First-in-human Study of the Safety, Tolerability, Pharmacokinetics, and Food Effect of ACCG-2671
Start Date
12/29/2025
Completion Date
4/1/2027
Summary
This first-in-human study will evaluate the safety, tolerability, and pharmacokinetics of single and multiple ascending oral doses of ACCG-2671. It will also evaluate the effect of food on the pharmacokinetics, safety, and tolerability of a single dose. Parts 1 and 2 will enroll healthy participants, and Part 3 will enroll otherwise healthy participants with obesity.
Detailed Description
ACCG-2671 is a nonpeptide dual amylin and calcitonin receptor agonist (DACRA) This study comprises 3 parts: Part 1 (Single Ascending Dose \[SAD\]) will be conducted in healthy participants to assess the safety, tolerability, and PK profile of a single oral dose of ACCG-2671 or -matched placebo (SAD Cohorts 1 through 5). Part 2 (Food Effect) will be conducted in healthy participants to assess the effect of food intake on the PK, safety, and tolerability of a single oral dose of ACCG-2671 under fasted and fed conditions. Part 3 (Multiple Ascending Dose \[MAD\]) will be conducted in otherwise healthy, participants with obesity (BMI ≥ 30 kg/m2) to assess the safety, tolerability, PK profiles of ACCG-2671 or matched placebo administered for 84 days (MAD Cohorts 1 through 5) Safety Review Committee (SRC) meetings will be held prior to dose escalation for Part 1 (SAD) and Part 3 (MAD) cohorts in the study. The decisions on dose escalation will be based on safety and laboratory data and available PK data from each cohort.
Eligibility Criteria
Age Range: 25 years to 75 years
Interventions
ACCG-2671
Placebo
Conditions
Locations
Research Site
Cypress, California 90630
United States
Research Site
Lake Forest, California 92630
United States
Research Site
Decatur, Georgia 30030
United States
Research Site
Dilworth, Minnesota 56529
United States
Research Site
Springfield, Missouri 65802
United States
Research Site
Webster, Texas 77598
United States