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

• Status: Completed
• Trial end date: 2019-08-25
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: MedImmune LLC

Criteria

Key Inclusion Criteria:

1. Provision of written informed consent

2. Male and female participants age 18 through 65 years

3. BMI ≥ 35 kg/m^2

4. Hemoglobin A1c level of < 6.5%

5. Female participants must have a negative pregnancy test and must not be lactating.

6. Females of childbearing potential using appropriate birth control to avoid pregnancy during the study.

7. Stable body weight

8. Willing and able to adhere to the visit/protocol schedule, including following lifestyle advice with respect to diet and exercise for the duration of the study

9. Willing and able to self-administer daily SC injections following an initial self-injection training

Key Exclusion Criteria:

1. Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks prior to Study Day 1 dosing.

2. Any condition that, in the opinion of the investigator, would interfere with the evaluation of the investigational product or interpretation of participants safety or study results.

3. Active participation in any other investigation clinical study.

4. Any prescription or non-prescription drugs for weight loss including herbal or other dietary supplements used within the past 3 months prior to screening.

5. Previous glucagon-like peptide-1 (GLP-1) use within 3 months prior to screening.

6. Any positive results for serum hepatitis B surface antigen, hepatitis C virus antibody and/or human immunodeficiency virus (HIV) antibody at screening.

7. Laboratory tests results as specified in the protocol (laboratory tests may be repeated once for confirmation of out of range values at screening).

8. Significant hepatic or renal impairment

9. Poorly controlled hypertension

10. Known or suspected history of drug or alcohol abuse within the past year or positive current test

11. Previous surgical procedures for weight loss