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Overweight and ObesityPhase 2MetfluoNCT03051451

Fixed Dose Combination of Fluoxetin and Metformin in the Management of Overweight and Obesity

A Phase 2 study testing combination metformin hydrochloride/ fluoxetine 500/20 mg and combination metformin hydrochloride/ fluoxetine 1000/20mg in people with Overweight and Obesity, run by Laboratorios Silanes S.A. de C.V. at 1 site in Mexico.

Suspended

Paused. Enrolment is on hold for now and may resume.

Official record
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Trial summary

Clinical trial, multicenter, double-blind, placebo-controlled, comparative of three parallel groups, randomized treatment to assess the efficacy and safety using a fixed dose combination of metformin hydrochloride with fluoxetine as adjunctive treatment in patient with obesity or overweight in order to generate new… Read more about this study

Who is it for?
Ages 18 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Overweight and Obesity
What is being tested?
combination metformin hydrochloride/ fluoxetine 500/20 mg and combination metformin hydrochloride/ fluoxetine 1000/20mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
150 participants
Where
1 siteMexico
Study dates
Start not givento Nov 2018
Phase
Phase 2
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 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Signature of consent informed
  • Men and Women.
  • ≥ 18 years old proven through a current official identification.
  • BMI ≥ 30 kg/m2 with or without Comorbidities.
  • BMI ≥ 27 kg/m2 with a diagnosis of comorbidities by patient's clinical record associated with overweight (DM2's recent diagnosis without treatment, hypertension, dyslipidemia, sleep apnea or secondary heart disease) defined as follows:
  • DM2 of current diagnosis study inclusion unless not receive drug treatment, with a HbA1c ≥6. 5 and and < 8.5%.
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  • Arterial Systemic Hypertension with figures < 140 / 90 mmHg.
  • Dyslipidemia with total cholesterol levels> 200 mg / dl and <240 mg / dl, and / or LDL-C> 100 and <160 mg / dl and / or triglycerides> 150 mg / dl and <400 mg / dl.
  • In case of have drug treatment for hypertension or dyslipidemia, the participants must have a stable dose for at least 3 months prior to the elective visit.
  • Women in childbearing age must use a reliable method of birth control, such as barrier methods (condom, diaphragm), fallopian tube obstruction, intrauterine device.

Who cannot join

  • Endogenous obesity (endocrine diseases that condition gain of weight, such as hypothyroidism, syndrome of Cushing).
  • Background of patient's clinical record history of iatrogenic obesity (use of drugs that determine weight gain, such as corticosteroids, antipsychotic and antiepileptic).
  • Thyroid stimulating Hormone (TSH) is out of range.
  • Prolongation of the QT interval corrected for rate (QTc) segment by electrocardiogram with the formula of prolonged Bazett (greater than 450 msec. in males and 470 msec in women).
  • Creatinine ≥1. 3 mg/dl in women and ≥1. 5 mg/dl in men.
  • Alanine transaminase(ALT) or Aspartate Aminotransferase (AST) > 2 times above from the normal value.
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  • Background of patient's clinical record of depressive disorder or anxiety that - may require therapy with psychiatric drugs.
  • Intolerance known to drugs in the study.
  • Pregnancy or breastfeeding.
  • Use of medications, supplements or other techniques whose objective is the reduction of weight.
  • Use of medications contraindicated with drugs study.

Trial locations and contacts

1 site in 1 country.

Mexico1 site
  • Laboratorios SIlanes S.A. de C.V,

    Mexico City, Mexico City, 03100

Other trials in Mexico

About this study

Official title: Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Determine the Efficacy of Two Fixed Dose Combination of Metformin/Fluoxetin 1000/40 mg vs. 1700/40 mg in the Management of Overweight and Obesity

Clinical trial, multicenter, double-blind, placebo-controlled, comparative of three parallel groups, randomized treatment to assess the efficacy and safety using a fixed dose combination of metformin hydrochloride with fluoxetine as adjunctive treatment in patient with obesity or overweight in order to generate new knowledge and give a greater number of therapeutic options to the clinicians, one group will receive metformin 1700 mg and 40 mg of fluoxetine; Another group will receive metformin 1000 mg with 40 mg of fluoxetine, and a third group called control will receive placebo.

The above described treatments will be administered according to the "Dosage Schedule" The three groups will receive tablets of physical characteristics equal to the reference drug to preserve the blinding.

Read the detailed description

Overweight and obesity are serious health problems that affect population around the world. According to information of the World Health Organization (WHO) in 2014 more than 1.9 billion of inhabitants older than 18 years had overweight, of which 600 million were obese, i.e., 39% of adults at global level present overweight and 13% of adults suffer obesity.

