ObesityPhase 2ACCESS IINCT06703021
A Dose-Range Study of Aleniglipron (GSBR-1290) in Participants Living With Obesity or Overweight With at Least One Weight-related Comorbidity
A Phase 2 study of Obesity and Overweight, run by Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics at 10 sites in United States.
Trial summary
Phase 2 clinical study will evaluate the safety, tolerability, pharmacokinetics (PK), and efficacy of various aleniglipron (GSBR-1290) dose regimens compared with placebo in participants living with obesity or overweight with ≥ 1 weight-related comorbidity, in addition to diet and exercise, over a 44-week period. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Obesity, Overweight, Chronic Weight Management
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 85 participants
- Where
- 10 sitesUnited States
- Study dates
- 20 Dec 2024to 12 Jan 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 18 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent
- BMI ≥30 kg/m2 or BMI ≥27.0 kg/m2 and previous/current diagnosis of ≥ 1 obesity related comorbidity
Who cannot join
- Previous documented diagnosis of diabetes mellitus
- Self-reported change in body weight >5% within 3 months before Screening
- Have a prior or planned surgical treatment for obesity (excluding liposuction or abdominoplasty, if performed >1 year prior to screening)
- Use of medications intended to promote weight loss, within 6 months prior to Screening
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
ACCESS II Research Site
Dallas, Texas, 75042
ACCESS II Research Site
East Greenwich, Rhode Island, 02818
ACCESS II Research Site
Glendale, California, 91206
ACCESS II Research Site
Medford, Oregon, 97504
ACCESS II Research Site
Montclair, California, 91763
ACCESS II Research Site
North Charleston, South Carolina, 29405
ACCESS II Research Site
San Antonio, Texas, 78240
ACCESS II Research Site
Valparaiso, Indiana, 46383
ACCESS II Research Site
West Des Moines, Iowa, 50265
ACCESS II Research Site
West Jordan, Utah, 84088
About this study
Official title: A Phase 2, Randomized, Double-blind, Placebo-controlled, Study of the Safety, Tolerability, and Efficacy of Increasing Optimal Doses of Aleniglipron (GSBR-1290) in Participants Living With Obesity (Body Mass Index ≥ 30 kg/m2) or Overweight (Body Mass Index ≥ 27 kg/m2) With at Least One Weight-related Comorbidity (ACCESS II)
Phase 2 clinical study will evaluate the safety, tolerability, pharmacokinetics (PK), and efficacy of various aleniglipron (GSBR-1290) dose regimens compared with placebo in participants living with obesity or overweight with ≥ 1 weight-related comorbidity, in addition to diet and exercise, over a 44-week period.
- Conditions
- Obesity, Overweight, Chronic Weight Management
- Being tested
- aleniglipron or placebo
- Keywords
- ACCESS II, Obesity, Overweight, GSBR-1290, Chronic weight management, Obese, Small molecule GLP-1 receptor agonist, Structure Therapeutics
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aleniglipron or placeboDrug
Drug: aleniglipron administered orally; Drug: placebo administered orally
aleniglipron or placeboDrug
Drug: aleniglipron administered orally; Drug: placebo administered orally
aleniglipron or placeboDrug
Drug: aleniglipron administered orally; Drug: placebo administered orally
aleniglipron or placeboDrug
Drug: aleniglipron administered orally; Drug: placebo administered orally
| Study group | Role | What they receive |
|---|---|---|
| Sentinel | Experimental | Participants will receive aleniglipron or placebo administered orally. Receives: Drug: aleniglipron or placebo |
| Cohort 1a | Experimental | Participants will receive aleniglipron or placebo administered orally. Receives: Drug: aleniglipron or placebo |
| Cohort 1b | Experimental | Participants will receive aleniglipron or placebo administered orally. Receives: Drug: aleniglipron or placebo |
| Cohort 1c | Experimental | Participants will receive aleniglipron or placebo administered orally. Receives: Drug: aleniglipron or placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)
Measured: Baseline and week 44
Adverse events of special interest
Measured: Baseline and week 44
Number of Participants With Clinically Significant Change From Baseline in Laboratory Parameters, including hematology, plasma chemistry, coagulation, and urinalysis
Measured: Baseline and week 44
Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Parameters: Common ECG-related variables will be assessed, including but not limited to : heart rate and QRS duration
Measured: Baseline and week 44
Number of Participants With Clinically Significant Change From Baseline in Vital Signs, including systolic and diastolic Blood Pressure, Heart Rate, Respiratory Rate, and temperature
Measured: Baseline and week 44
Secondary outcomes (5)
Area Under the Plasma Concentration-time Curve From Time 0 to Tau (AUC0-tau)
Measured: Baseline and week 44
Maximum Observed Plasma Concentration (Cmax) of aleniglipron
Measured: Baseline and week 44
Trough Concentrations (Ctrough) of aleniglipron
Measured: Baseline and week 44
Time of Maximum Observed Plasma Concentration (Tmax) of aleniglipron
