A Trial to Assess Bioavailability of AMG 133 in Participants With Overweight or Obesity (NCT07717814) | Clinical Trial Compass
CompletedPhase 1
A Trial to Assess Bioavailability of AMG 133 in Participants With Overweight or Obesity
United States154 participantsStarted 2024-11-26
Plain-language summary
The primary objective of the trial is to evaluate the pharmacokinetics (PK) of AMG 133 administered as a single subcutaneous (SC) dose using a liquid drug product in vial compared to a frozen liquid drug product in vial in participants living with overweight or obesity.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Provide signed and dated informed consent before any study procedures.
. Be male or female, 18 to 65 years old, at screening.
. May have well-controlled conditions such as obstructive sleep apnea, high blood pressure, high cholesterol, or hypothyroidism on stable treatment for ≥ 3 months. Other mild, stable health conditions may be allowed with investigator and medical monitor approval.
. Body mass index (BMI) between 25 and 40 kg/m² at screening.
. Stable body weight (less than 5 kg change by self-report) during the 3 months before screening.
. No major changes in diet or lifestyle (such as new weight-loss or exercise programs) during the past 3 months.
Exclusion criteria
. Any significant medical condition or abnormal test result that could increase risk or interfere with study participation, based on investigator judgment.
. Diabetes (any type except past gestational diabetes) or Hemoglobin A1c (HbA1c) ≥ 6.5%.
. Endocrine disorders that can cause obesity (for example, Cushing's syndrome).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Maximum Observed Concentration (Cmax) of AMG 133
Timeframe: Up to Day 120
2
Area Under the Concentration-time Curve (AUC) From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of AMG 133
Timeframe: Up to Day 120
3
AUC From Time 0 Extrapolated to Infinity (AUCinf) of AMG 133
. Pancreatitis within the past year, or abnormal pancreatic blood tests (lipase/amylase \> 2 × normal) or fasting triglycerides \> 500 mg/dL.
. Cancer within 5 years (except treated non-melanoma skin cancer or in-situ cervical/breast lesions).
. Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2.
. Uncontrolled thyroid disease (thyroid stimulating hormone \[TSH\] \> 6.0 or \< 0.4 mIU/L). Participants on stable thyroid-replacement therapy for ≥ 3 months may be included if TSH is in range.
. History or current signs of gastroparesis (delayed stomach emptying).