A Phase 1a/1b Study of CB4211 in Healthy Non-obese Subjects and Subjects With Nonalcoholic Fatty Liver Disease

What Was Tested

The trial (phase 1) is built around MOTS-c for fatty liver & elevated liver enzymes.

It had ten arms (groups): one (experimental), Group A2 SAD (experimental), Group A3 SAD (experimental), Group A4 SAD (experimental) and Group A5 SAD (experimental).

The registry classes the interventions as drug.

Who Took Part

The registry lists 88 actual participants took part.

It was open to people of any sex aged from 18 years up to 60 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Males or females of nonchildbearing potential, of any race, 18 to 60 years of age, inclusive, at Screening. Body mass index between 18.0 and 30.0 kg/m2 , inclusive, with a minimum body weight of 50.0 kg at Screening. Males will agree to use contraception. Has maintained stable weight (by history) for at least 4 weeks prior to Screening. Agrees to the following:.

The full record lists 11 inclusion and 67 exclusion criteria; among the exclusions: history of alcoholism or drug/chemical abuse within 2 years prior to check-in; positive urine drug screen (confirmed by repeat) at screening or positive alcohol breath or urine test result or positive urine drug screen at check-in; use of tobacco- or nicotine-containing products within 3 months prior to check-in.

How the Study Was Run

It was run as a randomized, parallel-group and triple-blind study.

The fatty liver & elevated liver enzymes participants were allocated by chance, so the MOTS-c group and the comparison group should start out alike.

Groups ran in parallel: each of the fatty liver & elevated liver enzymes participants stayed in one arm throughout.

Blinding on both sides kept the fatty liver & elevated liver enzymes participants and researchers unaware of who received MOTS-c.

Those kept unaware of assignments: participant, care provider and investigator.

It started in 2018-07-09 with completion listed for 2021-04-19.

It ran at 4 sites in United States (4).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Incidence and severity of adverse events (AEs) (time frame: up to 8 weeks for Part A; up to 9 weeks for Part B; up to 12 weeks for Part C). Clinical laboratory evaluations (time frame: 7 days for Part A; 2 weeks for Part B; 5 weeks for Part C). Vital Signs (time frame: 7 days for Part A; 2 weeks for Part B; 5 weeks for Part C).

It also tracked 12 secondary outcomes, for example Area under the blood/plasma concentration time curve from time zero to infinity of CB4211, Area under the blood/plasma concentration time curve from time zero to the time of the last quantifiable concentration of CB4211, Area under the blood/plasma concentration time curve from time zero to 24 hours postdose of CB4211, Maximum observed blood/plasma concentration of CB4211, Time of the maximum observed blood/plasma concentration of CB4211 and Apparent blood/plasma terminal elimination half life of CB4211.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of MOTS-c in 88 people with fatty liver & elevated liver enzymes.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the MOTS-c compound page, Fatty liver & elevated liver enzymes research.