Overweight or ObesityPhase 1/2NCT05762471
Phase 1b/2a Study of GSBR-1290 in Adult Overweight or Obese Healthy Subjects and Subjects With Type 2 Diabetes Mellitus
A Phase 1/2 study testing GSBR-1290 in people with Overweight or Obesity and Type2 Diabetes Mellitus, run by Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics at 4 sites in United States.
Trial summary
This study will evaluate safety, tolerability, pharmacokinetic (PK) profile, and pharmacodynamic (PD) effects on GSBR-1290 in healthy overweight/obese volunteers (HOV) and Type 2 Diabetes Mellitus on Metformin (T2DM) This study includes 5 planned cohorts. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Overweight or Obesity, Type2 Diabetes Mellitus
- What is being tested?
- GSBR-1290
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 142 participants
- Where
- 4 sitesUnited States
- Study dates
- 9 Jan 2023to 11 Apr 2024
- Phase
- Phase 1/2
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provided evidence of a signed consent
- Age ≥ 18 and ≤ 75 years
- Healthy overweight/obese adult men and women with body mass index ≥ 27 and ≤ 40 kg/m2
- No nicotine use
- Have a suitable venous access for blood sampling
- Men and women with T2DM of ≥6 months duration
Show all 9Show fewer
- Age ≥ 18 and ≤ 75 years
- BMI ≥ 27 and ≤ 40 kg/m2
- Treated with stable doses of ≥500 mg of metformin with a duration ≥6 months and at stable doses for ≥2 months with a screening HbA1c ≥7.0% and ≤10.5%.
Who cannot join
- History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic or neurological disease, including any acute illness or major surgery within the major 3 months
- A sitting BP after resting for 5 minutes > 160mm Hg systolic or > 100 mm Hg diastolic or an apical pulse rate <50 or >100 beats per minute.
- Evidence of abnormality on the screening visit ECG, or a history of known arrhythmia or prolonged QTcF pr prolonged QRS interval
- Liver function test results elevated > 2.0-fold above the ULN for gamma glutamyl transferase, alkaline phosphatase, aspartate aminotransferase or alanine aminotransferase. Bilirubin above the ULN
- Estimated glomerular filtration rate < 60mL/min/1.73 m2 body surface area
- Known hypersensitivity to any of the study drug ingredients
- Any other condition or prior therapy that would make the participant unsuitable for this study
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Anaheim Clinical Trials
Anaheim, California, 92801
ProSciento, Inc
Chula Vista, California, 91911
QPS Miami Research Associates
Miami, Florida, 33143
Progressive Medical Research
Port Orange, Florida, 32127
About this study
Official title: A Phase 1b/2a, Randomized, Double-blind, Placebo-controlled, Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Ascending Doses of GSBR-1290 in Adult Overweight or Obese Healthy Subjects and in Subjects With Type 2 Diabetes Mellitus on Metformin
This study will evaluate safety, tolerability, pharmacokinetic (PK) profile, and pharmacodynamic (PD) effects on GSBR-1290 in healthy overweight/obese volunteers (HOV) and Type 2 Diabetes Mellitus on Metformin (T2DM) This study includes 5 planned cohorts. Participants will receive multiple-ascending doses of GSBR-1290 or Placebo from Day 1 to Day 84
- Conditions
- Overweight or Obesity, Type2 Diabetes Mellitus
- Being tested
- GSBR-1290, Placebo
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GSBR-1290Drug
Patients will receive GSBR-1290 or matching Placebo
PlaceboDrug
Patients will receive GSBR-1290 or matching Placebo
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Patients will receive once daily doses of study drug (GSBR-1290 or Placebo) for a total of 4 weeks Receives: Drug: GSBR-1290; Drug: Placebo |
| Cohort 2 | Experimental | Patients will receive once daily doses of study drug (GSBR-1290 or Placebo) for a total of 4 weeks Receives: Drug: GSBR-1290; Drug: Placebo |
| Cohort 3 | Experimental | Patients will receive once daily doses of study drug (GSBR-1290 or Placebo) for a total of 4 weeks Receives: Drug: GSBR-1290; Drug: Placebo |
| Cohort 4 | Experimental | HOV participants (Cohort 4) will receive multiple-ascending doses of GSBR-1290 or placebo for a total of 12 weeks Receives: Drug: GSBR-1290; Drug: Placebo |
| Cohort 5 | Experimental | Participants with T2DM(Cohort 5) will be randomized to placebo, low-dose, or high-dose arms. Participants in the low-dose, high-dose or placebo arms will receive multiple-ascending doses for 12 weeks Receives: Drug: GSBR-1290; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence, severity and relationship of AE/SAE, vital signs, laboratory measures and ECG to assess safety and tolerability of multiple oral doses of GSBR-1290 in HOV and T2DM
Measured: 42 days
Secondary outcomes (4)
Analysis of Cmax at specified timepoints predose and postdose to calculate PK parameters
Measured: 31 days
Analysis of Tmax at specified timepoints predose and postdose to calculate PK parameters
Measured: 31 days
Analysis of AUC at specified timepoints predose and postdose to calculate PK parameters
Measured: 31 days
Identification of GSBR-1290 metabolites following oral administration of multiple doses in plasma
Measured: 31 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2023
- Study start9 Jan 2023
- Primary completion11 Apr 2024
- Study completion11 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight or 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
- 142 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
- NCT05762471
- Sponsor's protocol ID
- GSBR-1290-02
- Status last verified
- Apr 2024
- First submitted
- 25 Jan 2023
- Last updated
