ClinicalTrials.gov19 days agoNeutral
Status: RECRUITING | Phase: PHASE2 | Sponsor: University of Southern California | Conditions: Smoking Cessation, Smoking Behaviors | Interventions: Tirzepatide, Placebo | This multi-site clinical trial will generate data on the efficacy of tirzepatide for smoking cessation and associated outcomes (e.g., post-cessation weight gain) in treatment-seeking people who smoke (PWS) with overweight or obesity. A sample of 300 treatment-seeking people who smoke with body mass index of 25 kg/m2 or greater will be recruited from four geographic sites (University of Southern California, Yale University, University of Chicago, and University of Colorado Anschutz Medical Campus
clinical_trial
ClinicalTrials.gov19 days agoNeutral
Status: RECRUITING | Phase: PHASE2 | Sponsor: T. John Winhusen, PhD | Conditions: Opioid Use Disorder, Opioid Use Disorder, Moderate, Opioid Use Disorder, Severe | Interventions: Tirzepatide, Placebo | The primary objective of this research study is to evaluate the effect of tirzepatide, relative to placebo, as an adjunct to BUP on retention, substance use, and sleep outcomes in individuals with OUD.
clinical_trialresearch
ClinicalTrials.gov19 days agoNeutral
Status: RECRUITING | Phase: PHASE2 | Sponsor: BioMarin Pharmaceutical | Conditions: Idiopathic Short Stature | Interventions: Vosoritide Injection, Human Growth Hormone, Placebo | The purpose of this study is to evaluate i) the effect of multiple doses of vosoritide and ii) the effect of the therapeutic dose of vosoritide compared to human growth hormone (hGH)(hGH; only in the United States), in children with idiopathic short stature (ISS).
clinical_trialresearch
ClinicalTrials.gov19 days agoNegative
Status: RECRUITING | Phase: PHASE3 | Sponsor: Eli Lilly and Company | Conditions: Metabolic Dysfunction-Associated Steatotic Liver Disease | Interventions: Tirzepatide, Retatrutide, Placebo | The main purpose of the SYNERGY-OUTCOMES study is to find out whether retatrutide and tirzepatide can prevent major adverse liver outcomes (MALO) in people with high-risk metabolic dysfunction-associated steatotic liver disease (MASLD). The study will enroll adults who have MASLD based on non-invasive tests (NITs), which indicate they are more likely to develop MALO. Participants will be randomly assigned within a Master Protocol to receive either retatrutide (N1T-MC-RT01), tirzepatide (N1T-MC-T
clinical_trialsafetyresearch
ClinicalTrials.gov19 days agoNeutral
Status: RECRUITING | Phase: PHASE2 | Sponsor: Eli Lilly and Company | Conditions: Type 2 Diabetes | Interventions: LY3457263, Placebo | The purpose of this study is to measure the change in hemoglobin A1c (HbA1c) with LY3457263 compared with placebo in participants with type 2 diabetes who are not at HbA1c goal when treated with a stable dose of semaglutide or tirzepatide. Participation in the study will last about 9 months.
clinical_trialresearch
ClinicalTrials.gov19 days agoNeutral
Status: RECRUITING | Phase: PHASE1 | Sponsor: Vanderbilt University | Conditions: Obesity, Insulin Resistance, Hypertension | Interventions: Angiotensin-(1-7), Saline | The overall purpose of this study is to learn more about the metabolic effects of angiotensin-(1-7) in the insulin resistant state associated with obesity. Pharmacologic approaches to increase angiotensin-(1-7) levels or its actions are currently in development for treatment of metabolic-related diseases such as obesity and type II diabetes, based on findings from animal studies. It is unclear if this peptide contributes to the regulation of metabolism in humans. The investigators will test if a
clinical_trialresearch
ClinicalTrials.gov19 days agoNeutral
Status: NOT_YET_RECRUITING | Phase: PHASE4 | Sponsor: Alain Dagher | Conditions: Class I/II Obesity | Interventions: semaglutide | The goal of this clinical trial is to learn about the nature of brain abnormalities associated with excess body fat in healthy adults aged 35-55. The main questions it aims to answer are:
* Will excessive fat be associated with brain abnormalities on MRI measures?
