First-in-human Study of the Safety, Tolerability, Pharmacokinetics, and Food Effect of ACCG-2671
Recruiting
Phase 1Phase 2Interventional Study
Obesity
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
25 – 75
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
164 (estimated)
Sponsor
Aconcagua Bio, Inc. a wholly owned subsidiary of Structure Therapeutics · Industry
Who this trial is looking for
This trial is looking for healthy adults and adults with obesity to test the safety and effects of a new treatment called ACCG-2671. Participants will take the treatment in a few doses and provide information about how their bodies respond.
Are You a Good Fit for This Trial?
Must be takingGLP-1RA
You may be able to join if
I am between 25 and 65 years old for Parts 1 and 2, or between 25 and 75 years old for Part 3.
I have a body mass index (BMI) of 30 kg/m2 or more if I'm in Part 3.
I weigh at least 50 kg.
I can provide signed consent.
You may not be able to join if
I have had a significant medical condition.
I have a history of major heart, lung, liver, kidney, blood, digestive, hormonal, immune, skin, mental, or nerve diseases.
I had major surgery or an acute illness in the last 3 months.
I am taking any prescription or over-the-counter medications within 10 days before starting the study.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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.
Trial Locations
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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 a…
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.
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