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

NCT07815678 | Recruiting Phase 1 FDA Drug

• 1 other identifier: ACCG-2671-01
• Study Type: interventional
• Target: 164
• Locations: 1 country
• Sites: 6

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.

Conditions

Obesity

Keywords

Obesity; Amylin; Structure Therapeutics; Intervention/Treatment; Drug: Placebo; DRUG:ACCG-2671

Outcome Measures

Primary Outcomes (40)

• Number of participants with one or more adverse events (AEs) as assessed by CTCAE v5.0

  Baseline to Day 17 (Part 1, Cohorts 1, 2, and 3); baseline to Day 24 (Part 1, Cohorts 4 and 5); baseline to Day 21 (Part 2); baseline to Day 112 (Part 3)

• Number of participants with one or more serious adverse advents (SAEs) as assessed by CTCAE v5.0

  Baseline to Day 17 (Part 1, Cohorts 1, 2, and 3); baseline to Day 24 (Part 1, Cohorts 4 and 5); baseline to Day 21 (Part 2); baseline to Day 112 (Part 3)

• Number of participants with one or more treatment-emergent adverse events (TEAEs) as assessed by CTCAE v5.0

  Baseline to Day 21 (Part 2)

• Change from baseline in systolic blood pressure

  Baseline to Day 15 (Part 1, Cohorts 1, 2, and 3); baseline to Day 22 (Part 1, Cohorts 4 and 5); baseline to Day 21 (Part 2); baseline to Day 112 (Part 3)

• Change from baseline in diastolic blood pressure

  Baseline to Day 15 (Part 1, Cohorts 1, 2, and 3); baseline to Day 22 (Part 1, Cohorts 4 and 5); baseline to Day 21 (Part 2); baseline to Day 112 (Part 3)

• Change from baseline in heart rate

  Baseline to Day 15 (Part 1, Cohorts 1, 2, and 3); baseline to Day 22 (Part 1, Cohorts 4 and 5); baseline to Day 21 (Part 2); baseline to Day 112 (Part 3)

• Change from baseline in ECG ventricular heart rate

  Baseline to Day 17 (Part 1, Cohorts 1, 2, and 3); baseline to Day 22 (Part 1, Cohorts 4 and 5); baseline to Day 21 (Part 2); predose to Day 70 (Part 3)

• Change from baseline in ECG PR interval

  Baseline to Day 17 (Part 1, Cohorts 1, 2, and 3); baseline to Day 22 (Part 1, Cohorts 4 and 5); baseline to Day 21 (Part 2); predose to Day 70 (Part 3)

• Change from baseline ECG QRS duration

  Baseline to Day 17 (Part 1, Cohorts 1, 2, and 3); baseline to Day 22 (Part 1, Cohorts 4 and 5); baseline to Day 21 (Part 2); predose to Day 70 (Part 3)

• Change from baseline in ECG QT Interval corrected using Fridericia's Formula (QTcF)

  Baseline to Day 17 (Part 1, Cohorts 1, 2, and 3); baseline to Day 22 (Part 1, Cohorts 4 and 5); baseline to Day 21 (Part 2); predose to Day 70 (Part 3)

• Change from baseline in hemoglobin

  Baseline to Day 17 (Part 1, Cohorts 1, 2, and 3); baseline to Day 22 (Part 1, Cohorts 4 and 5); baseline to Day 21 (Part 2); baseline to Day 112 (Part 3)

• Change from baseline in hematocrit

  Baseline to Day 17 (Part 1, Cohorts 1, 2, and 3); baseline to Day 22 (Part 1, Cohorts 4 and 5); baseline to Day 21 (Part 2); baseline to Day 112 (Part 3)

• Change from baseline in thrombocyte count (platelet count)

  Baseline to Day 17 (Part 1, Cohorts 1, 2, and 3); baseline to Day 22 (Part 1, Cohorts 4 and 5); baseline to Day 21 (Part 2); baseline to Day 112 (Part 3)

• Change from baseline in white blood cell (WBC) count

  Baseline to Day 17 (Part 1, Cohorts 1, 2, and 3); baseline to Day 22 (Part 1, Cohorts 4 and 5); baseline to Day 21 (Part 2); baseline to Day 112 (Part 3)

• Change from baseline in prothrombin time

  Baseline to day 17 (Part 1, Cohorts 1, 2, and 3); baseline to day 22 (Part 1, Cohorts 4 and 5); baseline to day 21 (Part 2); baseline to day 112 (Part 3)

• Change from baseline in international normalized ratio (INR)

  Baseline to day 17 (Part 1, Cohorts 1, 2 and 3); baseline to day 22 (Part 1 Cohorts 4 and 5); baseline to day 21 (Part 2); baseline to day 112 (Part 3)

• Change from baseline in activated partial thromboplastin time (aPTT)

  Baseline to day 17 (Part 1, Cohorts 1, 2 and 3); baseline to Day 22 (Part 1, Cohorts 4 and 5); baseline to Day 21 (Part 2); baseline to Day 112 (Part 3)