* Will weight loss change brain health on MRI measures?
Participants will:
* Self-administer study drug, semaglutide, once a week for 80 weeks
* Complete metabolic and basic body measurements
* Complete cognitive, mood, and dietary
clinical_trialresearch
ClinicalTrials.gov19 days agoNeutral
Status: NOT_YET_RECRUITING | Phase: PHASE2 | Sponsor: Rutgers, The State University of New Jersey | Conditions: Endometrial Cancer | Interventions: Tirzepatide, LNG-IUD plus tirzepatide | This study is looking for a better way to treat pre-cancer or early-stage cancer in the lining of the uterus in women who are also overweight.
Everyone in the study will receive the standard treatment, a Progesterone IUD (LNG-IUD). This device is put in the uterus and releases hormones to help fight the disease. We will add a new medicine, Tirzepatide, for some people. Tirzepatide is a shot that helps with weight loss and overall health. You will be placed into one of two groups by chance (like
clinical_trialsafetyresearch
ClinicalTrials.gov19 days agoNeutral
Status: COMPLETED | Phase: PHASE4 | Sponsor: Eli Lilly and Company | Conditions: Type 2 Diabetes | Interventions: Tirzepatide | The main purpose of the study is to investigate whether tirzepatide can be effectively started before Ramadan and used per label in participants with Type 2 Diabetes during the fasting month.
clinical_trialresearch
BioPharma Dive21 days agoNeutral
<figure><div><img src="https://imgproxy.divecdn.com/LowZC1MwT9Eoh9-eh6IIeyJiBwTqUfwuBerLTmPY2L8/g:ce/rs:fill:1600:900:1/Z3M6Ly9kaXZlc2l0ZS1zdG9yYWdlL2RpdmVpbWFnZS9HZXR0eUltYWdlcy0yMTg3NDY5NzM2LmpwZw==.webp" /></div></figure><p>The biotechnology startup emerged from stealth with a peptide drug it claims to have the potential to reverse lung scarring in people with idiopathic pulmonary fibrosis.</p>
general
ClinicalTrials.gov21 days agoNeutral
Status: RECRUITING | Phase: PHASE3 | Sponsor: Eli Lilly and Company | Conditions: Crohn's Disease, Obesity or Overweight | Interventions: Mirikizumab, Mirikizumab, Tirzepatide | The main purpose of this study is to evaluate the efficacy and safety of mirikizumab and placebo compared with mirikizumab and concomitantly administered tirzepatide in adult participants with moderately to severely active CD and obesity, or overweight.
The maximum duration of this study is up to 61 weeks.
clinical_trialresearch
ClinicalTrials.gov21 days agoNeutral
Status: NOT_YET_RECRUITING | Phase: NA | Sponsor: Eighth Affiliated Hospital, Sun Yat-sen University | Conditions: Obesity Type 2 Diabetes Mellitus | Interventions: Fecal microbiota transplantation (FMT), Semaglutide (1 Mg Dose), Calorie-restricted diet | Investigation of the efficacy of fecal microbiota transplantation added to calorie-restricted diet and semaglutide versus calorie-restricted diet and semaglutide alone for weight loss and metabolic improvement in patients with moderate to severe obesity and type 2 diabetes mellitus.
clinical_trial
ClinicalTrials.gov21 days agoNeutral
Status: ENROLLING_BY_INVITATION | Phase: N/A | Sponsor: Novo Nordisk A/S | Conditions: Type 2 Diabetes | Interventions: | The study is testing the incidence of MACE and incidence of renal events between Ozempic® users and users with other anti-diabetic medications in T2D patients. This is a retrospective study, and participants had received Ozempic or any other anti-diabetic medications.
