Obesity, Overweight, or Chronic Weight ManagementPhase 2ACCESSNCT06693843
A Phase 2b, Dose-range Finding Study of the Efficacy and Safety of Multiple Doses of Aleniglipron (GSBR-1290) in Participants Living With Obesity or Overweight With at Least One Weight-related Comorbidity
A Phase 2 study testing Aleniglipron in people with Obesity, Overweight, or Chronic Weight Management, run by Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics at 39 sites in United States.
Trial summary
This study is a randomized, double-blind, placebo-controlled, dose-range finding study of the efficacy, safety, tolerability, PK, and PD of multiple doses of aleniglipron in participants living with overweight or obesity with at least one weight-related comorbidity. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Obesity, Overweight, or Chronic Weight Management
- What is being tested?
- Aleniglipron
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 230 participants
- Where
- 39 sitesUnited States
- Study dates
- 28 Oct 2024to 9 Jul 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
- Body weight ≤80 kg at Screening
- Have a prior or planned surgical treatment for obesity (excluding liposuction or abdominoplasty, if performed >1 year prior to screening)
Trial locations and contacts
39 sites in 1 country.
39 sites in 1 country
United States39 sites
ACCESS Research Site
Albany, New York, 12203
ACCESS Research Site
Anaheim, California, 92801
ACCESS Research Site
Austin, Texas, 78704
ACCESS Research Site
Austin, Texas, 78731
ACCESS Research Site
Baton Rouge, Louisiana, 70808
ACCESS Research Site
Binghamton, New York, 13905
ACCESS Research Site
Brooklyn, New York, 10016
ACCESS Research Site
Chattanooga, Tennessee, 37421
ACCESS Research Site
Chicago, Illinois, 60602
ACCESS Research Site
Chicago, Illinois, 60637
ACCESS Research Site
Cincinnati, Ohio, 45219
ACCESS Research Site
City of Saint Peters, Missouri, 63303
ACCESS Research Site
Dallas, Texas, 75226
ACCESS Research Site
Dallas, Texas, 75243
ACCESS Research Site
Evanston, Illinois, 60201
ACCESS Research Site
Hazelwood, Missouri, 63042
ACCESS Research Site
Honolulu, Hawaii, 96814
ACCESS Research Site
Los Angeles, California, 90057
ACCESS Research Site
Medford, Oregon, 97504
ACCESS Research Site
Mesquite, Texas, 75149
ACCESS Research Site
Moncks Corner, South Carolina, 29461
ACCESS Research Site
Montclair, California, 91763
ACCESS Research Site
Morgantown, West Virginia, 26505
ACCESS Research Site
Muncie, Indiana, 47304
ACCESS Research Site
Norman, Oklahoma, 73069
ACCESS Research Site
Phoenix, Arizona, 85044
ACCESS Research Site
Pittsburgh, Pennsylvania, 15236
ACCESS Research Site
Rancho Cucamonga, California, 91730
ACCESS Research Site
Richfield, Minnesota, 55423
ACCESS Research Site
Rochester, New York, 14609
ACCESS Research Site
Sacramento, California, 95821
ACCESS Research Site
Shavano Park, Texas, 78231
ACCESS Research Site
Spring Valley, California, 91978
ACCESS Research Site
Springfield, Missouri, 65807
ACCESS Research Site
Valparaiso, Indiana, 46383
ACCESS Research Site
West Des Moines, Iowa, 50265
ACCESS Research Site
West Jordan, Utah, 84088
ACCESS Research Site
Wilmington, North Carolina, 28403
ACCESS Research Site
Winchester, Virginia, 22601
About this study
Official title: A Phase 2b, Randomized, Double-blind, Placebo-controlled, Dose-range Finding Study of the Efficacy and Safety of Multiple 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
This study is a randomized, double-blind, placebo-controlled, dose-range finding study of the efficacy, safety, tolerability, PK, and PD of multiple doses of aleniglipron in participants living with overweight or obesity with at least one weight-related comorbidity. Participants will be randomized to aleniglipron or placebo in a ratio of 3:1 within each Cohort receiving multiple-ascending, QD doses of aleniglipron or placebo in titration steps of 4 weeks duration for a total of 36 weeks of treatment. At the end of the study (after completing 36 weeks of treatment), participants will be offered to continue with an open-label extension (OLE) where they will receive aleniglipron for an additional 36 weeks.
