment prior to measurement and two measurements taken (with a minimum of 5 minutes between each blood pressure measurement), with the mean recorded for this study.

    Measured: 18 months

  7. Proportion of participants who meet the criteria of elevated fasting blood glucose levels assessed at 18 months of follow-up.

    Elevated Fasting Blood Glucose defined as:

    HbA1c ≥ 6.5%; or Fasting plasma glucose ≥ 7.0 mmol/L; or drug treatment for elevated blood glucose

    Measured: 18 months

  8. Proportion of participants who meet the criteria of increased waist circumference assessed at 18 months of follow-up.

    Increased Waist Circumference defined as:

    Males (population and country specific) A) Canadians ≥102cm B) Chinese ≥ 85cm C) Japanese ≥ 85 cm D) Other Asians ≥ 90 cm E) Middle Eastern \& Mediterranean ≥ 94cm F) Sub-Saharan African ≥ 94 cm G) Central \& South American ≥ 90cm H) Europid ≥ 94 cm

    Measurement of waist circumference will be performed by a dedicated research nurse for this study that is blinded to the patient's treatment allocation.

    Measured: 18 months

  9. Health-related Quality of Life assessed at 18 months of follow-up.

    Patients will undergo quality of life measurements by the EORTC QLQ-C30 core questionnaire (63) and prostate-specific module. The instruments are well validated and widely used in the population of interest. The questionnaire items are transformed for 5 functional domains, global QOL, and specific symptom scales/items relevant to the study intervention.

    The statistical analysis plan will use the standard CCTG QOL approach (Osoba et al., 1998), and will focus on change of mean scores from baseline over time by treatment allocation group. Depending on the amount of missing data, generalized linear equation modeling of mean scores may be required. The analysis will also consider the proportion of patients improved, stable or deteriorated at 18 months compared to baseline using a cut-point minimal clinical difference of 10 points on all scales. A sensitivity analysis will be executed using a cut-point of 7 points.

    Measured: 18 months

  10. Treatment-related toxicity

    Treatment related toxicity (NCI CTCAE 4.0)

    All men will be evaluated for toxicity from the time of their first oral dose of study medication. Toxicities will be graded using the current CTCAE version 4.0. The incidence of toxicities by arm will be summarized by type of adverse effect. A Fisher's Exact Test will be used to compare toxicities between the two arms.

    Measured: 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jan 2017 (estimated)
  2. Study start12 Jul 2018
  3. Primary completion24 Nov 2023
  4. Study completion24 Nov 2023

Why it stopped: Manufacturer discontinued the production of study drugs.

Resources

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 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
166 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03031821
Sponsor's protocol ID
PRIME
Acronym
PRIME
Status last verified
Oct 2024
First submitted
20 Jan 2017
Last updated
29 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Canadian Cancer Society. Canadian Cancer Statistics 2015: Canadian Cancer Society; 2015 [Available from: http://www.cancer.ca/].

  • Crook JM, O'Callaghan CJ, Duncan G, Dearnaley DP, Higano CS, Horwitz EM, Frymire E, Malone S, Chin J, Nabid A, Warde P, Corbett T, Angyalfi S, Goldenberg SL, Gospodarowicz MK, Saad F, Logue JP, Hall E, Schellhammer PF, Ding K, Klotz L. Intermittent androgen suppression for rising PSA level after radiotherapy. N Engl J Med. 2012 Sep 6;367(10):895-903. doi: 10.1056/NEJMoa1201546.

    PubMed 22931259

  • Hussain M, Tangen CM, Berry DL, Higano CS, Crawford ED, Liu G, Wilding G, Prescott S, Kanaga Sundaram S, Small EJ, Dawson NA, Donnelly BJ, Venner PM, Vaishampayan UN, Schellhammer PF, Quinn DI, Raghavan D, Ely B, Moinpour CM, Vogelzang NJ, Thompson IM Jr. Intermittent versus continuous androgen deprivation in prostate cancer. N Engl J Med. 2013 Apr 4;368(14):1314-25. doi: 10.1056/NEJMoa1212299.

    PubMed 23550669

  • Lakka HM, Laaksonen DE, Lakka TA, Niskanen LK, Kumpusalo E, Tuomilehto J, Salonen JT. The metabolic syndrome and total and cardiovascular disease mortality in middle-aged men. JAMA. 2002 Dec 4;288(21):2709-16. doi: 10.1001/jama.288.21.2709.

    PubMed 12460094

  • Malik S, Wong ND, Franklin SS, Kamath TV, L'Italien GJ, Pio JR, Williams GR. Impact of the metabolic syndrome on mortality from coronary heart disease, cardiovascular disease, and all causes in United States adults. Circulation. 2004 Sep 7;110(10):1245-50. doi: 10.1161/01.CIR.0000140677.20606.0E. Epub 2004 Aug 23.

