ObesityEarly Phase 1NCT03660748
Safety and Efficacy of MET-3 in Obese Human Subjects
A Early Phase 1 study testing MET-2 in people with Obesity, run by NuBiyota at 1 site in Canada.
Trial summary
A pilot study to explore the metabolic effect and safety of a 3-week course of therapy with MET-3 in obese subjects Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Obesity
- What is being tested?
- MET-2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteCanada
- Study dates
- 1 Oct 2018to 22 Jan 2020
- Phase
- Early Phase 1
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or non-pregnant, non-lactating females who are taking adequate contraceptive precaution, aged 18 to 75 years inclusive;
- BMI ≥30.0 kg/m2 and <40.0 kg/m2;
- Stable body weight (±4 kg) for the past 4 months with no intention to gain or lose weight;
- Fasting serum triglycerides <6 mmol/L (<532 mg/dL) at screening;
- Fasting serum glucose <7.0 mmol/L (<126 mg/dl) and A1c<6.5% at screening
- Blood pressure <160/100.
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- AST, ALT and ALP ≤1.8 times the upper limit of normal (liver function) at screening;
- Serum creatinine < 1.5 times the upper limit of normal (kidney function) at screening;
- At least one of the following:
- Fasting serum glucose >5.6 mmol/L
- HbA1c > 6.0%
- Fasting triglycerides >1.70 mmol/L (150 mg/dl)
- AST > upper limit of normal
- Blood pressure, systolic >140 mmHg and/or diastolic >90 mmHg
- Willing to maintain habitual diet, physical activity pattern, and body weight throughout the trial;
- Willing to abstain from strenuous exercise, consuming alcoholic drinks 24 hours before study days and during study days;
- Willing to maintain current dietary supplement and medication use throughout the trial. On test days, subject agrees to bring any dietary supplements or medications taken in the morning with them to GI labs to take just prior to the glucose test meal;
- Subject is not currently participating nor recently (within 30 days of screening) participated in a clinical trial involving long-term exposure (greater than 24 hours) to an investigational drug, nutritional supplement or lifestyle modification;
- Understanding the study procedures and willing to provide informed consent to participate in the study and authorization to release relevant protected health information to the study investigator and other authorized agents as indicated in the consent form
Who cannot join
- Failure to meet any one of the inclusion criteria.
- Smokers
- Hemoglobin measurements of <120g/L for females and <130g/L for males (as per World Health Organization [WHO] criteria for anemia)
- Known history of acquired immune deficiency syndrome (AIDS), hepatitis, a history or presence of clinically important endocrine conditions (including Type 1 or Type 2 diabetes mellitus), pulmonary, biliary or gastrointestinal (GI) disorders or new onset cardiovascular disease within 6 months of screening (including, but not limited to, atherosclerotic disease, history of myocardial infarction, peripheral arterial disease, stroke).
- Use of medications known to influence carbohydrate metabolism, gastrointestinal function or appetite, including, but not limited to adrenergic blockers, diuretics, thiazolidinediones, metformin and systemic corticosteroids within 4 weeks of the screening visit, or with any condition which might, in the opinion of the Investigator, either: 1) make participation dangerous to the subject or to others, 2) affect the results, or 3) influence the ability of the subject to comply with study procedures.
- Major trauma or surgical event within 3 months of screening.
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- Unwillingness or inability to comply with the experimental procedures and to follow GI Labs safety guidelines.
- Known intolerance, sensitivity or allergy to any ingredients in the investigational agent.
- Extreme dietary habits, as judged by the Investigator (i.e. Atkins diet, very high protein diets, etc.).
- Uncontrolled hypertension (systolic blood pressure ≥160 mm Hg or diastolic blood pressure ≥100 mm Hg as defined by the average blood pressure measured at screening.
- Presence of any signs or symptoms of an active infection within 5 d prior to any test visit. If an infection occurs during the study period, test visits should be rescheduled until all signs and symptoms have resolved and any treatment (i.e. antibiotic therapy) has been completed at least 5 d prior to each test visit.
- History of cancer in the prior two years, except for non-melanoma skin cancer.
- Recent history (within 12 months of screening) or strong potential for alcohol or substance abuse. Alcohol abuse is defined as > 14 drinks per week (1 drink=12 oz beer, 5 oz wine, or 1.5 oz distilled spirits).
- Pregnancy or breastfeeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Open-Label, Single-Centre Study of the Safety and Efficacy of Microbial Ecosystem Therapeutics (MET)-3 in Obese Human Subjects
A pilot study to explore the metabolic effect and safety of a 3-week course of therapy with MET-3 in obese subjects
Read the detailed description
This is an open label, single center, uncontrolled pilot study of 20 participants; each group will receive a different dose of MET-3. Each group will have 4-6 females, 4-6 participants with BMI 30.0-34.9 kg/m² and the remainder with BMI 35-39.9 kg/m.
- Conditions
- Obesity
- Being tested
- MET-2
- Keywords
- human microbiota
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MET-2Biological
Ingestion of a novel human microbiome preparation
| Study group | Role | What they receive |
|---|---|---|
| Lower BMI | Experimental | Use of MET-2 in subjects with BMI of 30.0 to 34.9 Receives: Biological: MET-2 |
| Higher BMI | Experimental | Use of MET-2 in subjects with BMI of 35 to 39.9 Receives: Biological: MET-2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of MET-3 on the Incremental Area under the glucose curve (2 hrs) in obese subjects
The area under the glucose curve in obese subjects will be measured 2 hours after a 75 g oral glucose challenge. This measurement will be made at baseline and then again after 6 weeks of treatment with MET-3.