Overweight and obesity are considered complex and multifactorial diseases associated with the development of multiple co-morbidities such as certain types of cancer, cardiovascular diseases (CVD), disability, diabetes mellitus type 2 (DM2), disease of gallbladder, osteoarthritis, high blood pressure (Hypertension), sleep apnea and cerebrovascular disease (CD), making it the fifth leading cause of death worldwide , and is therefore considered a pandemic.

Obesity is defined as the increase of the weight body associated to an imbalance in the proportions of the different components of the body, in which mainly, the mass fat increases with abnormal distribution in the body.The Body Mass Index (BMI) is the standard most widely used for the classification of the somatotype in the people, and therefore the identification of obesity. BMI is obtained through by dividing the weight in kilograms between heights in squared meters. The classification of the BMI for White, Hispanic, and African-American adult people has been approved by the National Institute of Heart, Lung and Blood, the WHO, the American Association of Heart, the American College of Cardiology and the Obesity Society, whose classification is the following:

The weight body is determined by the balance energy, which represents the difference between the intake of energy through the food and the expenditure of energy coming of physical activity of an individual. For the maintenance of a stable body weight, the energy intake must be equal to energy expenditure, that's when weight gain happens, when the intake exceeds expenditure, which produces a positive energy balance. On the other hand, weight loss occurs when energy expenditure exceeds the caloric intake.

Although the low expenditure of energy represents one of the main factors that produce an increase in the weight, there are multiple factors that play an important role. These factors include genetic predisposition of the individual, physical inactivity and sedentary behavior, socio-economic factors, as well as emotional factors and consumption of certain types of drugs.

Due to the multiple factors that have an influence in the development of overweight and obesity, the treatment is complex, because there must be some type of treatment by a multidisciplinary team that achieve the control of each one of the factors that condition obesity of each individual.

Traditional treatments for loss weight have been given in the education of the individual on the preference for healthy foods, prescription diets and the implementation of programs of physical activity. However, various studies have shown that this type of intervention has few effects in long term, so the incorporation of new strategies as adjuvants in the loss of weight have been developed, which include surgical techniques and pharmacological therapies.

According to the guidelines for obesity, the drug treatment therapy should be recommended in individuals with a BMI ≥30 kg/m2 or with a BMI of ≥27 kg/m2 and the presence of a comorbidity. 6. The use of pharmacological therapies must always be used as adjuvants to changes in lifestyle, and must be approved by health authorities of each country. Before 2012, phentermine and orlistat were the unique medications available for the treatment of obesity in the United States; however in 2015 the Repertoire of pharmacological agents available to treat the obesity was extended and incorporated 4 new drugs: lorcaserin, phentermine / topiramate of prolonged release, naltrexone / wellbutrin of prolonged release and liraglutide. These new drugs share a common strategy to promote weight loss that controls hunger and satiation at the level of the central nervous system (CNS), besides that most of them have been previously used for the treatment of a medical condition other than obesity. The amount of weight lost that is achieved through the use of these agents, usually goes from 3 to 10% of the initial weight and requires a continuous to hold the loss of weight. In addition, each of these drugs has a unique profile of adverse events that should be considered deeply prior to be indicated.

Due to the above, the search for new drug therapies for the obesity treatment is one of the priorities in the research. Some drugs developed for different therapeutic indications have shown significant effects on weight loss, which include metformin hydrochloride and fluoxetine

Being tested
combination metformin hydrochloride/ fluoxetine 500/20 mg, combination metformin hydrochloride/ fluoxetine 1000/20mg, Placebo Oral Tablet
Keywords
Hydrochloride of Metformin / Fluoxetine, Placebo, Obesity
Medical subject headings
Overweight, Obesity

What participants receive

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

  • combination metformin hydrochloride/ fluoxetine 500/20 mgDrug

    Group A will receive metformin 1000 mg and 40 mg of fluoxetine; after the increment phase.

    All treatment groups will receive, in addition to the intervention, recommendations of a diet based on a hyper protein, hypo caloric and low carbohydrate diet as well as an exercise routine according to age and physical condition

  • combination metformin hydrochloride/ fluoxetine 1000/20mgDrug

    Group B will receive metformin 1700 mg and 40 mg of fluoxetine; after the increment phase.

