ObesityPhase 1/2NCT07815678
First-in-human Study of the Safety, Tolerability, Pharmacokinetics, and Food Effect of ACCG-2671
A Phase 1/2 study testing ACCG-2671 in people with Obesity, run by Aconcagua Bio, Inc. a wholly owned subsidiary of Structure Therapeutics at 6 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- ACCG-2671
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 164 participants
- Where
- 6 sitesUnited States
- Study dates
- 29 Dec 2025to Apr 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
United States6 sites, 6 recruiting
- Not yet recruiting
Research Site
Cypress, California, 90630
Medical Director, 650-457-1959, ACCGClinicalTrials@Structuretx.com
- Not yet recruiting
Research Site
Decatur, Georgia, 30030
Principal Investigator, 650-457-1959, ACCGClinicalTrials@Structuretx.com
- Recruiting
Research Site
Dilworth, Minnesota, 56529
Principal Investigator, 650-457-1959, ACCGClinicalTrials@Structuretx.com
- Recruiting
Research Site
Lake Forest, California, 92630
Medical Director, 650-457-1959, ACCGClinicalTrials@Structuretx.com
- Not yet recruiting
Research Site
Springfield, Missouri, 65802
Medical Director, 650-457-1959, ACCGClinicalTrials@Structuretx.com
- Recruiting
Research Site
Webster, Texas, 77598
Medical Director, 650-457-1959, ACCGClinicalTrials@Structuretx.com
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, First-in-human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Food-effect of ACCG-2671
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.
Read the 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.
- Conditions
- Obesity
- Being tested
- ACCG-2671, Placebo
- Keywords
- Obesity, Amylin, Structure Therapeutics, Intervention/Treatment, Drug: Placebo, DRUG:ACCG-2671
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACCG-2671Drug
Administered orally
PlaceboDrug
Administered orally
| Study group | Role | What they receive |
|---|---|---|
| Part 1 (SAD) | Experimental | Ascending doses of ACCG-2671 administered orally in healthy participants Receives: Drug: ACCG-2671 |
| Placebo Part 1 (SAD) | Placebo comparator | Administered orally in healthy participants Receives: Drug: Placebo |
| Part 2 (Food-effect) | Experimental | Single low dose of ACCG-2671 administered orally in healthy participants under fasted and fed state Receives: Drug: ACCG-2671 |
| ACCG-2671 Part 3 (MAD) | Experimental | Escalating doses of ACCG-2671 administered orally for 84 days in participants living with obesity (BMI≥30 kg/m2) Receives: Drug: ACCG-2671 |
| Placebo Part 3 (MAD) | Placebo comparator | Placebo administered orally for 84 days in participants living with obesity (BMI≥30 kg/m2) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with one or more adverse events (AEs) as assessed by CTCAE v5.0
Measured: 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
Measured: 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
Measured: Baseline to Day 21 (Part 2)
Change from baseline in systolic blood pressure
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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
Measured: 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
Measured: 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)
Measured: 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
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Change from baseline in urinalysis (Including pH, specific gravity, glucose, protein, ketones, blood, nitrites, urobilinogen, and leukocyte esterase)
Measured: 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)
Secondary outcomes (10)
Maximum observed plasma concentration (Cmax) of ACCG-2671
Maximum observed plasma concentration of ACCG-2671
Measured: Predose through Day 22 (Part 1); predose through Day 18 (Part 2); predose through Day 112 (Part 3)
Area under the plasma concentration-time curve from time zero to infinity (AUC0-inf) of ACCG-2671
Plasma AUC0-inf of ACCG-2671 following administration
Measured: Predose through Day 22 (Part 1); predose through Day 18 (Part 2)
Area under the plasma concentration-time curve from time zero to the last quantifiable concentration (AUC0-t) of ACCG-2671
Plasma AUC0-t of ACCG-2671
Measured: Predose through Day 22 (Part 1); predose through Day 18 (Part 2); predose through Day 112 (Part 3)
Area under the plasma concentration-time curve over a dosing interval (AUC0-tau) of ACCG-2671
Plasma AUC0-tau of ACCG-2671, where tau is the dosing interval
Measured: Predose through Day 112 (Part 3)
Time to reach maximum observed plasma concentration (Tmax) of ACCG-2671
Time to reach the maximum observed plasma concentration of ACCG-2671
Measured: Predose through Day 22 (Part 1); predose through Day 18 (Part 2); predose through Day 112 (Part 3)
Terminal elimination half-life (t½) of ACCG-2671
Terminal elimination half-life of ACCG-2671 in plasma
Measured: Predose through Day 22 (Part 1); predose through Day 18 (Part 2); predose through Day 112 (Part 3)
Trough plasma concentration (Ctrough) of ACCG-2671
Predose plasma concentration of ACCG-2671 at the end of the dosing interval.