Measured: Treatment week 6
Secondary outcomes (1)
Incidence of Treatment-Emergent Adverse Events
Adverse Events,Complete blood count (CBC), aspartate transaminase (AST), alanine aminotransferase (ALT), Alkaline phosphatase (ALP), bilirubin, urea, amylase, creatinine and electrolytes
Measured: Period beginning at enrollment and continuing through to end of treatment phase (week 6)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2018
- Study start1 Oct 2018
- Primary completion22 Jan 2020
- Study completion22 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study design is open label, single center, uncontrolled pilot study of 20 participants divided into 2 groups of 10; each group will receive a different dose of MET-3. Each group will have 4-6 females, 4-6 participants with BMI 30.0-34.9 kg/m² and the remainder with BMI 35-39.9 kg/m.
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- NuBiyota
- Sponsor type
- University, hospital or other
- Collaborators
- Glycemic Index Laboratories, Inc
- Responsible party
- Sponsor
- Investigators
- Thomas MS Wolever, MD/PhD, Principal investigator, GI Labs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03660748
- Sponsor's protocol ID
- MET-3 101
- Status last verified
- Sep 2018
- First submitted
- 28 Aug 2018
- Last updated
- 11 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-Label, Single-Centre Study of the Safety and Efficacy of Microbial Ecosystem Therapeutics (MET)-3 in Obese Human Subjects
- ClinicalTrials.gov ID
- NCT03660748
- Acronym / sponsor ID
- MET-3 101
- Conditions
- Obesity
- Keywords
- human microbiota
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- NuBiyotaUniversity, hospital or other
- Collaborators
- Glycemic Index Laboratories, Inc
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 22 Jan 2020 (actual)
- Study completion
- 22 Jan 2020 (actual)
- First posted
- 7 Sep 2018 (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.
A pilot study to explore the metabolic effect and safety of a 3-week course of therapy with MET-3 in obese subjects
Detailed description
This is an open label, single center, uncontrolled pilot study of 20 participants; each group will receive a different dose of MET-3. Each group will have 4-6 females, 4-6 participants with BMI 30.0-34.9 kg/m² and the remainder with BMI 35-39.9 kg/m.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study design is open label, single center, uncontrolled pilot study of 20 participants divided into 2 groups of 10; each group will receive a different dose of MET-3. Each group will have 4-6 females, 4-6 participants with BMI 30.0-34.9 kg/m² and the remainder with BMI 35-39.9 kg/m.
| Arm | Type | Receives |
|---|---|---|
| Lower BMI | Experimental | Biological: MET-2Use of MET-2 in subjects with BMI of 30.0 to 34.9 |
| Higher BMI | Experimental | Biological: MET-2Use of MET-2 in subjects with BMI of 35 to 39.9 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Male or non-pregnant, non-lactating females who are taking adequate contraceptive precaution, aged 18 to 75 years inclusive;
- BMI ≥30.0 kg/m2 and <40.0 kg/m2;
- Stable body weight (±4 kg) for the past 4 months with no intention to gain or lose weight;
- Fasting serum triglycerides <6 mmol/L (<532 mg/dL) at screening;
- Fasting serum glucose <7.0 mmol/L (<126 mg/dl) and A1c<6.5% at screening
Key exclusion criteria (14 listed)
- Failure to meet any one of the inclusion criteria.
- Smokers
- Hemoglobin measurements of <120g/L for females and <130g/L for males (as per World Health Organization [WHO] criteria for anemia)
- Known history of acquired immune deficiency syndrome (AIDS), hepatitis, a history or presence of clinically important endocrine conditions (including Type 1 or Type 2 diabetes mellitus), pulmonary, biliary or gastrointestinal (GI) disorders or new onset cardiovascular disease within 6 months of screening (including, but not limited to, atherosclerotic disease, history of myocardial infarction, peripheral arterial disease, stroke).
- Use of medications known to influence carbohydrate metabolism, gastrointestinal function or appetite, including, but not limited to adrenergic blockers, diuretics, thiazolidinediones, metformin and systemic corticosteroids within 4 weeks of the screening visit, or with any condition which might, in the opinion of the Investigator, either: 1) make participation dangerous to the subject or to others, 2) affect the results, or 3) influence the ability of the subject to comply with study procedures.
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 |
|---|---|---|
| MET-2Ingestion of a novel human microbiome preparation | Biological | Higher BMI, Lower BMI |
Primary outcome
Effect of MET-3 on the Incremental Area under the glucose curve (2 hrs) in obese subjects
Time frame: Treatment week 6
The area under the glucose curve in obese subjects will be measured 2 hours after a 75 g oral glucose challenge. This measurement will be made at baseline and then again after 6 weeks of treatment with MET-3.
1 secondary outcome
Incidence of Treatment-Emergent Adverse Events
Time frame: Period beginning at enrollment and continuing through to end of treatment phase (week 6)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2020.
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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. This study is not recruiting at the moment.
Thomas MS Wolever, MD/PhD principal investigator
GI Labs
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing MET-2 in people with Obesity, run by NuBiyota at 1 site 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 19 inclusion and 14 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: finished, as of the sponsor's last update on 11 Aug 2020. 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 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. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Effect of MET-3 on the Incremental Area under the glucose curve (2 hrs) in obese subjects (time frame: Treatment week 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Aug 2020; AzTrials last refreshed its copy on 8 Nov 2026.