Skip to main content
Back to Trials
NCT07815678PHASE1, PHASE2RecruitingAccepts Healthy Volunteers

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

Aconcagua Bio, Inc. a wholly owned subsidiary of Structure Therapeutics

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

Inclusion Criteria: * Signed informed consent * Men and women with the following at the time of Screening for Part 1 and 2: ≥25 years and ≤65 years of age and BMI ≥18.0 kg/m2 and \<30.0 kg/m2 * For Part 3, ≥25 years and ≤75 years of age and BMI ≥30.0 kg/m2 * For Part 3, receiving a stable dose of an injectable GLP-1RA for ≥3 months, who responded to GLP1RA treatment with stable body weight and no ongoing GLP-1RA-related symptoms or AEs. For the duration of the study, participants must not be planning to change GLP-1RA dose or discontinue GLP-1RA treatment * Body weight ≥50.0 kg at time of screening Exclusion Criteria: * For Parts 1 and Part 2: Participants with any clinically significant medical conditions are excluded from the study. * For Parts 1, 2 and 3: participants will be excluded from this study if there is evidence of ANY of the exclusion criteria at the Screening Visit or prior to first dose administration * History or presence of significant CV, pulmonary, hepatic, renal, hematological, GI, endocrine, immunologic, dermatologic, psychiatric, or neurological disease, including any acute illness or major surgery within the past 3 months, or any clinical laboratory abnormality determined by the Investigator to be clinically significant * Use of any prescription or over-the counter-medication including herbal products, diet aids, vitamins, or hormone supplements (including contraceptives) within 10 days or 5 times the apparent elimination half-life of the medication (whichever is longer) before the first study drug administration and throughout the study. Exceptions include injectable GLP-1RA treatment for Part 3, Cohort 2c only and medications used to manage AEs at the discretion of an investigator after consultation with the Sponsor.

Interventions

DRUG

ACCG-2671

DRUG

Placebo

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Obesity

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