Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AMG 598 · 1 trial · 1 indication
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.
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).
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for a total of 3 doses. |
| Placebo + Liraglutide | ACTIVE_COMPARATOR | 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. |
| AMG 598 70 mg | EXPERIMENTAL | Participants received 70 mg AMG 598 by subcutaneous injection once every 4 weeks (Q4W) for a total of 3 doses. |
| AMG 598 70 mg + Liraglutide | EXPERIMENTAL | 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. |
| AMG 598 210 mg | EXPERIMENTAL | Participants received 210 mg AMG 598 by subcutaneous injection once every 4 weeks for a total of 3 doses. |
| AMG 598 210 mg + Liraglutide | EXPERIMENTAL | 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. |
| AMG 598 420 mg | EXPERIMENTAL | Participants received 420 mg AMG 598 by subcutaneous injection once every 4 weeks for a total of 3 doses. |
| AMG 598 420 mg + Liraglutide | EXPERIMENTAL | 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. |
| Name | Type | Description |
|---|---|---|
| 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. |
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 ...
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AMG 598 is an investigational small molecule being developed for the treatment of obesity. It is intended for adults with obesity, as studied in a clinical trial that enrolled participants aged 18 years and older. The drug is currently in Phase 1 clinical development and has not been approved by regulatory authorities.
AMG 598 is being developed by Amgen Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol AMGN. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug for the treatment of obesity.
AMG 598 is in Phase 1 clinical development. A Phase 1 trial has been completed, which was a multiple ascending dose study in adults with obesity. The drug is investigational and has not yet received regulatory approval for any use.
AMG 598 has one completed clinical trial, identified as NCT03757130, titled "Multiple Ascending Dose Study of AMG 598 in Adults With Obesity." This Phase 1 trial enrolled 50 participants in the United States and was a randomized, double-blind, placebo-controlled study.
AMG 598 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for the treatment of obesity. The completed Phase 1 trial was designed to evaluate the drug's safety and tolerability, but further studies are needed before any regulatory approval can be considered.