Measured: Baseline and week 44
Terminal Elimination Half-life (t1/2) for aleniglipron
Measured: Baseline and week 44
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2024
- Study start20 Dec 2024
- Primary completion12 Jan 2026
- Study completion12 Jan 2026
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gasherbrum 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
- NCT06703021
- Sponsor's protocol ID
- GSBR-1290-09
- Acronym
- ACCESS II
- Status last verified
- Sep 2025
- First submitted
- 15 Nov 2024
- Last updated
- 28 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Double-blind, Placebo-controlled, Study of the Safety, Tolerability, and Efficacy of Increasing Optimal Doses of Aleniglipron (GSBR-1290) in Participants Living With Obesity (Body Mass Index ≥ 30 kg/m2) or Overweight (Body Mass Index ≥ 27 kg/m2) With at Least One Weight-related Comorbidity (ACCESS II)
- ClinicalTrials.gov ID
- NCT06703021
- Acronym / sponsor ID
- ACCESS II / GSBR-1290-09
- Conditions
- Obesity, Overweight, Chronic Weight Management
- Keywords
- ACCESS II, Obesity, Overweight, GSBR-1290, Chronic weight management, Obese, Small molecule GLP-1 receptor agonist, Structure Therapeutics
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 20 Dec 2024 (actual)
- Primary completion
- 12 Jan 2026 (actual)
- Study completion
- 12 Jan 2026 (actual)
- First posted
- 25 Nov 2024 (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.
Phase 2 clinical study will evaluate the safety, tolerability, pharmacokinetics (PK), and efficacy of various aleniglipron (GSBR-1290) dose regimens compared with placebo in participants living with obesity or overweight with ≥ 1 weight-related comorbidity, in addition to diet and exercise, over a 44-week period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Sentinel | Experimental | Drug: aleniglipron or placeboParticipants will receive aleniglipron or placebo administered orally. |
| Cohort 1a | Experimental | Drug: aleniglipron or placeboParticipants will receive aleniglipron or placebo administered orally. |
| Cohort 1b | Experimental | Drug: aleniglipron or placeboParticipants will receive aleniglipron or placebo administered orally. |
| Cohort 1c | Experimental | Drug: aleniglipron or placeboParticipants will receive aleniglipron or placebo administered orally. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Signed informed consent
- BMI ≥30 kg/m2 or BMI ≥27.0 kg/m2 and previous/current diagnosis of ≥ 1 obesity related comorbidity
Key exclusion criteria (4 listed)
- Previous documented diagnosis of diabetes mellitus
- Self-reported change in body weight >5% within 3 months before Screening
- Have a prior or planned surgical treatment for obesity (excluding liposuction or abdominoplasty, if performed >1 year prior to screening)
- Use of medications intended to promote weight loss, within 6 months prior to Screening
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 |
|---|---|---|
| aleniglipron or placeboDrug: aleniglipron administered orally; Drug: placebo administered orally | Drug | Cohort 1a |
| aleniglipron or placeboDrug: aleniglipron administered orally; Drug: placebo administered orally | Drug | Cohort 1b |
| aleniglipron or placeboDrug: aleniglipron administered orally; Drug: placebo administered orally | Drug | Cohort 1c |
| aleniglipron or placeboDrug: aleniglipron administered orally; Drug: placebo administered orally | Drug | Sentinel |
Primary outcome
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)
Time frame: Baseline and week 44
Adverse events of special interest
Time frame: Baseline and week 44
Number of Participants With Clinically Significant Change From Baseline in Laboratory Parameters, including hematology, plasma chemistry, coagulation, and urinalysis
Time frame: Baseline and week 44
Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Parameters: Common ECG-related variables will be assessed, including but not limited to : heart rate and QRS duration
Time frame: Baseline and week 44
Number of Participants With Clinically Significant Change From Baseline in Vital Signs, including systolic and diastolic Blood Pressure, Heart Rate, Respiratory Rate, and temperature
Time frame: Baseline and week 44
5 secondary outcomes
Area Under the Plasma Concentration-time Curve From Time 0 to Tau (AUC0-tau)
Time frame: Baseline and week 44
Maximum Observed Plasma Concentration (Cmax) of aleniglipron
Time frame: Baseline and week 44
Trough Concentrations (Ctrough) of aleniglipron
Time frame: Baseline and week 44
Time of Maximum Observed Plasma Concentration (Tmax) of aleniglipron
Time frame: Baseline and week 44
Terminal Elimination Half-life (t1/2) for aleniglipron
Time frame: Baseline and week 44
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study of Obesity and Overweight, run by Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics at 10 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 2 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: finished, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) (time frame: Baseline and week 44). The study lists 5 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 28 Apr 2026.