Metformin IN Asthma for Overweight and Obese Individuals (MINA)

NCT06273072 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: IRB00409080R34HL166438-01A1
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

This is a randomized clinical trial of metformin among overweight or obese adults with not well-controlled asthma despite maintenance inhaler therapy.

Conditions

Asthma; Asthma Chronic; Overweight and Obesity

Outcome Measures

Primary Outcomes (3)

• Number of completed telemedicine visits

  Number of participants completing at least 3 out of the 4 monitoring telemedicine visits

  Baseline to week 24

• Adherence to study drug

  Adherence will be measured by pill count

  Baseline to week 24

• Retention rate

  Investigators will collect data on the number of subjects screened, randomized, and complete the final in-person visit

  Baseline to week 24

Secondary Outcomes (5)

• Asthma control as assessed by the Asthma Control Test (ACT) score

  Baseline to week 24

• Change in Asthma exacerbations rate

  Baseline to week 24

• Pre-bronchodilator lung function

  Baseline to week 24

• Fractional exhaled nitric oxide (FeNO)

  Baseline to week 24

• Airways hyperresponsiveness

  Baseline to week 24

Study Arms (2)

Metformin hydrochloride extended-release tablets

ACTIVE COMPARATOR

Metformin hydrochloride extended-release tablets 2000 mg once daily

Drug: Metformin hydrochloride extended-release tablets

Visually identical placebo tablets

PLACEBO COMPARATOR

Placebo tablet once daily

Drug: Visually identical placebo Metformin hydrochloride extended-release tablets

Interventions

Metformin hydrochloride extended-release tablets DRUG

titrated to 2000 mg once daily

Metformin hydrochloride extended-release tablets

Visually identical placebo Metformin hydrochloride extended-release tablets DRUG

placebo

Visually identical placebo tablets

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Physician-diagnosed asthma on maintenance therapy
• Not well-controlled asthma (ACT score \<20, or at least one asthma exacerbation requiring corticosteroids in the prior 12 months)
• Overweight or obesity: Body mass index ≥25kg/m2
• Adult: Age ≥18

You may not qualify if:

• Currently pregnant, expect to become pregnant in the next 6 months or are currently breastfeeding
• Major cardiovascular disease: heart failure, heart attack or stroke within the last 6 months
• Other chronic lung disease, inclusive of chronic obstructive pulmonary disease, bronchiectasis, interstitial lung disease, pulmonary fibrosis
• Active smoking or former smoker with ≥20 pack-year smoking history
• Chronic kidney disease: estimated glomerular filtration rate ≤60 mL/min/1.73 m2
• Heavy alcohol use: in a typical week, 8 or more drinks for a woman or 15 or more drinks for a man
• Liver disease: elevation in aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 2x the upper limit of normal or prior diagnosis of liver disease
• Anemia: hemoglobin \< 13 g/dl in males and hemoglobin \< 11 g/dl in females
• Taking Glucagon Like Peptide 1(GLP-1) medications for weight loss
• Diabetes (Hemoglobin A1C ≥ 6.5% or taking metformin or other medications used to treat diabetes)
• Participation in any other clinical trial (observational studies are permitted)

Sponsors & Collaborators

• Johns Hopkins University: lead
• Baylor College of Medicine: collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• Temple University: collaborator

Study Sites (2)

Johns Hopkins University

Baltimore, Maryland, 21224, United States

RECRUITING

Baylor College of Medicine

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

Asthma; Overweight; Obesity

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Meredith C McCormack, M.D., M.H.S.

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

• Tianshi D Wu, M.D., M.H.S.

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rachelle Koehl, M.S.

CONTACT

410-955-1530; rkoehl1@jhmi.edu

Meredith C McCormack, M.D., M.H.S.

CONTACT

410-550-6205; mmccor16@jhmi.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2024
• First Posted: February 22, 2024
• Study Start: December 9, 2024
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): December 31, 2028
• Last Updated: January 16, 2026

Record last verified: 2026-01

Locations

US (2)