NCT07815678 First-in-human Study of the Safety, Tolerability, Pharmacokinetics, and Food Effect of ACCG-2671
| NCT ID | NCT07815678 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Aconcagua Bio, Inc. a wholly owned subsidiary of Structure Therapeutics |
| Condition | Obesity |
| Study Type | INTERVENTIONAL |
| Enrollment | 164 participants |
| Start Date | 2025-12-29 |
| Primary Completion | 2027-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 164 participants in total. It began in 2025-12-29 with a primary completion date of 2027-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07815678 clinical trial?
This trial is open to participants of all sexes, aged 25 Years or older, up to 75 Years, studying Obesity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07815678 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07815678 currently recruiting?
Yes, NCT07815678 is actively recruiting participants. Contact the research team at sara.ahmed@structuretx.com for enrollment information.
Where is the NCT07815678 trial being conducted?
This trial is being conducted at Cypress, United States, Lake Forest, United States, Decatur, United States, Dilworth, United States and 2 additional locations.
Who is sponsoring the NCT07815678 clinical trial?
NCT07815678 is sponsored by Aconcagua Bio, Inc. a wholly owned subsidiary of Structure Therapeutics. The trial plans to enroll 164 participants.
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