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

MedImmune

Status and phase: Completed; Phase 1

Conditions: Obesity

Treatments: Drug: Placebo; Drug: MEDI0382

Study type: Interventional

Funder types: Industry

Identifiers

NCT03625778

D5672C00001

Details and patient eligibility

About

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.

Full description

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. Participants will be blinded, but investigators/site staff and sponsor will be unblinded for Cohort 1. In Cohorts 2 and 3 participants, investigators, and contract research organization personnel are blinded to investigational product and sponsor is unblinded. 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 1 participants randomized to MEDI0382 or placebo will be dosed daily with a weekly titration schedule until the highest clinically tolerated dose (CTD) is established. 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. In Cohort 3 participants randomized to MEDI0382 or placebo will be dosed daily with a 4 week participants schedule up to the highest CTD established in Cohort 1. Once the highest CTD is identified, participants will continue on the highest CTD for an additional 2 weeks of treatment for Cohort 1 and 3 and additional 4 weeks treatment for Cohort 2. All participants will return 28 days post last dose for a safety follow-up visit.

Enrollment: 51 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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51 participants in 6 patient groups, including a placebo group

Placebo Cohort 1

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

MEDI0382 Cohort 1

Experimental group

Description:

Participants will receive SC MEDI0382 titrated doses of Dose 1 to 7 once daily (7-step titration/ 1 week per dose) from Weeks 1 to 7 followed by additional treatment of SC MEDI0382 Dose 7 once daily from Weeks 7 to 9.

Treatment:

Drug: MEDI0382

Placebo Cohort 2

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

MEDI0382 Cohort 2

Experimental group

Description:

Participants will receive SC MEDI0382 titrated doses of Doses 1, 2, 3, 5, and 7 once daily (5-step titration/ 2 week per dose) from Weeks 1 to 10 followed by additional treatment of SC MEDI0382 Dose 7 once daily from Weeks 11 to 14.

Treatment:

Drug: MEDI0382

Placebo Cohort 3

Placebo Comparator group

Description:

Participants will receive SC placebo matched to MEDI0382 Cohort 3 once daily for 18 weeks.

Treatment:

Drug: Placebo

MEDI0382 Cohort 3

Experimental group

Description:

Participants will receive SC MEDI0382 titrated doses of Doses 1, 8, 4, and 7 once daily (4-step titration/ 4 week per dose) from Weeks 1 to 16 followed by additional treatment of SC MEDI0382 Dose 7 once daily from Weeks 17 to 18.

Treatment:

Drug: MEDI0382