Clinical trial NCT06352892: A Study to Evaluate AMG 133 in Chinese Participants With Obesity or Overweight
Official title: A Phase 1, Open-label, Randomized, Parallel-group, Single-dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of AMG 133 Administered Subcutaneously in Chinese Subjects With Obesity or Overweight
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Obesity
Keywords: Obesity
Overweight
AMG 133
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2024-04-08
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main objective of the study is to assess the pharmacokinetics (PK) of Maridebart Cafraglutide after a single subcutaneous (SC) administration in overweight or obese Chinese participants.


Eligibility criteria: Inclusion Criteria:

* Provide signed informed consent.
* Participants must be of Chinese ancestry with biological parents and all 4 grandparents of Chinese ancestry.
* Male or female participants, between 18 and 65 years of age (inclusive) at the time of Screening. Female participants must be of nonchildbearing potential.
* Except for obesity, no clinically significant findings from medical history (that requires the use of medications and/or treatment), physical examination, 12-lead electrocardiogram (ECG), vital signs measurements, and clinical laboratory evaluations.
* Body mass index between 24 and 40 kg/m\^2 (inclusive) at the time of Screening.
* Have a stable body weight (\<5 kg self-reported change) within 3 months before Screening.
* Have not modified diet or adopted any nutritional lifestyle modification for 3 months.

Exclusion Criteria:

* History or evidence, at Screening or Check-in, of clinically significant disorder, condition, or disease not otherwise excluded that, in the opinion of the Investigator (or designee), would pose a risk to participant safety or interfere with the study evaluation, procedures, or completion.
* History or evidence, at Screening, of diabetes (regardless of type), based on Hemoglobin A1C of \> 7%.
* History or evidence of endocrine disorder (such as Cushing's Syndrome) that can cause obesity.
* Previous surgical procedure for obesity (excluding liposuction if performed \>1 year before study entry) within past 6 months from Check-in.
* History or current signs or symptoms of cardiovascular disease.
* History of clinically significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator (or designee) and in consultation with the Sponsor.
* Estimated glomerular filtration rate less than at least 60 mL/min/1.73 m\^2 at Screening or Check-in.
* Alanine aminotransferase or aspartate aminotransferase \>2 x the upper limit of normal at Screening or Check-in.
* Positive hepatitis B or hepatitis C panel and/or positive human immunodeficiency virus test at Screening. Participants whose results are compatible with prior immunity (vaccination or prior infection) may be included.
* Use of any over-the-counter or prescription medications within 30 days or 5 half-lives (whichever is longer) before Check-in.

  1. Acetaminophen (paracetamol; up to 2 g per day) for analgesia will be allowed.
  2. Hormone replacement therapy (eg, estrogen, thyroid) will be allowed.
* Current or prior use of any glucagon-like peptide 1 agonist within the past 3 months prior to Check-in.
* All herbal medicines (eg, St. John's wort), Traditional Chinese Medicine herbs or formulations, vitamins, and supplements consumed by the participant within the 30 days prior to enrollment, unless deemed acceptable by the Investigator (or designee) and in consultation with the Sponsor.
* History of alcoholism or regular alcohol consumption of \>14 units per week for males and \>7 units for females or drug/chemical abuse within 1 year prior to Check-in.
* Alcohol consumption from 48 hours prior to Check-in and is unwilling to limit alcohol intake to a maximum of 1 unit/day on all other days, while not in the clinical research unit, from Screening through the End of Study (EOS) visit.
* Use of tobacco- or nicotine-containing products within 6 months prior to Check-in.
* Female participants with a positive pregnancy test at Screening or Check-in.
* Female participants lactating/breastfeeding or who plans to breastfeed during the study through 90 days after the EOS visit.
* Unwilling to adhere to contraceptive requirements through 90 days after the EOS visit.
* Male participants with a female partner of childbearing potential and not willing to inform his partner of his participation in this clinical study.
* Pregnant partner (of a male participant) or partner planning to become pregnant who is unwilling to practice abstinence (refrain from heterosexual intercourse) or use contraception while the participant is on study through 90 days after the EOS visit.
* Participant has received a dose of an investigational drug within the past 90 days or 5 half-lives, whichever is longer, prior to Check-in.
* Have previously completed or withdrawn from this study or any other study investigating Maridebart Cafraglutide or have previously received the investigational product.

Primary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax) of Maridebart Cafraglutide
timeFrame: Up to approximately 120 days
measure: Area Under the Plasma Concentration-time Curve (AUC) from Time Zero to the Last Quantifiable Concentration (AUClast) of Maridebart Cafraglutide
timeFrame: Up to approximately 120 days
measure: AUC from Time Zero Extrapolated to Infinity (AUCinf) of Maridebart Cafraglutide
timeFrame: Up to approximately 120 days
Secondary outcomes:
measure: Number of Participants with Treatment-emergent Adverse Events
timeFrame: Up to approximately 120 days
measure: Number of Participants with Serious Adverse Events
timeFrame: Up to approximately 120 days
measure: Number of Participants with Anti-Maridebart Cafraglutide Antibodies
timeFrame: Up to approximately 120 days
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: