Safety and Efficacy of MET-3 in Obese Human Subjects

NCT03660748 | Completed Early Phase 1

• 1 other identifier: MET-3 101
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

A pilot study to explore the metabolic effect and safety of a 3-week course of therapy with MET-3 in obese subjects

Conditions

Obesity

Keywords

human microbiota

Outcome Measures

Primary Outcomes (1)

• 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.

  Treatment week 6

Secondary Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events

  Period beginning at enrollment and continuing through to end of treatment phase (week 6)

Study Arms (2)

Lower BMI

EXPERIMENTAL

Use of MET-2 in subjects with BMI of 30.0 to 34.9

Biological: MET-2

Higher BMI

EXPERIMENTAL

Use of MET-2 in subjects with BMI of 35 to 39.9

Biological: MET-2

Interventions

MET-2 BIOLOGICAL

Ingestion of a novel human microbiome preparation

Higher BMI; Lower BMI

Eligibility Criteria

• Age: 18 Years - 75 Years
• Gender Eligibility Details: 4 - 6 non-pregnant, non-lactating females in each group of 10 subjects
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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;

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• NuBiyota: lead
• Glycemic Index Laboratories, Inc: collaborator

Study Sites (1)

GI Labs

Toronto, Ontario, M5C2N8, Canada

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Thomas MS Wolever, MD/PhD

  GI Labs

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 28, 2018
• First Posted: September 7, 2018
• Study Start: October 1, 2018
• Primary Completion: January 22, 2020
• Study Completion: January 22, 2020
• Last Updated: August 11, 2020

Record last verified: 2018-09

Locations

CA (1)