clinical_trialresearch
ClinicalTrials.gov21 days agoPositive
Status: RECRUITING | Phase: PHASE2 | Sponsor: Cascade Pharmaceuticals, Inc | Conditions: Metabolic Dysfunction-associated Steatohepatitis (MASH), Obesity | Interventions: semaglutide, CS060380, Placebo | this study is looking at a new investigational medicine called CS060380, when used together with semaglutide, in adults who have both metabolic dysfunction-associated steatohepatitis (MASH) and obesity. MASH is a condition where too much fat builds up in the liver, leading to inflammation and damage. Obesity is a major risk factor for this condition.
This is a Phase II clinical trial, which means we are testing the medicine to see if it works and is safe. The study will last up to 54 weeks, whi
clinical_trialsafetyresearch
ClinicalTrials.gov21 days agoNeutral
Status: RECRUITING | Phase: PHASE1 | Sponsor: National Institute on Alcohol Abuse and Alcoholism (NIAAA) | Conditions: Alcohol Use Disorder (AUD) | Interventions: Tirzepatide, Placebo, [11C]raclopride plus drug | Background:
Glucagon-like peptide 1 (GLP-1) agonist drugs are used to treat diabetes and aid weight loss. They may also help reduce cravings for drugs and alcohol. Researchers want to know if a GLP-1 drug (tirzepatide) can lessen the urge to drink in people with alcohol use disorder (AUD).
Objective:
To learn how the brains of people with AUD respond to a GLP-1 drug.
Eligibility:
People aged 21 to 65 years with AUD who are non-treatment seeking. They must be enrolled in protocol 14-AA-0181.
clinical_trial
ClinicalTrials.gov22 days agoNeutral
Status: ACTIVE_NOT_RECRUITING | Phase: PHASE3 | Sponsor: Novo Nordisk A/S | Conditions: Cardiovascular Disease | Interventions: Cagrilintide, Semaglutide, Placebo | This study will look at the effects of CagriSema on cardiovascular events (for example heart attack and stroke) in people living with cardiovascular disease. Participants will either get CagriSema or a dummy medicine (also called "placebo") which has no effect on the body. Which treatment participants will get will be decided by chance. Participant's chance of getting CagriSema or placebo is the same. Participants will inject the study medicine once a week. The study medicine will be injected br
clinical_trialresearch
ClinicalTrials.gov22 days agoNeutral
Status: NOT_YET_RECRUITING | Phase: PHASE2 | Sponsor: Victor Chang Cardiac Research Institute | Conditions: Type 1 Diabetes Mellitus | Interventions: Tirzepatide 2.5mg weekly, Placebo injection (normal saline) | This study will examine the effects of Tirzepatide (TZP), a glucagon-like peptide 1 (GLP1) - gastric inhibitory peptide (GIP) co-agonist, on metabolism in type 1 diabetes (T1D). Research participants with T1D will undergo measures of insulin sensitivity, and hormone levels post-meal, post-hypoglycemia and during the overnight period. These measures will be performed prior to, and after 6 weeks of treatment with TZP or placebo.