    PubMed 15326067

  • Mottillo S, Filion KB, Genest J, Joseph L, Pilote L, Poirier P, Rinfret S, Schiffrin EL, Eisenberg MJ. The metabolic syndrome and cardiovascular risk a systematic review and meta-analysis. J Am Coll Cardiol. 2010 Sep 28;56(14):1113-32. doi: 10.1016/j.jacc.2010.05.034.

    PubMed 20863953

  • Solymoss BC, Bourassa MG, Campeau L, Sniderman A, Marcil M, Lesperance J, Levesque S, Varga S. Effect of increasing metabolic syndrome score on atherosclerotic risk profile and coronary artery disease angiographic severity. Am J Cardiol. 2004 Jan 15;93(2):159-64. doi: 10.1016/j.amjcard.2003.09.032.

    PubMed 14715340

  • Miettola J, Niskanen LK, Viinamaki H, Sintonen H, Kumpusalo E. Metabolic syndrome is associated with impaired health-related quality of life: Lapinlahti 2005 study. Qual Life Res. 2008 Oct;17(8):1055-62. doi: 10.1007/s11136-008-9386-6. Epub 2008 Aug 31.

    PubMed 18759109

  • Park SS, Yoon YS, Oh SW. Health-related quality of life in metabolic syndrome: The Korea National Health and Nutrition Examination Survey 2005. Diabetes Res Clin Pract. 2011 Mar;91(3):381-8. doi: 10.1016/j.diabres.2010.11.010. Epub 2010 Dec 4.

    PubMed 21134699

  • Ford ES, Li C. Metabolic syndrome and health-related quality of life among U.S. adults. Ann Epidemiol. 2008 Mar;18(3):165-71. doi: 10.1016/j.annepidem.2007.10.009.

    PubMed 18280918

  • Nguyen PL, Alibhai SM, Basaria S, D'Amico AV, Kantoff PW, Keating NL, Penson DF, Rosario DJ, Tombal B, Smith MR. Adverse effects of androgen deprivation therapy and strategies to mitigate them. Eur Urol. 2015 May;67(5):825-36. doi: 10.1016/j.eururo.2014.07.010. Epub 2014 Aug 2.

    PubMed 25097095

  • James ND, Sydes MR, Clarke NW, Mason MD, Dearnaley DP, Spears MR, Ritchie AW, Parker CC, Russell JM, Attard G, de Bono J, Cross W, Jones RJ, Thalmann G, Amos C, Matheson D, Millman R, Alzouebi M, Beesley S, Birtle AJ, Brock S, Cathomas R, Chakraborti P, Chowdhury S, Cook A, Elliott T, Gale J, Gibbs S, Graham JD, Hetherington J, Hughes R, Laing R, McKinna F, McLaren DB, O'Sullivan JM, Parikh O, Peedell C, Protheroe A, Robinson AJ, Srihari N, Srinivasan R, Staffurth J, Sundar S, Tolan S, Tsang D, Wagstaff J, Parmar MK; STAMPEDE investigators. Addition of docetaxel, zoledronic acid, or both to first-line long-term hormone therapy in prostate cancer (STAMPEDE): survival results from an adaptive, multiarm, multistage, platform randomised controlled trial. Lancet. 2016 Mar 19;387(10024):1163-77. doi: 10.1016/S0140-6736(15)01037-5. Epub 2015 Dec 21.

    PubMed 26719232

  • Mohler JL, Armstrong AJ, Bahnson RR, D'Amico AV, Davis BJ, Eastham JA, Enke CA, Farrington TA, Higano CS, Horwitz EM, Hurwitz M, Kane CJ, Kawachi MH, Kuettel M, Lee RJ, Meeks JJ, Penson DF, Plimack ER, Pow-Sang JM, Raben D, Richey S, Roach M 3rd, Rosenfeld S, Schaeffer E, Skolarus TA, Small EJ, Sonpavde G, Srinivas S, Strope SA, Tward J, Shead DA, Freedman-Cass DA. Prostate Cancer, Version 1.2016. J Natl Compr Canc Netw. 2016 Jan;14(1):19-30. doi: 10.6004/jnccn.2016.0004.

    PubMed 26733552

  • Kylin E. Studien ueber das Hypertonie-Hyperglykaemie-Hyperurikaemiesydrom. Zentralblatt fuer Innere Medizin. 1923;44:105-27.

  • Reaven GM. Banting lecture 1988. Role of insulin resistance in human disease. Diabetes. 1988 Dec;37(12):1595-607. doi: 10.2337/diab.37.12.1595.

    PubMed 3056758

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Metformin in people with Prostate Cancer and Metabolic Syndrome, run by Canadian Urologic Oncology Group at 16 sites in Canada.

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 15 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: stopped early, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in Canada. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Manufacturer discontinued the production of study drugs.). Results are not available in the source record.

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?

Proportion of participants who meet the diagnostic criteria for metabolic syndrome after 18 months of study treatment (time frame: 18 months). 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 NCT03031821, which also lists 72 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 29 Jul 2026.

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