Recruiting
Phase 2

Metformin

Sponsor:

Johns Hopkins University

Code:

NCT06273072

Conditions

Asthma

Asthma Chronic

Overweight and Obesity

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Metformin hydrochloride extended-release tablets

Visually identical placebo Metformin hydrochloride extended-release tablets

Study Details

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

Study ID

NCT06273072

Start date

Dec 9, 2024

Status verified date

Jan, 2026

Completion date

Dec 31, 2028

Anticipated

Primary completion date

Sep 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Metformin hydrochloride extended-release tablets

Metformin hydrochloride extended-release tablets 2000 mg once daily

placebo comparator: Visually identical placebo tablets

Placebo tablet once daily

Interventions

Metformin hydrochloride extended-release tablets

titrated to 2000 mg once daily

Visually identical placebo Metformin hydrochloride extended-release tablets

placebo

Primary outcome measure

  • Number of completed telemedicine visits [ Time Frame: Baseline to week 24 ]
  • Adherence to study drug [ Time Frame: Baseline to week 24 ]
  • Retention rate [ Time Frame: Baseline to week 24 ]

Central Contacts and Locations

Central contacts

Rachelle Koehl, M.S.

410-955-1530rkoehl1@jhmi.edu

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

410-550-6205mmccor16@jhmi.edu

Locations

Johns Hopkins University

Recruiting

Baltimore, Maryland, United States, 21224

Contacts

Rachelle Koehl

410-955-1530rkoehl1@jhmi.edu

Principal Investigator:

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

Baylor College of Medicine

Recruiting

Houston, Texas, United States, 77030

More Information

Sponsor

Johns Hopkins University

Last update posted

Jan 16, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Johns Hopkins University on 2026-01-16.