Multiple Ascending Dose Study of AMG 598 in Adults With Obesity

Status

Completed

Phase

Phase 1

Enrollment

50 participants (actual)

Sponsor

Amgen · Industry

Design

Randomized · Double masking

Countries

1 country

United States

Start

26 Nov 2018

Primary completion

16 Dec 2019

Completion

16 Dec 2019

First posted

28 Nov 2018

Last update posted

14 Sept 2023

Conditions

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.

• Placebo comparator

  Placebo

  Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for a total of 3 doses.

• Active comparator

  Placebo + Liraglutide

  Participants received placebo subcutaneous injection once every 4 weeks for a total of 3 doses in addition to liraglutide administered by subcutaneous injection once a day for 12 weeks. The starting dose of liraglutide was 0.6 mg/day, increasing in increments of 0.6 mg/day every 7 days to reach the full dosage of 3 mg/day by week 5.

• Experimental

  AMG 598 70 mg

  Participants received 70 mg AMG 598 by subcutaneous injection once every 4 weeks (Q4W) for a total of 3 doses.

• Experimental

  AMG 598 70 mg + Liraglutide

  Participants received 70 mg AMG 598 by subcutaneous injection once every 4 weeks for a total of 3 doses in addition liraglutide administered by subcutaneous injection once a day for 12 weeks. The starting dose of liraglutide was 0.6 mg/day, increasing in increments of 0.6 mg/day every 7 days to reach the full dosage of 3 mg/day by week 5.

• Experimental

  AMG 598 210 mg

  Participants received 210 mg AMG 598 by subcutaneous injection once every 4 weeks for a total of 3 doses.

• Experimental

  AMG 598 210 mg + Liraglutide

  Participants received 210 mg AMG 598 by subcutaneous injection once every 4 weeks for a total of 3 doses in addition to liraglutide administered by subcutaneous injection once a day for 12 weeks. The starting dose of liraglutide was 0.6 mg/day, increasing in increments of 0.6 mg/day every 7 days to reach the full dosage of 3 mg/day by week 5.

• Experimental

  AMG 598 420 mg

  Participants received 420 mg AMG 598 by subcutaneous injection once every 4 weeks for a total of 3 doses.

• Experimental

  AMG 598 420 mg + Liraglutide

  Participants received 420 mg AMG 598 by subcutaneous injection once every 4 weeks for a total of 3 doses in addition to liraglutide administered by subcutaneous injection once a day for 12 weeks. The starting dose of liraglutide was 0.6 mg/day, increasing in increments of 0.6 mg/day every 7 days to reach the full dosage of 3 mg/day by week 5.

1. Number of Participants With Treatment-emergent Adverse Events

   Time frame · 207 days

   Registry description

   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

   Registry description

   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).

No study cites this trial.