• Change from baseline in fibrinogen activity

  Baseline to Day 17 (Part 1, Cohorts 1, 2 and 3); baseline to Day 22 (Part 1, Cohorts 4 and 5); baseline to Day 21 (Part 2); baseline to Day 112 (Part 3)

• Change from baseline in sodium

  Baseline to Day 17 (Part 1, Cohorts 1, 2, and 3); baseline to Day 22 (Part 1, Cohorts 4 and 5); baseline to Day 21 (Part 2); baseline to Day 112 (Part 3)

• Change from baseline in potassium

  Baseline to Day 17 (Part 1, Cohorts 1, 2, and 3); baseline to Day 22 (Part 1, Cohorts 4 and 5); baseline to Day 21 (Part 2); baseline to Day 112 (Part 3)

• Change from baseline in chloride

  Baseline to Day 17 (Part 1, Cohorts 1, 2, and 3); baseline to Day 22 (Part 1, Cohorts 4 and 5); baseline to Day 21 (Part 2); baseline to Day 112 (Part 3)

• Change from baseline in phosphate

  Baseline to Day 17 (Part 1, Cohorts 1, 2, and 3); baseline to Day 22 (Part 1, Cohorts 4 and 5); baseline to Day 21 (Part 2); baseline to Day 112 (Part 3)

• Change from baseline in calcium

  Baseline to Day 17 (Part 1, Cohorts 1, 2, and 3); baseline to Day 22 (Part 1, Cohorts 4 and 5); baseline to Day 21 (Part 2); baseline to Day 112 (Part 3)

• Change from baseline in glucose

  Baseline to Day 17 (Part 1, Cohorts 1, 2, and 3); baseline to Day 22 (Part 1, Cohorts 4 and 5); baseline to Day 21 (Part 2); baseline to Day 112 (Part 3)

• Change from baseline in amylase

  Baseline to Day 17 (Part 1, Cohorts 1, 2, and 3); baseline to Day 22 (Part 1, Cohorts 4 and 5); baseline to Day 21 (Part 2); baseline to Day 112 (Part 3)

• Change from baseline in lipase

  Baseline to Day 17 (Part 1, Cohorts 1, 2, and 3); baseline to Day 22 (Part 1, Cohorts 4 and 5); baseline to Day 21 (Part 2); baseline to Day 112 (Part 3)

• Change from baseline in magnesium

  Baseline to Day 17 (Part 1, Cohorts 1, 2, and 3); baseline to Day 22 (Part 1, Cohorts 4 and 5); baseline to Day 21 (Part 2); baseline to Day 112 (Part 3)

• Change from baseline in albumin

  Baseline to Day 17 (Part 1, Cohorts 1, 2, and 3); baseline to Day 22 (Part 1, Cohorts 4 and 5); baseline to Day 21 (Part 2); baseline to Day 112 (Part 3)

• Change from baseline in lactate dehydrogenase (LDH)

  Baseline to Day 17 (Part 1, Cohorts 1, 2, and 3); baseline to Day 22 (Part 1, Cohorts 4 and 5); baseline to Day 21 (Part 2); baseline to Day 112 (Part 3)

• Change from baseline in creatine kinase

  Baseline to Day 17 (Part 1, Cohorts 1, 2, and 3); baseline to Day 22 (Part 1, Cohorts 4 and 5); baseline to Day 21 (Part 2); baseline to Day 112 (Part 3)

• Change from baseline in creatinine

  Baseline to Day 17 (Part 1, Cohorts 1, 2, and 3); baseline to Day 22 (Part 1, Cohorts 4 and 5); baseline to Day 21 (Part 2); baseline to Day 112 (Part 3)

• Change from baseline in blood urea nitrogen

  Baseline to Day 17 (Part 1, Cohorts 1, 2, and 3); baseline to Day 22 (Part 1, Cohorts 4 and 5); baseline to Day 21 (Part 2); baseline to Day 112 (Part 3)

• Change from baseline in alanine aminotransferase (ALT)

  Baseline to Day 17 (Part 1, Cohorts 1, 2, and 3); baseline to Day 22 (Part 1, Cohorts 4 and 5); baseline to Day 21 (Part 2); baseline to Day 112 (Part 3)

• Change from baseline in total alkaline phosphatase

  Baseline to Day 17 (Part 1, Cohorts 1, 2, and 3); baseline to Day 22 (Part 1, Cohorts 4 and 5); baseline to Day 21 (Part 2); baseline to Day 112 (Part 3)

• Change from baseline in aspartate aminotransferase (AST)

  Baseline to Day 17 (Part 1, Cohorts 1, 2, and 3); baseline to Day 22 (Part 1, Cohorts 4 and 5); baseline to Day 21 (Part 2); baseline to Day 112 (Part 3)

• Change from baseline in gamma-glutamyl transferase (GGT)

