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Single and Multiple Ascending Dose Study to Evaluate AMG 786 in Healthy Participants and Participants With Obesity | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Single and Multiple Ascending Dose Study to Evaluate AMG 786 in Healthy Participants and Participants With Obesity

A Phase 1, Randomized, Double-blind, Placebo Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AMG 786 in Healthy Subjects and Subjects With Obesity

NCT05406115•Amgen

View on ClinicalTrials.gov

Summary

The primary objective of this study is to assess the safety and tolerability of AMG 786 as single or multiple doses in healthy and obese participants.

Detailed Description

The 4th Multiple Ascending Dose cohort was not started.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Participant has provided informed consent/assent prior to initiation of any study-specific activities/procedures
•Age 18 to 65 years at the time of signing the informed consent
•Female participants must be of non-childbearing potential (as described below)
•* Postmenopausal is defined as:
•Age of ≥ 55 years with no menses for at least 12 months; OR
•Age \< 55 years with no menses for at least 12 months AND with a follicle-stimulating hormone (FSH) level \> 40 IU/L or according to the definition of "postmenopausal range" for the laboratory involved; OR
•History of hysterectomy; OR
•History of bilateral oophorectomy
•Healthy as determined by the investigator or medically qualified designee based on a medical evaluation including medical history, physical examination, laboratory tests, and Electrocardiograms (ECGs) on day -1 (Part A) and day -1 (Part B) and screening
•Body Mass Index must be between 18 and \< 25 kg/m\^2 for healthy participants and between ≥ 25 and ≤ 32.0 kg/m\^2 for otherwise healthy participants with obesity
+2 more criteria

Exclusion Criteria

•Malignancy except non-melanoma skin cancers, cervical or breast ductal carcinoma in situ within the last 5 years
•History or clinical evidence of diabetes mellitus, including a fasting glucose ≥ 125 mg/dl (6.9 mmol/L) and/or HbA1c ≥ 6.5%
•Triglycerides ≥ 5.65 mmol/L (ie, 500 mg/dL) at screening
•Hepatic liver enzymes alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, or total bilirubin levels \> 1.5 times the upper limit of normal (ULN) at screening. Participants with suspected or diagnosed Gilbert's disease will be excluded from the study.
•History or clinical evidence of bleeding diathesis or any coagulation disorder, including prothrombin time (PT), activated partial thromboplastin time (APTT), International normalized ratio (INR) or platelet count outside of the laboratory's normal reference range unless interpreted as not clinically significant by the investigator in consultation with the medical monitor at screening.
•History of gastrointestinal (GI) abnormality that could affect GI motility (including small bowel or colonic resection, inflammatory bowel disease, irritable bowel disease, and colon or GI tract cancer)
•Untreated or uncontrolled hypothyroidism/hyperthyroidism defined as thyroid-stimulating hormone (TSH) value outside normal range
•A corrected QT interval at screening of \> 450 msec in males or \> 470 msec in females or history of long QT syndrome
•History of coronary artery disease or congestive heart failure
•Participants with a history of renal impairment or renal disease and/or estimated glomerular filtration rate (eGFR) ≤ 60 mL/min/1.73 m\^2
+9 more criteria

Locations (3)

Orange County Research Center

Tustin, California, United States

Translational Clinical Research LLC

Aventura, Florida, United States

Clinical Pharmacology of Miami, LLC

Miami, Florida, United States

Key Dates

Start Date

July 26, 2022

Primary Completion Date

August 21, 2023

Completion Date

August 21, 2023

Last Updated

October 27, 2025

Enrollment

ACTUAL participants

Conditions

Obesity

Interventions

AMG 786

DRUG

Placebo

OTHER

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 27, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Single and Multiple Ascending Dose Study to Evaluate AMG 786 in Healthy Participants and Participants With Obesity

Inclusion Criteria

Exclusion Criteria

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