Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Waitlist Available
Sponsor: Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics
No Placebo Group
Prior Safety Data
Trial Summary
What is the purpose of this trial?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 GSBR-1290 in participants living with overweight or obesity with at least one weight-related comorbidity. Participants will be randomized to GSBR-1290 or placebo in a ratio of 3:1 within each Cohort receiving multiple-ascending, QD doses of GSBR-1290 or placebo in titration steps of 4 weeks duration for a total of 36 weeks of treatment.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the drug GSBR-1290 for obesity?
The research on combination therapies for obesity suggests that drugs affecting hormones like GLP-1, which are involved in digestion and appetite, have shown promise in treating obesity. This indicates that GSBR-1290, if it works similarly, might also be effective.
12345Eligibility Criteria
This trial is for adults with obesity (BMI ≥30) or overweight (BMI ≥27) who also have a weight-related health issue. They must not weigh less than 80 kg, have had certain obesity surgeries, diabetes, or significant weight changes recently.Inclusion Criteria
My BMI is 30 or higher, or it's above 27 with a condition related to obesity.
Exclusion Criteria
I have been diagnosed with diabetes.
I have lost or gained more than 5% of my body weight in the last 3 months.
My body weight is 80 kg or less.
Participant Groups
The study tests the effectiveness and safety of GSBR-1290 compared to a placebo in treating obesity. Participants will receive either the drug or placebo over 36 weeks with doses increasing every four weeks.
3Treatment groups
Experimental Treatment
Group I: Cohort 3Experimental Treatment1 Intervention
Participants will receive GSBR-1290 or Placebo administered orally.
Group II: Cohort 2Experimental Treatment1 Intervention
Participants will receive GSBR-1290 or Placebo administered orally.
Group III: Cohort 1Experimental Treatment1 Intervention
Participants will receive GSBR-1290 or Placebo administered orally.
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
ACCESS Research SiteMedford, OR
ACCESS Research SiteWilmington, NC
ACCESS Research SiteCincinnati, OH
ACCESS Research SiteValparaiso, IN
More Trial Locations
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Who is running the clinical trial?
Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure TherapeuticsLead Sponsor
References
Rate of Acute Hospital Admissions Before and After Roux-en-Y Gastric Bypass Surgery: A Population-based Cohort Study. [2019]To examine rates of acute inpatient hospital admissions patients undergoing Roux-en-Y gastric bypass (RYGB) surgery and a matched population-based comparison cohort.
Combination Therapies for Obesity. [2019]The objective of this review is to examine advances in the development of combination therapies for the treatment of obesity beyond diet or lifestyle interventions. Experimental combination pharmacotherapies include combinations of pramlintide and phentermine as well as amylin and bupropion-naltrexone. Incretin and pancreatic hormones generally inhibit upper gastrointestinal motor functions, and combinations showing efficacy in obesity are coadministration of glucagon-like peptide-1 (GLP-1) with glucagon, a unimolecular dual incretin of PEGylated GLP-1/GIP coagonist, the combination of GLP-1 and PYY3-36, and, in proof of concept studies, combined infusions of GLP-1, peptide YY, and oxyntomodulin. Among bariatric procedures, repeat intragastric balloon (IGB) treatments are more efficacious than IGB plus diet, and endoscopic intervention can enhance the effects of Roux-en-Y gastric bypass when weight regain occurs. A first trial has provided promising results with combination of IGB plus the GLP-1 analog, liraglutide, compared to the balloon alone. Thus, combination therapies for the treatment of obesity hold promise for introduction into clinical practice.
Health outcomes of gastric bypass patients compared to nonsurgical, nonintervened severely obese. [2021]Favorable health outcomes at 2 years postbariatric surgery have been reported. With exception of the Swedish Obesity Subjects (SOS) study, these studies have been surgical case series, comparison of surgery types, or surgery patients compared to subjects enrolled in planned nonsurgical intervention. This study measured gastric bypass effectiveness when compared to two separate severely obese groups not participating in designed weight-loss intervention. Three groups of severely obese subjects (N = 1,156, BMI >or= 35 kg/m(2)) were studied: gastric bypass subjects (n = 420), subjects seeking gastric bypass but did not have surgery (n = 415), and population-based subjects not seeking surgery (n = 321). Participants were studied at baseline and 2 years. Quantitative outcome measures as well as prevalence, incidence, and resolution rates of categorical health outcome variables were determined. All quantitative variables (BMI, blood pressure, lipids, diabetes-related variables, resting metabolic rate (RMR), sleep apnea, and health-related quality of life) improved significantly in the gastric bypass group compared with each comparative group (all P
[Clinical observation on acupuncture combined with diet control for treatment of simple obesity]. [2009]To search for an effective method for increasing the therapeutic effect on simple obesity.
[Effect of gastric bypass on the cardiovascular risk and quality of life in morbid obese patients]. [2014]To determine the prevalence of major comorbidities of morbidity obese patients and to evaluate the gastric bypass effect on the weight status, cardiovascular risk and quality of life in these patients.