clinical_trialresearch
ClinicalTrials.gov22 days agoNeutral
Status: ENROLLING_BY_INVITATION | Phase: PHASE2, PHASE3 | Sponsor: Vanderbilt University Medical Center | Conditions: Severe Obesity, Obesity, BMI Greater Than 30 | Interventions: Tirzepatide, Standard of Care post-gastric bypass | The goal of this pilot clinical trial is to determine the effectiveness of Tirzepatide in patients with persistent obesity (BMI \> 30) 12 months after bariatric surgery (Roux-en-Y Gastric Bypass). The investigators also aim to determine the frequency of side effects with Tirzepatide in this patient population. Patients who take tirzepatide 12 months after bariatric surgery will be compared to patients who continue with the current standard of care for patients who have previously undergone Ga
clinical_trial
ClinicalTrials.gov22 days agoNeutral
Status: RECRUITING | Phase: PHASE4 | Sponsor: Las Rías Medical Center | Conditions: Obesity, Diabetes Mellitus, Type 2 | Interventions: Tirzepatide (LIPOLESS de Laboratorio de Productos Eticos C.E.I.S.A.) | This is a prospective cohort study evaluating the efficacy, safety, and tolerability of tirzepatide under real-world conditions in the Paraguayan population. The study includes two cohorts: Cohort 1 consists of adults with obesity (BMI ≥30 kg/m²) without type 2 diabetes mellitus (T2DM), and Cohort 2 consists of adults with T2DM with or without obesity. Each cohort will enroll 80 participants (160 total). All participants will receive tirzepatide as part of their standard clinical care and will b
clinical_trialresearch
ClinicalTrials.gov22 days agoNeutral
Status: COMPLETED | Phase: N/A | Sponsor: Novo Nordisk A/S | Conditions: Diabetes Mellitus, Type 2 | Interventions: semaglutide | The purpose of this study is to assess the safety of long-term treatment with Ozempic® in patients with type 2 diabetes mellitus. People will get Ozempic® as prescribed by their doctor. People will be in this study about 3 years. People above the age of 18 will be asked to fill in the quality of life (QOL) questionnaire (the QOL questionnaire is for the assessment of the influence of diabetes treatment on people's life). There is a possibility that people's blood sample would be provided to Novo
clinical_trialresearch
ClinicalTrials.gov22 days agoPositive
Status: ACTIVE_NOT_RECRUITING | Phase: PHASE2 | Sponsor: University of Minnesota | Conditions: Obesity, Childhood | Interventions: Intensive Behavioral Program, Semaglutide and Behavioral Program | The prevalence of adolescent severe obesity is at an all-time high in the United States and the refractory nature of this disease has led to a serious and challenging conundrum in terms of how to provide effective, safe, scalable, and durable treatments without placing undue strain on the healthcare system. Clinical practice guidelines recommend behavioral interventions as the primary strategy for all ages and classes of obesity - moderate to severe. In 2017, the U.S. Preventive Services Task Fo
clinical_trial
ClinicalTrials.gov22 days agoNeutral
Status: RECRUITING | Phase: NA | Sponsor: GT Metabolic Solutions, Inc. | Conditions: Obesity (Disorder), Obesity & Overweight, Type 2 Diabetes (T2DM) | Interventions: Magnet System, Semaglutide | Compare use of the Magnet System in side-to-side duodeno-ileostomy (Surgery) with semaglutide (Medication).
clinical_trial
ClinicalTrials.gov22 days agoPositive
Status: RECRUITING | Phase: PHASE2 | Sponsor: Novo Nordisk A/S | Conditions: Diabetes Mellitus, Type 2 | Interventions: NNC0662-0419, Semaglutide, Placebo | This study is being done to look at the effect and safety of different doses of NNC0662-0419 in people living with type 2 diabetes when compared to placebo or semaglutide. The purpose of this clinical study is to find out if NNC0662-0419 is effective and safe for treating people living with type 2 diabetes. Participants will get either NNC0662-0419, semaglutide or placebo. Which treatment participants get is decided by chance. NNC0662-0419 is a new medicine which cannot be prescribed by doctors
clinical_trialresearch
ClinicalTrials.gov22 days agoNeutral
Status: COMPLETED | Phase: PHASE1 | Sponsor: Novo Nordisk A/S | Conditions: Obesity | Interventions: Cagrilintide, Semaglutide, Atorvastatin | This study will look at how CagriSema affects the blood levels of atorvastatin and warfarin. The study will look at the levels of warfarin and atorvastatin in the blood before the participant starts taking CagriSema and if this changes after the participant has taken CagriSema. The study will also investigate the effect of warfarin before and after the participant takes CagriSema and assess if the injection site affects the level of CagriSema in the blood. The study will last for about 8 months.
