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

Part of paid clinical trials in Cypress, California.

Sponsor
Aconcagua Bio, Inc. a wholly owned subsidiary of Structure Therapeutics
Study ID
NCT07815678
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
25 Years - 75 Years
Healthy Volunteers
Accepted

Interventions

  • ACCG-2671 — DRUG
    Administered orally
  • Placebo — DRUG
    Administered orally

Study Details

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.

Key Dates

First listed
Sep 11, 2026
Start date
Dec 29, 2025
Status verified
Sep 2026
Primary completion
Mar 31, 2027
Completion
Apr 30, 2027

Study Design

Enrollment
164 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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)

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) ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
Research SiteCypressCalifornia90630
Medical Director
[email protected]
650-457-1959
Research SiteLake ForestCalifornia92630
Medical Director
[email protected]
650-457-1959
Research SiteDecaturGeorgia30030
Principal Investigator
[email protected]
650-457-1959
Research SiteDilworthMinnesota56529
Principal Investigator
[email protected]
650-457-1959
Research SiteSpringfieldMissouri65802
Medical Director
[email protected]
650-457-1959
Research SiteWebsterTexas77598
Medical Director
[email protected]
650-457-1959

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