  Baseline to Day 17 (Part 1, Cohorts 1, 2, and 3); baseline to Day 22 (Part 1, Cohorts 4 and 5); baseline to Day 21 (Part 2); baseline to Day 112 (Part 3)

• Change from baseline in total bilirubin

  Baseline to Day 17 (Part 1, Cohorts 1, 2, and 3); baseline to Day 22 (Part 1, Cohorts 4 and 5); baseline to Day 21 (Part 2); baseline to Day 112 (Part 3)

• Change from baseline in direct bilirubin

  Baseline to Day 17 (Part 1, Cohorts 1, 2, and 3); baseline to Day 22 (Part 1, Cohorts 4 and 5); baseline to Day 21 (Part 2); baseline to Day 112 (Part 3)

• Change from baseline in indirect bilirubin

  Baseline to Day 17 (Part 1, Cohorts 1, 2, and 3); baseline to Day 22 (Part 1, Cohorts 4 and 5); baseline to Day 21 (Part 2); baseline to Day 112 (Part 3)

• Number of participants with abnormal urinalysis parameters

  Change from baseline in urinalysis (Including pH, specific gravity, glucose, protein, ketones, blood, nitrites, urobilinogen, and leukocyte esterase)

  Baseline to Day 17 (Part 1, Cohorts 1, 2, and 3); baseline to Day 22 (Part 1, Cohorts 4 and 5); baseline to Day 21 (Part 2); baseline to Day 112 (Part 3)

Secondary Outcomes (10)

• Maximum observed plasma concentration (Cmax) of ACCG-2671

  Predose through Day 22 (Part 1); predose through Day 18 (Part 2); predose through Day 112 (Part 3)

• Area under the plasma concentration-time curve from time zero to infinity (AUC0-inf) of ACCG-2671

  Predose through Day 22 (Part 1); predose through Day 18 (Part 2)

• Area under the plasma concentration-time curve from time zero to the last quantifiable concentration (AUC0-t) of ACCG-2671

  Predose through Day 22 (Part 1); predose through Day 18 (Part 2); predose through Day 112 (Part 3)

• Area under the plasma concentration-time curve over a dosing interval (AUC0-tau) of ACCG-2671

  Predose through Day 112 (Part 3)

• Time to reach maximum observed plasma concentration (Tmax) of ACCG-2671

  Predose through Day 22 (Part 1); predose through Day 18 (Part 2); predose through Day 112 (Part 3)

Study Arms (5)

Part 1 (SAD)

EXPERIMENTAL

Ascending doses of ACCG-2671 administered orally in healthy participants

Drug: ACCG-2671

Placebo Part 1 (SAD)

PLACEBO COMPARATOR

Administered orally in healthy participants

Drug: Placebo

Part 2 (Food-effect)

EXPERIMENTAL

Single low dose of ACCG-2671 administered orally in healthy participants under fasted and fed state

Drug: ACCG-2671

ACCG-2671 Part 3 (MAD)

EXPERIMENTAL

Escalating doses of ACCG-2671 administered orally for 84 days in participants living with obesity (BMI≥30 kg/m2)

Drug: ACCG-2671

Placebo Part 3 (MAD)

PLACEBO COMPARATOR

Placebo administered orally for 84 days in participants living with obesity (BMI≥30 kg/m2)

Drug: Placebo

Interventions

ACCG-2671 DRUG

Administered orally

ACCG-2671 Part 3 (MAD); Part 1 (SAD); Part 2 (Food-effect)

Placebo DRUG

Administered orally

Placebo Part 1 (SAD); Placebo Part 3 (MAD)

Eligibility Criteria

• Age: 25 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• For Parts 1 and Part 2: Participants with any clinically significant medical conditions are excluded from the study.
• 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.

Sponsors & Collaborators

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

Study Sites (6)

Research Site

Cypress, California, 90630, United States

NOT YET RECRUITING

Research Site

Lake Forest, California, 92630, United States

RECRUITING

Research Site

Decatur, Georgia, 30030, United States

NOT YET RECRUITING

Research Site

Dilworth, Minnesota, 56529, United States

RECRUITING

Research Site

Springfield, Missouri, 65802, United States

NOT YET RECRUITING

Research Site

Webster, Texas, 77598, United States

RECRUITING

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Sara Ahmed MD

CONTACT

650-647-0091; sara.ahmed@structuretx.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2026
• First Posted: September 11, 2026
• Study Start: December 29, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: September 14, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data sharing requests will be considered beginning 36 months after the study publication (manuscript accepted for publication) and either 1) the product has been granted marketing authorization in at least two regulatory jurisdictions, or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
• Access Criteria: Researchers will submit a request containing the research objectives, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). Aconcagua Bio, Inc. does not grant external requests for individual de-identified patient data for the following purposes: * Re-evaluating safety and efficacy end points already addressed in the product labelling, * Assessing safety or efficacy for an indication in current development Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a panel of external advisors. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement.

Locations

US (6)