Multiple Ascending Dose Study of AMG 598 in Adults With Obesity

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Amgen
Study ID
NCT03757130
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Nov 26, 2018
Status verified
Nov 2022
Primary completion
Dec 16, 2019
Completion
Dec 16, 2019

Study Design

Enrollment
50 participants (actual)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
OTHER

Arms

  • 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.

Primary Outcome Measure

Number of Participants With Treatment-emergent Adverse Events [ Time Frame: 207 days ]

Locations (4)

FacilityCityStateZIPSite coordinators
William D Summers MD LLCBirminghamAlabama35235-
Orange County Research CenterTustinCalifornia92780-
QPS Miami Research AssociatesSouth MiamiFlorida33143-
Dallas Diabetes and Endocrine CenterDallasTexas75230-

Find similar trials in Birmingham, AL

By condition
Obesity / overweight
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
William D Summers MD LLC· Birmingham, ALOrange County Research Center· Tustin, CAQPS Miami Research Associates· South Miami, FLDallas Diabetes and Endocrine Center· Dallas, TX

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