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Completed

NCT Number: NCT03757130

Multiple Ascending Dose Study of AMG 598 in Adults With Obesity

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.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

William D Summers MD LLC, Birmingham, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AMG 598

Drug

AMG 598 administered by subcutaneous injection

Placebo

Drug

Placebo matching to AMG 598 administered by subcutaneous injection

liraglutide

Drug

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.

Other names: Saxenda®

Primary outcomes

  1. Number of Participants With Treatment-emergent Adverse Events

    Time frame: 207 days

    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.

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

    Time frame: 207 days

    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).

Secondary outcomes

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

    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

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

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

    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

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

  3. Dose-normalized Cmax of AMG 598 After Subcutaneous Injection on Day 1 and Day 57

    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

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

  4. Area Under the Concentration-time Curve From Time 0 to 28 Days (AUC0-28) for AMG 598 After Subcutaneous Injection on Day 1 and Day 57

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

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

  5. Dose-normalized AUC0-28 for AMG 598 After Subcutaneous Injection on Day 1 and Day 57

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

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

  6. Area Under the Concentration-time Curve From Time 0 to Time of Last Quantifiable Concentration (AUClast) of AMG 598 After Subcutaneous Injection on Day 57

    Time frame: Day 57 predose and days 62, 64, 71, 85, 99, 113, 127, 169, and 207

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

  7. Accumulation Ratio (AR) for Cmax of AMG 598 After Subcutaneous Injection on Day 1 and Day 57

    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

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

    Accumulation ratio for Cmax = Day 57 Cmax / Day 1 Cmax.

  8. Accumulation Ratio of AUC0-28 for AMG 598 After Subcutaneous Injection on Day 1 and Day 57

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

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

    The accumulation ratio for AUC0-28 = Day 57 AUC0-28 / Day 1 AUC0-28.

  9. Terminal Half-life (T1/2,z) of AMG 598 After Subcutaneous Injection on Day 57

    Time frame: Day 57 predose and days 62, 64, 71, 85, 99, 113, 127, 169, and 207

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

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study title

A Phase 1b, Randomized, Double-blind, Placebo-controlled, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 598 in Subjects With Obesity

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Nov 28, 2018
Registry last updated
Sep 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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