Safety, Pharmacokinetics and Efficacy of Bimagrumab in Overweight and Obese Patients With Type 2 Diabetes

What Was Tested

This registered phase 2 trial tested Bimagrumab.

It had two arms (groups): one (experimental) and Placebo (placebo comparator).

The registry classes the interventions as drug and other.

More on the Plan

The study consisted of a screening baseline period of 3 weeks, treatment period of 48 weeks and then a follow-up period of 8 weeks.

Treatment period visits were scheduled every 4 weeks until week 44.

Administration of bimagrumab or placebo was done via an i.v. infusion over 30 minutes followed by flushing for 15 minutes.

Who Took Part

Enrollment: 78 actual participants took part.

It was open to people of any sex aged from 18 years up to 75 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Body Mass Index of 28 to 40 kg/m2 at screening. Body weight between 65 and 140 kg at screening.

The full record lists 4 inclusion and 13 exclusion criteria; among the exclusions: use of anti-obesity medications, nutritional supplements or over the counter products for weight loss within 3 months of screening; use of medications known to induce weight gain such as some anti-convulsant and psychotropic medications within 3 months of screening; any chronic active infection (e.g., hiv, hepatitis b or c, tuberculosis, etc) or has received anti-hcv treatments within the previous 6 months.

How the Study Was Run

Design: randomized, parallel-group and quadruple-blind.

Because people in this Bimagrumab study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Bimagrumab group and the comparison group ran side by side rather than switching.

Neither the participants nor the staff measuring them knew who was on Bimagrumab, so expectations could not easily colour the readings.

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

It started in 2017-02-01 with completion listed for 2019-03-21.

It ran at 9 sites in United States (8) and United Kingdom (1).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change From Baseline in Total Body Fat Mass by Dual Energy X-ray Absorptiometry (DXA) at Week 48 (time frame: Baseline, Week 48).

It also tracked 12 secondary outcomes, for example Change From Baseline in Total Body Fat Mass by Dual Energy X-ray Absorptiometry (DXA) at Week 24, Change From Baseline in HbA1c at Week 24 and 48, Maximum Observed Serum Concentration(Cmax) Derived on Day 1, 168 and 308, Time to Reach the Maximum Concentration After Drug Administration (Tmax) Derived on Day 168 and 308, Change From Baseline in Body Mass Index (BMI) and Change From Baseline in Weight.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Bimagrumab in 78 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Bimagrumab compound page, all human trials.