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

Amgen

Status and phase: Completed; Phase 1

Conditions: Overweight; Obesity

Treatments: Drug: AMG 133; Drug: Ondansetron

Study type: Interventional

Funder types: Industry

Identifiers

NCT07310563

20210281

Details and patient eligibility

About

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.

Enrollment: 59 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

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

Exclusion Criteria

1. 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.
2. History of or active diabetes or hemoglobin A1C > 6.5%.
3. History or evidence of endocrine disorder.
4. 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.
5. Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2.
6. Uncontrolled thyroid disease.
7. History or current signs or symptoms of cardiovascular disease.
8. 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.
9. History of hypersensitivity, intolerance, or allergy to AMG 133 or its ingredients.
10. Any contraindication to ondansetron ODT according to the applicable labelling.
11. Alanine aminotransferase or aspartate aminotransferase > 2 x the ULN.
12. Use of any over-the-counter or prescription medications within 30 days or 5 half-lives (whichever is longer) before check-in.
13. Current use or prior use of any glucagon-like peptide 1 receptor (GLP-1R) agonist, or glucose-dependent insulinotropic polypeptide receptor (GIPR) agonist or antagonist within the past 3 months.
14. Participant has received a dose of an investigational medicinal product (IMP) within the past 30 days or 5 half-lives.
15. Have previously completed or withdrawn from this trial or any other trial investigating AMG 133 or have previously received the IMP.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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59 participants in 4 patient groups

Low Dose AMG 133 without Ondansetron

Experimental group

Description:

Participants will receive a single subcutaneous (SC) low dose of 70 mg AMG 133.

Treatment:

Drug: AMG 133

High Dose AMG 133 without Ondansetron

Experimental group

Description:

Participants will receive a single SC high dose of 350 mg AMG 133.

Treatment:

Drug: AMG 133

Low Dose AMG 133 with Ondansetron

Experimental group

Description:

Participants will receive a single SC low dose of 70 mg AMG 133 and ondansetron 8 mg orally disintegrating tablet (ODT) every 8 hours for 72 hours.

Treatment:

Drug: Ondansetron

Drug: AMG 133

High Dose AMG 133 with Ondansetron

Experimental group

Description:

Participants will receive a single SC high dose of 350 mg AMG 133 and ondansetron 8mg ODT every 8 hours for 72 hours.

Treatment:

Drug: Ondansetron

Drug: AMG 133