clinical_trialresearch
ClinicalTrials.gov22 days agoNeutral
Status: ACTIVE_NOT_RECRUITING | Phase: PHASE1 | Sponsor: Eli Lilly and Company | Conditions: Diabetes Mellitus, Type 2, Overweight, Obesity | Interventions: Tirzepatide | The purpose of this study is to evaluate how fasting and stopping the use of tirzepatide affects the amount of food and drink that stays in the stomach after a meal. Ultrasound will be used to check the stomach content after a test meal.
clinical_trialresearch
ClinicalTrials.gov22 days agoNeutral
Status: RECRUITING | Phase: PHASE3 | Sponsor: Eli Lilly and Company | Conditions: Obesity, Weight Gain | Interventions: Tirzepatide, Placebo | The goal of the study is to assess how tirzepatide impacts bodyweight and cardiovascular risk factors when used in conjunction with healthy nutrition and physical activity in adolescents with obesity and multiple weight related comorbidities. The study will last approximately 76 weeks and may include up to 23 visits.
Participants who have completed the primary 72-week GPIX study and have been off treatment for no more than 12 weeks (including the 4-week safety follow-up period), will have the o
clinical_trialsafetyresearch
ClinicalTrials.gov22 days agoNeutral
Status: RECRUITING | Phase: PHASE4 | Sponsor: Eli Lilly and Company | Conditions: Diabetes Mellitus, Type 2, Obesity, Overweight | Interventions: Tirzepatide | The main purpose of this study is to measure the safety and efficacy of tirzepatide in adult participants in India who have type 2 diabetes or who have obesity or overweight without type 2 diabetes. Participation in the study will last about 46 weeks.
clinical_trialresearch
ClinicalTrials.gov22 days agoNeutral
Status: NOT_YET_RECRUITING | Phase: PHASE1 | Sponsor: Novo Nordisk A/S | Conditions: Obesity, Overweight | Interventions: Cagrilintide D, Cagrilintide B and placebo semaglutide I | This clinical study is testing two versions of the study medicine cagrilintide. The purpose of the study is to compare these two versions to understand their effects in participants with overweight or obesity. Participants will receive either cagrilintide version D or cagrilintide version B, and which treatment participants receive is decided by chance. Participants will be in this clinical study for about 6 months.
clinical_trialresearch
ClinicalTrials.gov23 days agoPositive
Status: ACTIVE_NOT_RECRUITING | Phase: PHASE4 | Sponsor: Ali Aminian | Conditions: Obesity and Obesity-related Medical Conditions | Interventions: Bariatric Surgery, Semaglutide, Tirzepatide | The recent introduction of the new generation of anti-obesity medications (AOMs) will change the future of obesity treatment. These highly effective medications, such as high-dose semaglutide and tirzepatide, are hormone analogues that augment the incretin function and exert multiple physiological effects by activating glucagon-like peptide-1 (GLP-1) and/or glucose-dependent insulinotropic polypeptide (GIP) distributed in various organs. These medications provide an average of 15-22% weight redu
clinical_trial
ClinicalTrials.gov23 days agoNeutral
Status: COMPLETED | Phase: PHASE3 | Sponsor: Novo Nordisk A/S | Conditions: Overweight, Obesity | Interventions: Semaglutide, Placebo | This study will look at how the investigational dose of semaglutide works in helping people with excess body weight, to lose weight. This study will compare the weight loss in people taking semaglutide to people taking "dummy" medicine (placebo). The study will last for about 1 year. The participants will have 12 visits at the clinic and 3 remote visits by phone calls with the study doctor or staff.