- 25 Apr 2024
- 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 the specific research question in an approved data sharing request
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b/2a, Randomized, Double-blind, Placebo-controlled, Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Ascending Doses of GSBR-1290 in Adult Overweight or Obese Healthy Subjects and in Subjects With Type 2 Diabetes Mellitus on Metformin
- ClinicalTrials.gov ID
- NCT05762471
- Acronym / sponsor ID
- GSBR-1290-02
- Conditions
- Overweight or Obesity, Type2 Diabetes Mellitus
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 9 Jan 2023 (actual)
- Primary completion
- 11 Apr 2024 (actual)
- Study completion
- 11 Apr 2024 (actual)
- First posted
- 9 Mar 2023 (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 will evaluate safety, tolerability, pharmacokinetic (PK) profile, and pharmacodynamic (PD) effects on GSBR-1290 in healthy overweight/obese volunteers (HOV) and Type 2 Diabetes Mellitus on Metformin (T2DM) This study includes 5 planned cohorts. Participants will receive multiple-ascending doses of GSBR-1290 or Placebo from Day 1 to Day 84
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 |
|---|---|---|
| Cohort 1 | Experimental | Drug: GSBR-1290, Drug: PlaceboPatients will receive once daily doses of study drug (GSBR-1290 or Placebo) for a total of 4 weeks |
| Cohort 2 | Experimental | Drug: GSBR-1290, Drug: PlaceboPatients will receive once daily doses of study drug (GSBR-1290 or Placebo) for a total of 4 weeks |
| Cohort 3 | Experimental | Drug: GSBR-1290, Drug: PlaceboPatients will receive once daily doses of study drug (GSBR-1290 or Placebo) for a total of 4 weeks |
| Cohort 4 | Experimental | Drug: GSBR-1290, Drug: PlaceboHOV participants (Cohort 4) will receive multiple-ascending doses of GSBR-1290 or placebo for a total of 12 weeks |
| Cohort 5 | Experimental | Drug: GSBR-1290, Drug: PlaceboParticipants with T2DM(Cohort 5) will be randomized to placebo, low-dose, or high-dose arms. Participants in the low-dose, high-dose or placebo arms will receive multiple-ascending doses for 12 weeks |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Provided evidence of a signed consent
- Age ≥ 18 and ≤ 75 years
- Healthy overweight/obese adult men and women with body mass index ≥ 27 and ≤ 40 kg/m2
- No nicotine use
- Have a suitable venous access for blood sampling
Key exclusion criteria (7 listed)
- History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic or neurological disease, including any acute illness or major surgery within the major 3 months
- A sitting BP after resting for 5 minutes > 160mm Hg systolic or > 100 mm Hg diastolic or an apical pulse rate <50 or >100 beats per minute.
- Evidence of abnormality on the screening visit ECG, or a history of known arrhythmia or prolonged QTcF pr prolonged QRS interval
- Liver function test results elevated > 2.0-fold above the ULN for gamma glutamyl transferase, alkaline phosphatase, aspartate aminotransferase or alanine aminotransferase. Bilirubin above the ULN
- Estimated glomerular filtration rate < 60mL/min/1.73 m2 body surface area
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 |
|---|---|---|
| GSBR-1290Patients will receive GSBR-1290 or matching Placebo | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4, Cohort 5 |
| PlaceboPatients will receive GSBR-1290 or matching Placebo | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4, Cohort 5 |
Primary outcome
Incidence, severity and relationship of AE/SAE, vital signs, laboratory measures and ECG to assess safety and tolerability of multiple oral doses of GSBR-1290 in HOV and T2DM
Time frame: 42 days
4 secondary outcomes
Analysis of Cmax at specified timepoints predose and postdose to calculate PK parameters
Time frame: 31 days
Analysis of Tmax at specified timepoints predose and postdose to calculate PK parameters
Time frame: 31 days
Analysis of AUC at specified timepoints predose and postdose to calculate PK parameters
Time frame: 31 days
Identification of GSBR-1290 metabolites following oral administration of multiple doses in plasma
Time frame: 31 days
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 25 Apr 2024.
- Individual participant dataSharing planned: Yes. De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
Related trials for Overweight or Obesity
Active, not recruiting
Optimal Digital Weight Loss Treatment for Rural Individuals
Overweight and Obesity
Active, not recruiting
A Pilot Factorial Trial of an Integrated Lifestyle Intervention
Physical Inactivity, Overweight and Obesity
Active, not recruiting
Developing a Learning COmmunity to Increase eNgagemeNt and Enrollment in Cardiovascular Clinical Trials (CONNECT)
Cardiovascular Diseases, Hypertension
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
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.
4 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 GSBR-1290 in people with Overweight or Obesity and Type2 Diabetes Mellitus, run by Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics at 4 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 9 inclusion and 7 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 25 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 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?
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?
Incidence, severity and relationship of AE/SAE, vital signs, laboratory measures and ECG to assess safety and tolerability of multiple oral doses of GSBR-1290 in HOV and T2DM (time frame: 42 days). 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 25 Apr 2024.