- Being tested
- Aleniglipron or Placebo, Aleniglipron
- Keywords
- ACCESS, obesity, overweight, GSBR-1290, aleniglipron, 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
AleniglipronDrug
Drug: Aleniglipron Administered orally
AleniglipronDrug
Drug: Aleniglipron Administered orally
AleniglipronDrug
Drug: Aleniglipron Administered orally
AleniglipronDrug
Drug: Aleniglipron Administered orally
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Participants will receive Aleniglipron or Placebo administered orally. Receives: Drug: Aleniglipron or Placebo |
| Cohort 2 | Experimental | Participants will receive Aleniglipron or Placebo administered orally. Receives: Drug: Aleniglipron or Placebo |
| Cohort 3 | Experimental | Participants will receive Aleniglipron or Placebo administered orally. Receives: Drug: Aleniglipron or Placebo |
| Cohort 1 OLE | Active comparator | Participants will receive Aleniglipron administered orally Receives: Drug: Aleniglipron |
| Cohort 2 OLE | Active comparator | Participants will receive Aleniglipron administered orally Receives: Drug: Aleniglipron |
| Cohort 3 OLE | Active comparator | Participants will receive Aleniglipron administered orally Receives: Drug: Aleniglipron |
| Cohort 4 OLE | Active comparator | Participants will receive Aleniglipron administered orally Receives: Drug: Aleniglipron |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change in body weight from Baseline to Week 36
Double Blind Period
Measured: Baseline and week 36
TEAEs and SAEs
Open -Label Extension
Measured: Baseline and week 72
AESI
Open -Label Extension
Measured: Baseline and week 72
Evaluate the safety and tolerability of participants with abnormal laboratory values, including hematology, serum chemistry, and coagulation
Open -Label Extension
Measured: Baseline and week 72
Evaluate long-term safety and tolerability of aleniglipron as measured through electrocardiograms (including, but not limited to, the measurements of ventricular HR, PR interval, QRS duration, QT interval, and QTcF)
Open -Label Extension
Measured: Baseline and week 72
Evaluate the safety and tolerability of participants with abnormal vital signs, including blood pressure, heart rate, and temperature
Open -Label Extension
Measured: Baseline and week 72
Secondary outcomes (13)
Percentage of participants who achieve ≥5% reduction in body weight at Week 36
Double Blind Period
Measured: Baseline and week 36
Percentage of participants who achieve ≥10% reduction in body weight at Week 36
Double Blind Period
Measured: Baseline and week 36
Percentage of participants who achieve ≥15% reduction in body weight at Week 36
Double Blind Period
Measured: Baseline and week 36
Change in body weight (absolute) from Baseline to Week 36
Double Blind Period
Measured: Baseline and week 36
Change in waist circumference from Baseline to Week 36
Double Blind Period
Measured: Baseline and week 36
Change in body mass index from Baseline to Week 36
Double Blind Period
Measured: Baseline and week 36
Percent change in body weight
Open -Label Extension
Measured: Baseline to week 72 & Week 36-72
Percentage of participants who achieve ≥5% reduction in body weight
Open -Label Extension
Measured: Baseline to week 72 & Week 36-72
Percentage of participants who achieve ≥10% reduction in body weight
Open -Label Extension
Measured: Baseline to week 72 & Week 36-72
Percentage of participants who achieve ≥15% reduction in body weight
Open -Label Extension
Measured: Baseline to week 72 & Week 36-72
Change in body weight
Open -Label Extension
Measured: Baseline to week 72 & Week 36-72
Change in body mass
Open -Label Extension
Measured: Baseline to week 72 & Week 36-72
Change in waist circumference
Open -Label Extension
Measured: Baseline to week 72 & Week 36-72
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2024
- Study start28 Oct 2024
- Primary completion24 Oct 2025
- Study completion9 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obesity, Overweight, or Chronic Weight ManagementStudies 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
- 230 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
- NCT06693843
- Sponsor's protocol ID
- GSBR-1290-06
- Acronym
- ACCESS
- Status last verified
- Aug 2026
- First submitted
- 15 Nov 2024
- Last updated
- 10 Aug 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
Publications
Rosenstock J, Lingvay I, Ryan D, Jastreboff AM, Kushner R, Acosta A, Blevins TC, Choi M, Holmes FL, Smith T, Connery L, Li Y, Liu MK, Barth A, Butcher J, Civitarese A, Yue H, Coll B; ACCESS Trial Investigators. Oral small molecule GLP-1 receptor agonist aleniglipron in people with overweight or obesity: a randomized, double-blind, placebo-controlled phase 2b trial. Nat Med. 2026 Jun 5. doi: 10.1038/s41591-026-04476-6. Online ahead of print.
PubMed 42249138
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2b, Randomized, Double-blind, Placebo-controlled, Dose-range Finding Study of the Efficacy and Safety of Multiple 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
- ClinicalTrials.gov ID
- NCT06693843
- Acronym / sponsor ID
- ACCESS / GSBR-1290-06
- Keywords
- ACCESS, obesity, overweight, GSBR-1290, aleniglipron, chronic weight management, obese, small molecule, GLP-1 receptor agonist, Structure Therapeutics
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 230 participants (actual)
- Lead sponsor
- Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 28 Oct 2024 (actual)
- Primary completion
- 24 Oct 2025 (actual)
- Study completion
- 9 Jul 2026 (actual)
- First posted
- 18 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.