Measured: Predose through Day 112 (Part 3)
Amount of ACCG-2671 excreted unchanged in urine (Ae)
Cumulative amount of ACCG-2671 excreted unchanged in urine
Measured: Day -1 through Day 7 (Part 1, Cohorts 4 and 5)
Fraction of ACCG-2671 excreted unchanged in urine (Fe)
Fraction of the administered ACCG-2671 dose excreted unchanged in urine.
Measured: Day -1 through Day 7 (Part 1, Cohorts 4 and 5)
Renal clearance (CLr) of ACCG-2671
Renal clearance of ACCG-2671
Measured: Day -1 through Day 7 (Part 1, Cohorts 4 and 5)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2026
- Study start29 Dec 2025
- Primary completionMar 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 164 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aconcagua Bio, Inc. a wholly owned subsidiary of Structure Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07815678
- Sponsor's protocol ID
- ACCG-2671-01
- Status last verified
- Sep 2026
- First submitted
- 13 Aug 2026
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual patient data for variables necessary to address a specific research question in an approved data sharing request
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, First-in-human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Food-effect of ACCG-2671
- ClinicalTrials.gov ID
- NCT07815678
- Acronym / sponsor ID
- ACCG-2671-01
- Conditions
- Obesity
- Keywords
- Obesity, Amylin, Structure Therapeutics, Intervention/Treatment, Drug: Placebo, DRUG:ACCG-2671
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 164 participants (estimated)
- Lead sponsor
- Aconcagua Bio, Inc. a wholly owned subsidiary of Structure TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 29 Dec 2025 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 11 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Part 1 (SAD) | Experimental | Drug: ACCG-2671Ascending doses of ACCG-2671 administered orally in healthy participants |
| Placebo Part 1 (SAD) | Placebo comparator | Drug: PlaceboAdministered orally in healthy participants |
| Part 2 (Food-effect) | Experimental | Drug: ACCG-2671Single low dose of ACCG-2671 administered orally in healthy participants under fasted and fed state |
| ACCG-2671 Part 3 (MAD) | Experimental | Drug: ACCG-2671Escalating doses of ACCG-2671 administered orally for 84 days in participants living with obesity (BMI≥30 kg/m2) |
| Placebo Part 3 (MAD) | Placebo comparator | Drug: PlaceboPlacebo administered orally for 84 days in participants living with obesity (BMI≥30 kg/m2) |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACCG-2671Administered orally | Drug | ACCG-2671 Part 3 (MAD), Part 1 (SAD), Part 2 (Food-effect) |
| PlaceboAdministered orally | Drug | Placebo Part 1 (SAD), Placebo Part 3 (MAD) |
Primary outcome
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)
Change from baseline in urinalysis (Including pH, specific gravity, glucose, protein, ketones, blood, nitrites, urobilinogen, and leukocyte esterase)
10 secondary outcomes
Maximum observed plasma concentration (Cmax) of ACCG-2671
Time frame: Predose through Day 22 (Part 1); predose through Day 18 (Part 2); predose through Day 112 (Part 3)
Area under the plasma concentration-time curve from time zero to infinity (AUC0-inf) of ACCG-2671
Time frame: Predose through Day 22 (Part 1); predose through Day 18 (Part 2)
Area under the plasma concentration-time curve from time zero to the last quantifiable concentration (AUC0-t) of ACCG-2671
Time frame: Predose through Day 22 (Part 1); predose through Day 18 (Part 2); predose through Day 112 (Part 3)
Area under the plasma concentration-time curve over a dosing interval (AUC0-tau) of ACCG-2671
Time frame: Predose through Day 112 (Part 3)
Time to reach maximum observed plasma concentration (Tmax) of ACCG-2671
Time frame: Predose through Day 22 (Part 1); predose through Day 18 (Part 2); predose through Day 112 (Part 3)
Terminal elimination half-life (t½) of ACCG-2671
Time frame: Predose through Day 22 (Part 1); predose through Day 18 (Part 2); predose through Day 112 (Part 3)
Trough plasma concentration (Ctrough) of ACCG-2671
Time frame: Predose through Day 112 (Part 3)
Amount of ACCG-2671 excreted unchanged in urine (Ae)
Time frame: Day -1 through Day 7 (Part 1, Cohorts 4 and 5)
Fraction of ACCG-2671 excreted unchanged in urine (Fe)
Time frame: Day -1 through Day 7 (Part 1, Cohorts 4 and 5)
Renal clearance (CLr) of ACCG-2671
Time frame: Day -1 through Day 7 (Part 1, Cohorts 4 and 5)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Individual participant dataSharing planned: Yes. De-identified individual patient data for variables necessary to address a specific research question in an approved data sharing request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ACCG-2671 in people with Obesity, run by Aconcagua Bio, Inc. a wholly owned subsidiary of Structure Therapeutics at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sara Ahmed MD (650-647-0091, sara.ahmed@structuretx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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)). The study lists 40 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.