A Trial to Assess Bioavailability of AMG 133 in Participants With Overweight or Obesity

NCT07717814
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Phase
Phase 1
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Recruitment status
Completed
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Participants
154
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Lead sponsor
Amgen
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Start date
2024-11-26
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Number of sites
4
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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.
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Short title
A Trial to Assess Bioavailability of AMG 133 in Participants With Overweight or Obesity
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Official title
A Phase 1, Randomized, Open-label, Single-dose, Parallel Group Study to Assess the Relative Bioavailability of AMG 133 Administered Using One of Three Drug Products in Participants Living With Overweight or Obesity
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Control arm
Open label
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Completed
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Phase
Phase 1
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Study type
Interventional
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Completion date
2025-06-02
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First posted
2026-07-21
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Registry last updated
2026-07-21
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Primary completion date
2025-05-22
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Start date
2024-11-26
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Actual participants
154
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Participants
154
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Participant count basis
Actual
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Protocol amendments
0
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Number of sites
4
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
Amgen
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Source registry
ClinicalTrials.gov
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Registry ID
NCT07717814
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ClinicalTrials.gov ID
NCT07717814
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
No masking
Sources for study design
clinicaltrials.gov

  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

    Timeframe: Up to Day 120

  1. Number of Participants who Experienced Treatment-emergent Adverse Events (TEAEs)

    Timeframe: Day 1 to Day 120

  2. Number of Participants who Experienced Serious AEs (SAEs)

    Timeframe: Screening to Day 120 (up to 148 days)

  3. Number of Participants with Positive Anti-AMG 133 Antibody Formation

    Timeframe: Up to Day 120

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Maximum age
65 Years
Healthy volunteers
Yes

  1. Provide signed and dated informed consent before any study procedures.
  2. Be male or female, 18 to 65 years old, at screening.
  3. 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.
  4. Body mass index (BMI) between 25 and 40 kg/m² at screening.
  5. Stable body weight (less than 5 kg change by self-report) during the 3 months before screening.
  6. No major changes in diet or lifestyle (such as new weight-loss or exercise programs) during the past 3 months.

  1. Any significant medical condition or abnormal test result that could increase risk or interfere with study participation, based on investigator judgment.

  2. Diabetes (any type except past gestational diabetes) or Hemoglobin A1c (HbA1c) ≥ 6.5%.

  3. Endocrine disorders that can cause obesity (for example, Cushing's syndrome).

  4. Pancreatitis within the past year, or abnormal pancreatic blood tests (lipase/amylase > 2 × normal) or fasting triglycerides > 500 mg/dL.

  5. Cancer within 5 years (except treated non-melanoma skin cancer or in-situ cervical/breast lesions).

  6. Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2.

  7. 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.

  8. History or current signs of gastroparesis (delayed stomach emptying).

  9. Weight-loss surgery within 6 months before check-in.

  10. Heart or blood-vessel disease (aside from controlled high blood pressure or cholesterol), such as heart attack, angina, valve disease, or prior bypass/stent.

  11. Clinically significant abnormal heart rhythm on electrocardiogram (ECG) at screening or check-in.

  12. QT corrected for heart rate using Fridericia's method (QTcF) > 450 ms (males) or > 470 ms (females), or a history of long QT syndrome.

  13. Second- or third-degree heart block.

  14. Blood pressure > 150/95 mmHg or < 90/50 mmHg, or pulse > 110 bpm. A single repeat is allowed if values normalize.

  15. Allergy or hypersensitivity to AMG 133 or its ingredients.

  16. Poor veins for blood draws.

  17. Kidney function (estimated glomerular filtration rate [eGFR]) ≤ 60 mL/min/1.73 m^2.

  18. Liver enzymes (alanine aminotransferase [ALT] or aspartate aminotransferase [AST]) > 2X normal.

  19. Positive test for hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) (exceptions apply for prior vaccination or resolved hepatitis B virus [HBV] infection).

  20. Current or recent (within 6 months) suicidal thoughts, suicide attempts, or major psychiatric illness, including depression.

  21. Use of any prescription or over-the-counter medicines within 30 days or 5 half-lives (whichever is longer) before check-in, except:

    • Acetaminophen ≤ 2 g/day for pain
    • Hormone replacement (e.g., estrogen, thyroid) or hormonal contraception
    • Stable treatments (≥ 3 months) for high blood pressure, high cholesterol, or other mild, well-controlled conditions approved by the investigator and medical monitor.

  22. Use of any glucagon-like peptide-1 (GLP-1) or glucose-dependent insulinotropic polypeptide (GIP) receptor agonist/antagonist within 3 months.

  23. Use of herbal medicines, vitamins, or supplements within 30 days, unless approved by the investigator and sponsor.

  24. Consumption of poppy-seed-containing foods within 7 days before check-in.

  25. Alcohol abuse or regular intake > 21 units/week (men) or > 14 units/week (women), or drug abuse within 1 year. (1 unit = 12 oz beer, 1.5 oz liquor, 5 oz wine.)

  26. Alcohol use within 48 hours before check-in, or unwillingness to limit alcohol to ≤ 1 unit/day from discharge through study end.

  27. Strenuous exercise or a new exercise program within 7 days before check-in.

  28. Positive drug screen or tetrahydrocannabinol (THC) test, or unwillingness to avoid illicit drugs/THC through end of study.

  29. Positive pregnancy test at screening or check-in.

  30. Breastfeeding, or planning to breastfeed within 16 weeks after receiving AMG 133.

  31. Men and women unwilling to use required contraception through 16 weeks after receiving AMG 133.

  32. Men unwilling to abstain from sperm donation or women unwilling to abstain from egg donation through 16 weeks after receiving AMG 133.

  33. Men with female partners of childbearing potential unwilling to inform their partner and adhere to contraception requirements.

  34. Men with pregnant partners (or partners planning pregnancy) unwilling to use effective contraception or abstain from intercourse through 16 weeks after receiving AMG 133.

  35. Participation in another investigational drug study within 30 days or 5 half-lives (whichever is longer).

  36. Previous participation in any study of AMG 133.

  37. Blood donation within 3 months, plasma within 2 weeks, or platelets within 6 weeks before check-in.

  38. Unwillingness to follow study requirements or restrictions.

  39. Any other reason, in the investigator's opinion, that makes participation unsuitable.

Sources for eligibility
clinicaltrials.gov

  • Anaheim Clinical TrialsAnaheim, United States
  • Fortrea Clinical Research Unit - Daytona BeachDaytona Beach, United States
  • Fortrea Clinical Research Unit - DallasDallas, United States
  • Fortrea Clinical Research Unit Inc. - MadisonMadison, United States
Sources for sites
clinicaltrials.gov

Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (1)