This study is a randomized, double-blind, placebo-controlled, dose-range finding study of the efficacy, safety, tolerability, PK, and PD of multiple doses of aleniglipron in participants living with overweight or obesity with at least one weight-related comorbidity. Participants will be randomized to aleniglipron or placebo in a ratio of 3:1 within each Cohort receiving multiple-ascending, QD doses of aleniglipron or placebo in titration steps of 4 weeks duration for a total of 36 weeks of treatment. At the end of the study (after completing 36 weeks of treatment), participants will be offered to continue with an open-label extension (OLE) where they will receive aleniglipron for an additional 36 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: Aleniglipron or PlaceboParticipants will receive Aleniglipron or Placebo administered orally. |
| Cohort 2 | Experimental | Drug: Aleniglipron or PlaceboParticipants will receive Aleniglipron or Placebo administered orally. |
| Cohort 3 | Experimental | Drug: Aleniglipron or PlaceboParticipants will receive Aleniglipron or Placebo administered orally. |
| Cohort 1 OLE | Active comparator | Drug: AleniglipronParticipants will receive Aleniglipron administered orally |
| Cohort 2 OLE | Active comparator | Drug: AleniglipronParticipants will receive Aleniglipron administered orally |
| Cohort 3 OLE | Active comparator | Drug: AleniglipronParticipants will receive Aleniglipron administered orally |
| Cohort 4 OLE | Active comparator | Drug: AleniglipronParticipants will receive Aleniglipron 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
- Body weight ≤80 kg at Screening
- Have a prior or planned surgical treatment for obesity (excluding liposuction or abdominoplasty, if performed >1 year 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 1 |
| Aleniglipron or PlaceboDrug: Aleniglipron Administered orally Drug: Placebo Administered orally | Drug | Cohort 2 |
| Aleniglipron or PlaceboDrug: Aleniglipron Administered orally Drug: Placebo Administered orally | Drug | Cohort 3 |
| AleniglipronDrug: Aleniglipron Administered orally | Drug | Cohort 1 OLE |
| AleniglipronDrug: Aleniglipron Administered orally | Drug | Cohort 2 OLE |
| AleniglipronDrug: Aleniglipron Administered orally | Drug | Cohort 3 OLE |
| AleniglipronDrug: Aleniglipron Administered orally | Drug | Cohort 4 OLE |
Primary outcome
Percent change in body weight from Baseline to Week 36
Time frame: Baseline and week 36
Double Blind Period
TEAEs and SAEs
Time frame: Baseline and week 72
Open -Label Extension
AESI
Time frame: Baseline and week 72
Open -Label Extension
Evaluate the safety and tolerability of participants with abnormal laboratory values, including hematology, serum chemistry, and coagulation
Time frame: Baseline and week 72
Open -Label Extension
Evaluate long-term safety and tolerability of aleniglipron as measured through electrocardiograms (including, but not limited to, the measurements of ventricular HR, PR interval, QRS duration, QT interval, and QTcF)
Time frame: Baseline and week 72
Open -Label Extension
Evaluate the safety and tolerability of participants with abnormal vital signs, including blood pressure, heart rate, and temperature
Time frame: Baseline and week 72
Open -Label Extension
13 secondary outcomes
Percentage of participants who achieve ≥5% reduction in body weight at Week 36
Time frame: Baseline and week 36
Percentage of participants who achieve ≥10% reduction in body weight at Week 36
Time frame: Baseline and week 36
Percentage of participants who achieve ≥15% reduction in body weight at Week 36
Time frame: Baseline and week 36
Change in body weight (absolute) from Baseline to Week 36
Time frame: Baseline and week 36
Change in waist circumference from Baseline to Week 36
Time frame: Baseline and week 36
Change in body mass index from Baseline to Week 36
Time frame: Baseline and week 36
Percent change in body weight
Time frame: Baseline to week 72 & Week 36-72
Percentage of participants who achieve ≥5% reduction in body weight
Time frame: Baseline to week 72 & Week 36-72
Percentage of participants who achieve ≥10% reduction in body weight
Time frame: Baseline to week 72 & Week 36-72
Percentage of participants who achieve ≥15% reduction in body weight
Time frame: Baseline to week 72 & Week 36-72
Change in body weight
Time frame: Baseline to week 72 & Week 36-72
Change in body mass
Time frame: Baseline to week 72 & Week 36-72
Change in waist circumference
Time frame: Baseline to week 72 & Week 36-72
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 10 Aug 2026.
- Derived from this study: PubMed 42249138Rosenstock J, Lingvay I, Ryan D, Jastreboff AM, Kushner R, Acosta A, Blevins TC, Choi M, Holmes FL, Smith T, Connery L, Li Y, Liu MK, Barth A, Butcher J, Civitarese A, Yue H, Coll B; ACCESS Trial Investigators. Oral small molecule GLP-1 receptor agonist aleniglipron in people with overweight or obesity: a randomized, double-blind, placebo-controlled phase 2b trial. Nat Med. 2026 Jun 5. doi: 10.1038/s41591-026-04476-6. Online ahead of print.
- 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.
39 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Aleniglipron in people with Obesity, Overweight, or Chronic Weight Management, run by Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics at 39 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 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 39 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?
Percent change in body weight from Baseline to Week 36 (time frame: Baseline and week 36). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06693843, which also lists 1 linked publication.
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 10 Aug 2026.