Recruiting
Early Phase 1

Metformin

Sponsor:

Medical College of Wisconsin

Code:

NCT07120971

Conditions

Bronchopulmonary Dysplasia (BPD)

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Interventions

Metformin (open-label)

Metformin (open-label)

Metformin (open-label)

Metformin (open-label)

Metformin (open-label)

Study Details

Brief summary:

The overall objective of this study is to investigate the role of metformin in decreasing lung injury and promoting lung growth in premature infants. There are two phases to this pilot study. For Phase 0, the goal is to investigate the safety and tolerance of oral metformin in premature who have been diagnosed with bronchopulmonary dysplasia (BPD) at 36-44 weeks gestation. For Phase 1, the goal is to investigate metformin safety and tolerance in extremely premature infants who are 7-30 days old who have an increased risk of BPD. The main questions it aims to answer are:

  • how well do older premature infants tolerate metformin?
  • how well do younger premature infants tolerate metformin?

Conditions

Bronchopulmonary Dysplasia (BPD)

Study ID

NCT07120971

Start date

Dec 19, 2025

Status verified date

Jan, 2026

Completion date

Sep 1, 2030

Anticipated

Primary completion date

Sep 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Inclusion Criteria Phase 0:

  • Birth gestational age of < 29 weeks AND
  • Postnatal age between 8 and 22 weeks AND
  • Diagnosed with BPD at 36 weeks postnatal age

Inclusion Criteria Phase 1:

  • Birth gestational age of < 29 weeks, AND
  • Requiring mechanical ventilation or positive pressure support at 7 days postnatal age, AND
  • Postnatal age between 7 and 30 days

Exclusion Criteria:

  • Persistent hypoglycemia
  • Lactic acidosis
  • Feeding intolerance
  • Renal or hepatic dysfunction
  • Active infection
  • Congenital anomalies that preclude feedings
  • Infants whose parents have chosen palliative care

Study Design

Enrollment

40 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Phase 0 - Cohort 1

5mg/kg/day in two divided doses for three days

experimental: Phase 0 - Cohort 2

10mg/kg/day in two divided doses for three days

experimental: Phase 0 - Cohort 3

20mg/kg/day in two divided doses for seven days

experimental: Phase 0 - Cohort 4

25mg/kg/day in two divided doses for 14 days

experimental: Phase 1 - Cohort 1 Escalation

15mg/kg/day in a single daily dose for three days

experimental: Phase 1 - Cohort 2 Escalation

25mg/kg/day in a single daily dose for three days

experimental: Phase 1- Cohort 3 Escalation

10mg/kg/day in a single daily dose for three days

experimental: Phase 1 - Cohort 4 Expansion

10-25mg/kg/day (dose selected from either Cohort 2 or 3)

experimental: Phase 1 - Cohort 5 Expansion

10-25mg/kg/day (dose selected from either Cohort 2 or 3)

Interventions

Metformin (open-label)

Enteric metformin 5mg/kg/day in two divided doses will be given for three days to two subjects

Metformin (open-label)

Enteric metformin 10mg/kg/day in two divided doses will be given for three days to two subjects.

Metformin (open-label)

Enteric metformin 20mg/kg/day in two divided doses will be given for seven days to three subjects.

Metformin (open-label)

Enteric metformin 25mg/kg/day in two divided doses will be given for 14 days to three subjects.

Metformin (open-label)

Enteric metformin 15mg/kg/day in a single daily dose will be given for three days to 3-6 subjects. Depending on tolerance, the next Cohort will increase to 25mg/kg/day (Cohort 2) or decrease to 10mg/kg/day (Cohort 3)

Metformin (open-label)

Enteric metformin 25mg/kg/day in a single daily dose will be given for three days to 3-6 subjects. Depending on tolerance, either 25mg/kg/day or 15mg/kg/day will be dose selected for the next Cohort (Cohort 4)

Metformin (open-label)

Enteric metformin 10mg/kg/day in a single daily dose will be given for three days to 3-6 subjects. Depending on tolerance, either 10mg/kg/day dose selected for the next Cohort (Cohort 4) or the study will be stopped due to excessive toxicity.

Metformin (open-label)

The dose for this cohort will be selected from either Cohort 2 or 3 based on tolerance. Enteric metformin 10-25mg/kg/day in a single daily dose will be given for seven days to 6 subjects.

Metformin (open-label)

The dose for this cohort will be the same as Cohort 4. Enteric metformin 10-25mg/kg/day in a single daily dose will be given for 14 days to 6 subjects.

Primary outcome measure

  • Number of participants who tolerate metformin [ Time Frame: 14 days after administration of the first dose of metformin ]
  • Number of participants with treatment-related adverse events [ Time Frame: 14 days after administration of the first dose of metformin ]
  • Number of participants with treatment-related metabolic acidosis [ Time Frame: 14 days after administration of the first dose of metformin ]
  • Number of subjects with treatment-related feeding problems [ Time Frame: 14 days after administration of the first dose of metformin ]
  • Number of subjects who require dose adjustments of metformin [ Time Frame: 14 days after administration of the first dose of metformin ]
  • Number of subjects with respiratory deterioration [ Time Frame: 14 days after administration of the first dose of metformin ]
  • Number of subjects who complete pharmacokinetic evaluation of metformin [ Time Frame: 14 days after administration of the first dose of metformin ]
  • Pharmacokinetic analysis of metformin [ Time Frame: 14 days after administration of the first dose of metformin ]
  • Number of subjects who complete the treatment protocol [ Time Frame: 14 days after administration of the first dose of metformin ]

Central Contacts and Locations

Central contacts

Kathleen Meskin, BSN, RN, CCRP

414-337-7171kmeskin@mcw.edu

Locations

Children's Wisconsin

Recruiting

Milwaukee, Wisconsin, United States, 53226

Contacts

Kathleen Meskin, BSN, RN, CCRP

414-337-7171kmeskin@mcw.edu

Principal Investigator:

G. Ganesh Konduri, MD, MS

More Information

Sponsor

Medical College of Wisconsin

Last update posted

Jan 26, 2026

Last verified

Jan, 2026

Keywords

  • bronchopulmonary dysplasia
  • BPD
  • prematurity
  • metformin

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Medical College of Wisconsin on 2026-01-26.