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

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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:

  • Provision of written informed consent
  • Male and female participants age 18 through 65 years
  • BMI ≥ 35 kg/m^2
  • Hemoglobin A1c level of < 6.5%
  • 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.
  • Stable body weight
  • 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
  • Willing and able to self-administer daily SC injections following an initial self-injection training

Key Exclusion Criteria:

  • Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks prior to Study Day 1 dosing.
  • 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.
  • 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.
  • Any positive results for serum hepatitis B surface antigen, hepatitis C virus antibody and/or human immunodeficiency virus (HIV) antibody at screening.
  • Laboratory tests results as specified in the protocol (laboratory tests may be repeated once for confirmation of out of range values at screening).
  • Significant hepatic or renal impairment
  • Poorly controlled hypertension
  • Known or suspected history of drug or alcohol abuse within the past year or positive current test
  • Previous surgical procedures for weight loss

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

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

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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