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NCT Number: NCT07815678

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

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.

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Key information

Conditions

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

Age range

25 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Research Site, Cypress, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ACCG-2671

Drug

Administered orally

Placebo

Drug

Administered orally

Primary outcomes

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

    Time frame: 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)

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

    Time frame: 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)

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

    Time frame: Baseline to Day 21 (Part 2)

  4. Change from baseline in systolic blood pressure

    Time frame: 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)

  5. Change from baseline in diastolic blood pressure

    Time frame: 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)

  6. Change from baseline in heart rate

    Time frame: 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)

  7. Change from baseline in ECG ventricular heart rate

    Time frame: 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)

  8. Change from baseline in ECG PR interval

    Time frame: 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)

  9. Change from baseline ECG QRS duration

    Time frame: 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)

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

    Time frame: 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)

  11. Change from baseline in hemoglobin

    Time frame: 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)

  12. Change from baseline in hematocrit

    Time frame: 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)

  13. Change from baseline in thrombocyte count (platelet count)

    Time frame: 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)

  14. Change from baseline in white blood cell (WBC) count

    Time frame: 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)

  15. Change from baseline in prothrombin time

    Time frame: 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)

  16. Change from baseline in international normalized ratio (INR)

    Time frame: 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)

  17. Change from baseline in activated partial thromboplastin time (aPTT)

    Time frame: 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)

  18. Change from baseline in fibrinogen activity

    Time frame: 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)

  19. Change from baseline in sodium

    Time frame: 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)

  20. Change from baseline in potassium

    Time frame: 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)

  21. Change from baseline in chloride

    Time frame: 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)

  22. Change from baseline in phosphate

    Time frame: 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)

  23. Change from baseline in calcium

    Time frame: 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)

  24. Change from baseline in glucose

    Time frame: 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)

  25. Change from baseline in amylase

    Time frame: 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)

  26. Change from baseline in lipase

    Time frame: 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)

  27. Change from baseline in magnesium

    Time frame: 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)

  28. Change from baseline in albumin

    Time frame: 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)

  29. Change from baseline in lactate dehydrogenase (LDH)

    Time frame: 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)

  30. Change from baseline in creatine kinase

    Time frame: 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)

  31. Change from baseline in creatinine

    Time frame: 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)

  32. Change from baseline in blood urea nitrogen

    Time frame: 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)

  33. Change from baseline in alanine aminotransferase (ALT)

    Time frame: 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)

  34. Change from baseline in total alkaline phosphatase

    Time frame: 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)

  35. Change from baseline in aspartate aminotransferase (AST)

    Time frame: 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)

  36. Change from baseline in gamma-glutamyl transferase (GGT)

    Time frame: 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)

  37. Change from baseline in total bilirubin

    Time frame: 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)

  38. Change from baseline in direct bilirubin

    Time frame: 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)

  39. Change from baseline in indirect bilirubin

    Time frame: 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)

  40. Number of participants with abnormal urinalysis parameters

    Time frame: 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 urinalysis (Including pH, specific gravity, glucose, protein, ketones, blood, nitrites, urobilinogen, and leukocyte esterase)

Secondary outcomes

  1. Maximum observed plasma concentration (Cmax) of ACCG-2671

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

    Maximum observed plasma concentration of ACCG-2671

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

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

    Plasma AUC0-inf of ACCG-2671 following administration

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

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

    Plasma AUC0-t of ACCG-2671

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

    Time frame: Predose through Day 112 (Part 3)

    Plasma AUC0-tau of ACCG-2671, where tau is the dosing interval

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

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

    Time to reach the maximum observed plasma concentration of ACCG-2671

  6. Terminal elimination half-life (t½) of ACCG-2671

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

    Terminal elimination half-life of ACCG-2671 in plasma

  7. Trough plasma concentration (Ctrough) of ACCG-2671

    Time frame: Predose through Day 112 (Part 3)

    Predose plasma concentration of ACCG-2671 at the end of the dosing interval.

  8. Amount of ACCG-2671 excreted unchanged in urine (Ae)

    Time frame: Day -1 through Day 7 (Part 1, Cohorts 4 and 5)

    Cumulative amount of ACCG-2671 excreted unchanged in urine

  9. Fraction of ACCG-2671 excreted unchanged in urine (Fe)

    Time frame: Day -1 through Day 7 (Part 1, Cohorts 4 and 5)

    Fraction of the administered ACCG-2671 dose excreted unchanged in urine.

  10. Renal clearance (CLr) of ACCG-2671

    Time frame: Day -1 through Day 7 (Part 1, Cohorts 4 and 5)

    Renal clearance of ACCG-2671

Study contacts

Contact information is provided by the study sponsor or research team.

Sara Ahmed MD

CONTACT

[email protected]

650-647-0091

Sponsors and collaborators

Lead sponsor

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

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Sep 11, 2026
Registry last updated
Sep 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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