First-in-human Study of the Safety, Tolerability, Pharmacokinetics, and Food Effect of ACCG-2671

Authors
Category Primary study
Registry of TrialsClinicalTrials.gov
Year 2026
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 assessthe safety, tolerability, and PK profile of a single oral dose of ACCG‐2671 or ‐matchedplacebo (SAD Cohorts 1 through 5).Part 2 (Food Effect) will be conducted in healthy participants to assess the effect offood intake on the PK, safety, and tolerability of a single oral dose of ACCG‐2671 underfasted 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, PKprofiles of ACCG‐2671 or matched placebo administered for 84 days (MAD Cohorts 1 through5)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 bebased on safety and laboratory data and available PK data from each cohort.
Epistemonikos ID: ec3eb72d5b5dfed5fba3d73269a3a816559e0afd
First added on: Sep 12, 2026