CompletedPhase 1

A Trial to Evaluate Interactions Between Antiemetic Medication and AMG 133 in Participants Living With Overweight or Obesity

United States59 participantsStarted 2024-12-10

Plain-language summary

The primary objective of this trial is to evaluate the pharmacokinetics (PK) of AMG 133 administered alone and in combination with an antiemetic medication, ondansetron, in participants living with overweight or obesity.

Who can participate

Age range18 Years – 65 Years

SexALL

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

✓. Male or female participants, between 18 and 65 years of age.
✓. Body mass index \> 25 kg/m\^2.

Exclusion criteria

✕. History or evidence of clinically significant disorder, condition, or disease not otherwise excluded that, in the opinion of the Investigator, would pose a risk to participant safety or interfere with the trial evaluation, procedures, or completion.
✕. History of or active diabetes or hemoglobin A1C \> 6.5%.
✕. History or evidence of endocrine disorder.
✕. History of acute or chronic pancreatitis within 1 year, or elevation in serum lipase/amylase (\> 2 x upper limit of normal \[ULN\]), or fasting serum triglyceride level of \> 500 mg/dL.
✕. Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2.
✕. Uncontrolled thyroid disease.
✕. History or current signs or symptoms of cardiovascular disease.
✕. A QT interval corrected for heart rate based on the Fridericia's method (QTcF) interval \> 450 msec in male participants or \> 470 msec in female participants or history/evidence of long QT syndrome.

What they're measuring

Maximum Observed Plasma Concentration (Cmax) of AMG 133

Timeframe: Up to Day 120

Area Under the Plasma Concentration-time Curve (AUC) from Time Zero to Time of Last Quantifiable Concentration (AUClast) of AMG 133

Timeframe: Up to Day 120

AUC from Time Zero to Infinity (AUCinf) of AMG 133

Timeframe: Up to Day 120

Trial details

NCT IDNCT07310563

SponsorAmgen

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-05-09

View on ClinicalTrials.gov More Overweight trials

Who can participate

Age range18 Years – 65 Years

SexALL

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

✓. Male or female participants, between 18 and 65 years of age.
✓. Body mass index \> 25 kg/m\^2.

Exclusion criteria

✕. History or evidence of clinically significant disorder, condition, or disease not otherwise excluded that, in the opinion of the Investigator, would pose a risk to participant safety or interfere with the trial evaluation, procedures, or completion.
✕. History of or active diabetes or hemoglobin A1C \> 6.5%.
✕. History or evidence of endocrine disorder.
✕. History of acute or chronic pancreatitis within 1 year, or elevation in serum lipase/amylase (\> 2 x upper limit of normal \[ULN\]), or fasting serum triglyceride level of \> 500 mg/dL.
✕. Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2.
✕. Uncontrolled thyroid disease.
✕. History or current signs or symptoms of cardiovascular disease.
✕. A QT interval corrected for heart rate based on the Fridericia's method (QTcF) interval \> 450 msec in male participants or \> 470 msec in female participants or history/evidence of long QT syndrome.

What they're measuring

Maximum Observed Plasma Concentration (Cmax) of AMG 133

Timeframe: Up to Day 120

Area Under the Plasma Concentration-time Curve (AUC) from Time Zero to Time of Last Quantifiable Concentration (AUClast) of AMG 133

Timeframe: Up to Day 120

AUC from Time Zero to Infinity (AUCinf) of AMG 133

Timeframe: Up to Day 120