Multiple Ascending Dose Study of AMG 598 in Adults With Obesity

Amgen50 enrolled

Overview

The main objective of this study is to assess the safety and tolerability of multiple doses of AMG 598 administered alone or in combination with liraglutide in adults with obesity.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Enrollment

Conditions

Obesity

Interventions

AMG 598DRUG

AMG 598 administered by subcutaneous injection

PlaceboDRUG

Placebo matching to AMG 598 administered by subcutaneous injection

LiraglutideDRUG

Liraglutide administered by subcutaneous injection. The starting dose is 0.6 mg/day, and increased by 0.6 mg/day dose increment every 7 days, up to the full dosage of 3.0 mg/day by week 5.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Men and women with ages between 18 and 65 years old, inclusive, at time of signing consent * Body mass index (BMI) between greater than or equal to 30.0 kg/m\^2 and less than or equal to 40.0 kg/m\^2 at screening * Except for obesity, otherwise healthy or medically stable per protocol * Have a stable body weight defined as less than 5 kg self-reported change during the previous 8 weeks prior to screening * Other Inclusion criteria may apply * Stable on liraglutide, depending on cohort Exclusion Criteria: * History or clinical evidence of diabetes * Inadequate organ function at screening * Currently receiving treatment in another investigational device or drug study * Women who are pregnant/lactating/breastfeeding or who plan to become pregnant/breastfeed while on study through 5 months after receiving the last dose of investigational product * History or evidence of a clinically significant disorder, condition or disease that would pose a risk to subject safety or interfere with the study evaluation, procedures or completion * A family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2; a personal history of non-familial medullary thyroid carcinoma; confirmed chronic pancreatitis or idiopathic acute pancreatitis, or gallbladder disease (ie, cholelithiasis or cholecystitis) not treated with cholecystectomy, for cohorts receiving liraglutide * History of major depressive disorder * Other Exclusion criteria may apply

Locations (4)

William D Summers MD LLC

Birmingham, Alabama, United States

Orange County Research Center

Tustin, California, United States

QPS Miami Research Associates

South Miami, Florida, United States

Dallas Diabetes and Endocrine Center

Dallas, Texas, United States

Outcomes

Primary Outcomes

Number of Participants With Treatment-emergent Adverse Events

The investigator assessed the severity of each adverse event reported during the study. The assessment was based on the Amgen Standard Grading Scale: Mild: Aware of sign or symptom, but easily tolerated. Moderate: Discomfort enough to cause interference with usual activity. Severe: Incapacitating with inability to work or do usual activity. A Serious adverse event is defined as any untoward medical occurrence that, met at least 1 of the following serious criteria * Death; * Was life-threatening; * Required in-patient hospitalization or prolongation of existing hospitalization; * Resulted in persistent or significant disability/incapacity; * Was a congenital anomaly/birth defect; * Other medically important serious event. The investigator also assessed whether each adverse event was related to study drug administration based on clinical judgement.

Time frame: 207 days

Number of Participants With TEAEs Due to Laboratory, Electrocardiogram, and Vital Sign Findings

TEAEs due to laboratory, electrocardiogram (ECG) and vital sign findings include any abnormal laboratory test results (hematology, clinical chemistry, or urinalysis) or electrocardiogram, or vital signs measurements, including those that worsened from baseline, that were considered clinically significant in the medical and scientific judgment of the investigator (ie, not related to progression of underlying disease).

Time frame: 207 days

Secondary Outcomes

Maximum Observed Concentration (Cmax) of AMG 598 After Subcutaneous Injection on Day 1 and Day 57

Serum concentrations of AMG 598 were determined using a validated electrochemiluminescence-based method. The lower limit of quantitation was 50.0 ng/mL.

Time frame: Day 1, predose, and days 6, 8, 15, 22, and 29; Day 57 predose and days 62, 64, 71, 85, 99, 113, 127, 169, and 207

Time to Maximum Observed Concentration (Tmax) of AMG 598 After Subcutaneous Injection on Day 1 and Day 57

Serum concentrations of AMG 598 were determined using a validated electrochemiluminescence-based method. The lower limit of quantitation was 50.0 ng/mL.

Data from ClinicalTrials.gov

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