First-in-human Study of the Safety, Tolerability, Pharmacokinetics, and Food Effect of ACCG-2671
Purpose
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.
Condition
- Obesity
Eligibility
- Eligible Ages
- Between 25 Years and 75 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- Yes
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
- Phase
- Phase 1/Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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) |
|
Recruiting Locations
Lake Forest, California 92630
Dilworth, Minnesota 56529
Webster, Texas 77598
More Details
- Status
- Recruiting
- Sponsor
- Aconcagua Bio, Inc. a wholly owned subsidiary of Structure Therapeutics
Detailed Description
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.