Phase 1
Completed N=50
Multiple Ascending Dose Study of AMG 598 in Adults With Obesity
Source: ClinicalTrials.gov NCT03757130 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Sep 2023
Primary outcomePrimary: Number of Participants With Treatment-emergent Adverse Events — 1; 6; 4; 7 Participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment-emergent Adverse Events |
1; 6; 4; 7; 5; 6 | — |
| PRIMARY Number of Participants With TEAEs Due to Laboratory, Electrocardiogram, and Vital Sign Findings |
0; 0; 0; 0; 1; 0 | — |
| SECONDARY Maximum Observed Concentration (Cmax) of AMG 598 After Subcutaneous Injection on Day 1 and Day 57 |
5.83; 7.49; 21.5; 18.0; 51.1; 36.9 | — |
| SECONDARY Time to Maximum Observed Concentration (Tmax) of AMG 598 After Subcutaneous Injection on Day 1 and Day 57 |
7.1; 7.0; 7.1; 7.0; 6.9; 7.0 | — |
| SECONDARY Dose-normalized Cmax of AMG 598 After Subcutaneous Injection on Day 1 and Day 57 |
0.0833; 0.107; 0.102; 0.0856; 0.122; 0.0879 | — |
| SECONDARY 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 |
139; 147; 495; 366; 1080; 763 | — |
| SECONDARY Dose-normalized AUC0-28 for AMG 598 After Subcutaneous Injection on Day 1 and Day 57 |
1.98; 2.10; 2.36; 1.74; 2.57; 1.82 | — |
| SECONDARY 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 |
458; 612; 2130; 1570; 4060; 3060 | — |
| SECONDARY Accumulation Ratio (AR) for Cmax of AMG 598 After Subcutaneous Injection on Day 1 and Day 57 |
1.62; 1.70; 2.12; 1.92; 1.83; 2.13 | — |
| SECONDARY Accumulation Ratio of AUC0-28 for AMG 598 After Subcutaneous Injection on Day 1 and Day 57 |
1.74; 1.84; 2.09; 1.86; 1.96; 2.17 | — |
| SECONDARY Terminal Half-life (T1/2,z) of AMG 598 After Subcutaneous Injection on Day 57 |
28.2; 31.5; 35.2; 29.1; 35.8; 29.8 | — |
Eligibility 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/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
Data sourced from ClinicalTrials.gov (NCT03757130). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.