A Study to Assess Safety, Tolerability, and Pharmacokinetics of MEDI0382 in Non-diabetic Obese Participants

What Was Tested

The trial (phase 1) is built around Cotadutide.

This is a Phase 1, randomized, blinded, placebo-controlled study in up to approximately 51 non-diabetic obese participants with a body mass index (BMI) ≥ 35 kg/m\^2.

The participants will be observed among 3 separate cohorts and participate in the study for up to approximately 27 weeks, including a screening period (including a run-in), treatment period, and safety follow-up.

It had six arms (groups): Placebo Cohort 1 (placebo comparator), MEDI0382 Cohort 1 (experimental), Placebo Cohort 2 (placebo comparator), MEDI0382 Cohort 2 (experimental) and Placebo Cohort 3 (placebo comparator).

Participants will receive subcutaneous (SC) placebo matched to MEDI0382 Cohort 1 once daily for 9 weeks.

Participants will receive SC placebo matched to MEDI0382 Cohort 2 once daily for 14 weeks.

The registry classes the interventions as drug.

More on the Plan

This is a Phase 1, randomized, blinded, placebo-controlled study in up to approximately 51 non-diabetic obese participants with a BMI ≥ 35 kg/m2.

The participants will participate in the study for up to approximately 27 weeks, including a screening period (including a run-in), treatment period, and safety follow-up.

Participants will be randomized 4:1 to MEDI0382 (n=12) or placebo (n=3) for Cohort 1 and randomized 2:1 to MEDI0382 (n=12) or placebo (n=6) for Cohorts 2 and 3.

In Cohort 2 participants randomized to MEDI0382 or placebo will be dosed daily with a 2 week titration schedule up to the highest CTD is established in Cohort 1.

Who Took Part

The registry lists 51 actual participants took part.

It was open to people of any sex aged from 18 years up to 65 years.

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

Examples of who could join: Provision of written informed consent. Male and female participants age 18 through 65 years. BMI ≥ 35 kg/m\^2. Female participants must have a negative pregnancy test and must not be lactating. Females of childbearing potential using appropriate birth control to avoid pregnancy during the study.

The full record lists 9 inclusion and 11 exclusion criteria; among the exclusions: active participation in any other investigation clinical study; any prescription or non-prescription drugs for weight loss including herbal or other dietary supplements used within the past 3 months prior to screening; previous glucagon-like peptide-1 (glp-1) use within 3 months prior to screening.

How the Study Was Run

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

The participants were allocated by chance, so the Cotadutide group and the comparison group should start out alike.

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

As a double-blind Cotadutide study, the assignments were hidden from both participants and investigators until the end.

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

It started in 2018-08-14 with completion listed for 2019-08-25.

It ran at 2 sites in United States (2).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) for Cohorts 1, 2, and 3. Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs for Cohorts 1, 2, and 3. Number of Participants With Abnormal Vital Signs and Physical Examinations Reported as TEAEs for Cohorts 1, 2, and 3.

It also tracked 9 secondary outcomes, for example Maximum Observed Plasma Concentration (Cmax) of MEDI0382 for Cohort 1, Time to Maximum Observed Plasma Concentration (Tmax) of MEDI0382 for Cohort 1, Plasma Concentration of MEDI0382 for Cohorts 2 and 3 and Number of Participants With Positive Anti-Drug Antibodies (ADA) to MEDI0382 in all Cohorts.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Cotadutide in 51 people.

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

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