Effect of Maridebart Cafraglutide on the Heart's Electrical Activity

NCT07229157 | Active Not Recruiting Phase 1 FDA Drug

• 1 other identifier: 20250003
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 2

Brief Summary

The main objective of this trial is to evaluate the effect of maridebart cafraglutide subcutaneously (SC) on the placebo-corrected, change from baseline in QT interval corrected for heart rate using Fridericia's formula in participants living with overweight or obesity.

Conditions

Overweight; Obesity

Keywords

Overweight; Obesity; Maridebart Cafraglutide; AMG 133; QT/QTc Intervals

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in QTcF for Maridebart Cafraglutide

  Change from baseline in QTcF for maridebart cafraglutide will be the dependent variable for calculation of model-derived placebo-corrected, change from baseline in QTcF after maridebart cafraglutide dosing.

  Up to Day 171

Secondary Outcomes (13)

• Area Under the Concentration-time Curve Over the Dosing Interval (AUCtau) of Maridebart Cafraglutide

  Up to Day 171

• Maximum Observed Concentration (Cmax) of Maridebart Cafraglutide

  Up to Day 171

• Change from Baseline in Heart Rate

  Up to Day 171

• Change from Baseline in PR Interval

  Up to Day 171

• Change from Baseline in QRS Duration

  Up to Day 171

Study Arms (3)

Group 1

EXPERIMENTAL

In treatment period 1, participants will receive placebo for moxifloxacin. In treatment period 2, participants will receive maridebart cafraglutide. In treatment period 3, participants will receive placebo for moxifloxacin.

Drug: Maridebart Cafraglutide; Drug: Placebo for Moxifloxacin

Group 2A

EXPERIMENTAL

In treatment period 1, participants will receive moxifloxacin. In treatment period 2, participants will receive placebo for maridebart cafraglutide. In treatment period 3, participants will receive placebo for moxifloxacin.

Drug: Moxifloxacin; Drug: Placebo for Maridebart Cafraglutide; Drug: Placebo for Moxifloxacin

Group 2B

EXPERIMENTAL

In treatment period 1, participants will receive placebo for moxifloxacin. In treatment period 2, participants will receive placebo for maridebart cafraglutide. In treatment period 3, participants will receive moxifloxacin.

Drug: Moxifloxacin; Drug: Placebo for Maridebart Cafraglutide; Drug: Placebo for Moxifloxacin

Interventions

Moxifloxacin DRUG

Participants will receive moxifloxacin orally.

Group 2A; Group 2B

Maridebart Cafraglutide DRUG

Participants will receive maridebart cafraglutide SC.

Also known as: AMG 133

Group 1

Placebo for Maridebart Cafraglutide DRUG

Participants will receive placebo for maridebart cafraglutide SC.

Group 2A; Group 2B

Placebo for Moxifloxacin DRUG

Participants will receive placebo for moxifloxacin orally.

Group 1; Group 2A; Group 2B

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• To take part in the trial, participants must meet all of the following:
• Provide signed and dated informed consent before any trial procedures.
• Be able to understand the trial requirements, sign the consent form, and follow trial restrictions.
• Male or female, of any race, between 18 and 60 years old (inclusive).
• Females must not be pregnant or breastfeeding.
• Males and females who could become pregnant must agree to use effective birth control as specified in the protocol.
• Body mass index (BMI) between 25.0 and 35.0 kg/m\^2 (inclusive).
• No major changes in diet or lifestyle in the past 3 months, based on self-report.
• Stable body weight (less than 5 kg change) in the past 3 months, based on self-report.
• Blood potassium, calcium, and magnesium within the normal range at screening and at check-in for the first treatment period.
• Participants with controlled high blood pressure, cholesterol problems, or hypothyroidism on stable treatment for at least 3 months may be included (except for medicines known to affect heart rhythm or interact with moxifloxacin). Other mild, stable health conditions may be allowed with approval from the investigator and medical monitor.

You may not qualify if:

• Participants will not be able to take part if they meet any of the following:
• Medical Conditions
• Any significant medical condition or abnormal test result that, in the opinion of the investigator, could pose a risk or interfere with trial participation.
• History of diabetes (any type, except past gestational diabetes), or Haemoglobin A1c (HbA1c) ≥ 6.5% at screening.
• History of pancreatitis within the past year, or high blood tests suggesting pancreatic problems (lipase/amylase \> 2× normal, or fasting triglycerides \> 500 mg/dL).
• Liver enzymes (alanine aminotransferase \[ALT\] or aspartate aminotransferase \[AST\]) more than 2× the upper limit of normal.
• Kidney function (estimated glomerular filtration rate \[eGFR\]) \< 70 mL/min/1.73 m\^2.
• Cancer within the last 5 years (except treated nonmelanoma skin cancers or in situ cervical/breast lesions).
• Personal or family history of medullary thyroid cancer or multiple endocrine neoplasia type 2.
• Uncontrolled thyroid disease (abnormal thyroid-stimulating hormone \[TSH\] outside 0.4-6.0 mIU/L).
• Contraindications to moxifloxacin, including history of tendon disorders with quinolone use.
• History of gastrointestinal surgery or disease that may affect absorption of oral drugs (other than uncomplicated appendectomy or hernia repair).
• Inability to swallow pills.
• History of significant esophageal, stomach, or bowel disorders (eg, ulcers, bleeding, Crohn's disease, ulcerative colitis, irritable bowel syndrome, gastroparesis).
• Current or recent suicidal thoughts (per Columbia Suicide Severity Rating Scale \[C-SSRS\]).

Sponsors & Collaborators

• Amgen: lead

Study Sites (2)

Fortrea Clinical Research Unit - Daytona Beach

Daytona Beach, Florida, 32117-5116, United States

Location

Fortrea Clinical Research Unit - Dallas

Dallas, Texas, 75247-4968, United States

Location

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Overweight; Obesity

Interventions

Moxifloxacin

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2025
• First Posted: November 14, 2025
• Study Start: October 22, 2025
• Primary Completion (Estimated): August 26, 2026
• Study Completion (Estimated): August 26, 2026
• Last Updated: January 23, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe, or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
• Access Criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.

Locations

US (2)