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

ClinicalTrials.gov ID

NCT07815678

Lead Sponsor

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

Overall Status

Recruiting

Study Type

Interventional

Phase

Phase 1Phase 2

Enrollment

164Estimated

Last Update Posted

Sep 11, 2026Actual

Start Date

Dec 29, 2025Actual

Primary Completion Date

Mar 2027Estimated

Completion Date

Apr 2027Estimated

Official Title

A Randomized, Double-blind, Placebo-controlled, First-in-human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Food-effect of ACCG-2671

Brief 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.

• Obesity

• ACCG-2671
• Placebo

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

Yes

Eligibility Criteria

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.

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

Triple

Lead Sponsor

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

ACCGClinicalTrials@Structuretx.com650-457-1959

ACCGClinicalTrials@Structuretx.com650-457-1959

ACCGClinicalTrials@Structuretx.com650-457-1959

ACCGClinicalTrials@Structuretx.com650-457-1959

ACCGClinicalTrials@Structuretx.com650-457-1959

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