Recruiting
Phase 1
Phase 2

ACCG-2671

Sponsor:

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

Code:

NCT07815678

Conditions

Obesity

Eligibility Criteria

Sex: All

Age: 25 - 70+

Healthy Volunteers: Accepted

Interventions

ACCG-2671

Placebo

Study Details

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

Study ID

NCT07815678

Start date

Dec 29, 2025

Status verified date

Sep, 2026

Completion date

Apr, 2027

Anticipated

Primary completion date

Mar, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 25 - 70+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

164 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Part 1 (SAD)

Ascending doses of ACCG-2671 administered orally in healthy participants

placebo comparator: Placebo Part 1 (SAD)

Administered orally in healthy participants

experimental: Part 2 (Food-effect)

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

experimental: ACCG-2671 Part 3 (MAD)

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

placebo comparator: Placebo Part 3 (MAD)

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

Interventions

ACCG-2671

Administered orally

Placebo

Administered orally

Primary outcome measure

  • 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) ]
  • 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) ]
  • 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) ]
  • 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) ]
  • 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) ]
  • 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) ]
  • 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) ]
  • 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) ]
  • 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) ]
  • 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) ]
  • 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) ]
  • 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) ]
  • 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) ]
  • 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) ]
  • 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) ]
  • 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) ]
  • 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) ]
  • 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) ]
  • 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) ]
  • 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) ]
  • 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) ]
  • 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) ]
  • 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) ]
  • 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) ]
  • 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) ]
  • 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) ]
  • 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) ]
  • 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) ]
  • 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) ]
  • 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) ]
  • 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) ]
  • 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) ]
  • 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) ]
  • 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) ]
  • 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) ]
  • 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) ]
  • 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) ]
  • 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) ]
  • 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) ]
  • 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) ]

Central Contacts and Locations

Central contacts

Sara Ahmed MD

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

Locations

Research Site

Recruiting

Lake Forest, California, United States, 92630

Contacts

Medical Director

650-457-1959ACCGClinicalTrials@Structuretx.com

More Information

Sponsor

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

Last update posted

Sep 11, 2026

Last verified

Sep, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-12. This information was provided to ClinicalTrials.gov by Aconcagua Bio, Inc. a wholly owned subsidiary of Structure Therapeutics on 2026-09-11.