    All treatment groups will receive, in addition to the intervention, recommendations of a diet based on a hyper protein, hypo caloric and low carbohydrate diet as well as an exercise routine according to age and physical condition

  • Placebo Oral TabletDrug

    Group C will receive placebo oral tablet; All treatment groups will receive, in addition to the intervention, recommendations of a diet based on a hyper protein, hypo caloric and low carbohydrate diet as well as an exercise routine according to age and physical condition

Study groups in NCT03051451
Study groupRoleWhat they receive
combination metformin hydrochloride/ fluoxetine 500/20 mgActive comparatorDosage: The dose will depend on the period of treatment in which the patient is: * Single dose treatment (from visit 2 (from day 0 to day 30 ± 7), the patient will take 1 metformin hydrochloride tablet 500 mg / fluoxetine 20 mg and 1 placebo tablet , every 24 hours in the morning for 30 days). * Treatment at double dose (from visit 3 and until visit 8), the patient will take 2 tablets of metformin hydrochloride 500 mg / fluoxetine 20 mg and 2 tablets of Placebo, every 24 hours in the morning for 150 days).
Receives: Drug: combination metformin hydrochloride/ fluoxetine 500/20 mg
combination metformin hydrochloride/ fluoxetine 1000/20mgActive comparatorDosage: The dose will depend on the period of treatment in which the patient is: * Single dose treatment (from visit 2 (from day 0 to day 30 ± 7), the patient will take 1 metformin hydrochloride tablet 850 mg / fluoxetine 20 mg and 1 placebo tablet , every 24 hours in the morning for 30 days). * Treatment at double dose (from visit 3 and until visit 8), the patient will take 2 tablets of metformin hydrochloride 850 mg / fluoxetine 20 mg and 2 tablets of Placebo, every 24 hours in the morning for 150 days).
Receives: Drug: combination metformin hydrochloride/ fluoxetine 1000/20mg
Placebo Oral TabletPlacebo comparatorPlacebo
Receives: Drug: Placebo Oral Tablet

What is being measured

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

  1. Decrease of at least 5% of body weight and the reduction in the body mass index.

    Compare BMI after 6 months of treatment with hydrochloride of metformin / fluoxetine. In two doses (1000/40 mg) and (1700/40 mg) or placebo.

    Measured: six months

Secondary outcomes (10)
  1. Body weight

    the mass of the body in kilograms

    Measured: six months

  2. Height

    expressed in meters

    Measured: six months

  3. Body Mass Index

    relationship between weight and height, used to classify underweight, overweight and obesity, calculated by dividing the weight in kilograms by the square of the height in meters

    Measured: six months

  4. Waist-hip index (hip circumference)

    The waist hip index will be obtained by measuring the waist perimeter in centimeters at the last floating rib level and the maximum hip perimeter at the gluteal level.

    Measured: six months

  5. Blood pressure measurement

    The blood pressure measurement will be performed with a calibrated and verified sphygmomanometer in mm/Hg

    Measured: six months

  6. Fasting glucose concentration

    Glucose concentrations in mg/dl from blood serum will be determined in patients in fasting condition

    Measured: six months

  7. Insulin levels

    Serum insulin levels in µl/ml will be quantified using an enzyme immunoassay technique

    Measured: six months

  8. concentrations of lipid profile

    Percentage of reduction of cholesterol levels in mg/dl after 6 months of treatment.

    Measured: six months

  9. fat mass

    Measured by bioimpedance

    Measured: six months

  10. concentrations of lipid profile

    Percentage of reduction LDL-C and / or triglycerides in mg/dl after 6 months of treatment

    Measured: six months

Timeline

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

  1. First posted13 Feb 2017
  2. Primary completionMay 2018 (estimated)
  3. Study completionNov 2018 (estimated)

Why it stopped: Business decision

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03051451
Sponsor's protocol ID
30050/II/16
Acronym
Metfluo
Status last verified
Aug 2017
First submitted
2 Dec 2016
Last updated
1 Sep 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Kokkorakis M, Chakhtoura M, Rhayem C, Al Rifai J, Ghezzawi M, Valenzuela-Vallejo L, Mantzoros CS. Emerging pharmacotherapies for obesity: A systematic review. Pharmacol Rev. 2025 Jan;77(1):100002. doi: 10.1124/pharmrev.123.001045. Epub 2024 Nov 22.

    PubMed 39952695

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing combination metformin hydrochloride/ fluoxetine 500/20 mg and combination metformin hydrochloride/ fluoxetine 1000/20mg in people with Overweight and Obesity, run by Laboratorios Silanes S.A. de C.V. at 1 site in Mexico.

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 10 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: paused, as of the sponsor's last update on 1 Sep 2017. 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 Mexico. 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?

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?

Decrease of at least 5% of body weight and the reduction in the body mass index. (time frame: six 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 NCT03051451, which also lists 1 linked publication.

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 1 Sep 2017.

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