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Study Complete
Sponsor ID
20170139

Multiple Ascending Dose Study of AMG 598 in Subjects with Obesity

Sponsor ID
20170139
Clinicaltrials.gov ID
NCT03757130
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

This is a randomized, double-blind, placebo-controlled, multiple ascending dose study in subjects with obesity. AMG 598 will be evaluated in approximately 108 subjects to assess safety, tolerability, pharmacokinetics and pharmacodynamic effects.

Additional Study Details

Phase
Phase 1
Product
AMG 598
Type
Interventional
Masking
Double (Participant, Investigator)
Enrollment
50
Additional Study Details

Protocol Summary

Primary Outcome Measures

Subject incidence of treatment-emergent adverse events

Timeframe: up to 263 days

Secondary Outcome Measures

Pharmacokinetics parameter of maximum observed concentration (Cmax)

Timeframe: up to 263 days

Pharmacokinetics parameter of time of maximum observed concentration (tmax)

Timeframe: up to 263 days

Pharmacokinetics parameter of area under the concentration time curve (AUC)

Timeframe: up to 263 days

Locations

Location
Status
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Location
QPS Miami Research Associates
South Miami, FL, United States, 33143
Status
Completed
Location
Orange County Research Center
Tustin, CA, United States, 92780
Status
Completed
Location
Dallas Diabetes and Endocrine Center
Dallas, TX, United States, 75230
Status
Terminated
Location
William D Summers MD LLC
Birmingham, AL, United States, 35235
Status
Terminated
Study Info
Age
18 - 65 Years
Condition
  • Weight Loss & Obesity
    • Sex
    All
    Trial Dates
    Nov 2018 - Dec 2019
    Inclusion and Exclusion Criteria
    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/m2 and less than or equal to 40.0 kg/m2 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