clinical_trialresearch
ClinicalTrials.gov26 days agoNeutral
Status: RECRUITING | Phase: NA | Sponsor: Tri-Service General Hospital | Conditions: Obesity and Metabolic Syndrome | Interventions: Tirzepatide with lifestyle modification, Semaglutide with lifestyle modification | This randomized, open label, head to head clinical trial directly compares tirzepatide and semaglutide in adults with obesity and metabolic syndrome (N=120, age 20-65, 1:1 randomization). Participants undergo deep phenotyping at baseline, 6 months, and 12 months, including DXA (regional fat, lean mass, and BMD), MRI PDFF (liver fat), 7 site skinfold thickness, grip strength, fasting biochemistry, and AI processed 12 lead ECGs. Centralized biobanking of serum, plasma, and PBMCs enables targeted a
clinical_trial
ClinicalTrials.gov26 days agoNeutral
Status: ACTIVE_NOT_RECRUITING | Phase: N/A | Sponsor: University College Dublin | Conditions: Metabolic Disease, Obesity & Overweight | Interventions: semaglutide 1 mg weekly injection | Ingestion of food instigates the release of a battery of enteroendocrine peptide hormones that help control gut motility and digestive secretion. Peptide hormone products of the enteroendocrine L-cell and GLP-1 in particular, play multiple roles in relation to the regulation of pancreatic islet function and gastric emptying and the induction of satiety pathways in the central nervous system The mechanism of action of GLP-1 RAs on food intake reduction is mainly mediated through both peripheral a
clinical_trialresearch
ClinicalTrials.gov26 days agoNeutral
Status: ACTIVE_NOT_RECRUITING | Phase: PHASE1, PHASE2 | Sponsor: University of Yaounde 1 | Conditions: Obesity and Overweight, Appetite Regulation | Interventions: Dichrostachys glomerata, Cissus quadrangularia, Dextrin | Obesity is a global health crisis affecting over 2.3 billion individuals worldwide. This prospective study aims to evaluate the comparative effects of standardised Cissus quadrangularis extract (CQE) and Dichrostachys glomerata extract (DGE) on obesity-related parameters, focusing on their impact on glucagon-like peptide-1 (GLP-1) levels and dipeptidyl peptidase-4 (DPP-4) enzyme activity in obese subjects. Parameters such as GLP-1 levels, DPP-4 activity, food intake, satiety, body weight, blood
clinical_trialresearch
ClinicalTrials.gov26 days agoNeutral
Status: NOT_YET_RECRUITING | Phase: N/A | Sponsor: Noom Inc. | Conditions: Obesity & Overweight, Weight Loss, Preventative Health | Interventions: Noom Weight, Free Tier, Education-only control | This research program includes two coordinated prospective studies (FLOURISH and THRIVE) evaluating the real-world effectiveness of Noom's digital health programs on weight, cardiometabolic biomarkers, physiological health indicators, and program engagement.
FLOURISH is a 6-arm prospective cohort study comparing an Education-only control, Noom Weight, standard-dose compounded semaglutide, microdose compounded semaglutide, standard-dose tirzepatide (Noom Plus), and microdose tirzepatide (Noom Pl
clinical_trialresearch
ClinicalTrials.gov26 days agoNeutral
Status: ACTIVE_NOT_RECRUITING | Phase: N/A | Sponsor: Brigham and Women's Hospital | Conditions: Type 2 Diabetes, Heart Failure | Interventions: Tirzepatide, Semaglutide | This cohort study aims to assess the comparative effectiveness of tirzepatide versus semaglutide with respect to cardiovascular events in patients with type 2 diabetes and heart failure with preserved ejection fraction.
clinical_trialresearch
ClinicalTrials.gov26 days agoNeutral
Status: COMPLETED | Phase: N/A | Sponsor: Brigham and Women's Hospital | Conditions: Type 2 Diabetes | Interventions: Tirzepatide, Dulaglutide, Semaglutide | This cohort study was initiated to emulate the design of the SURPASS-CVOT trial using observational analogues of the trial design components in a study based on insurance claims data.
clinical_trialmarketresearch
Federal Registerabout 1 month agoNeutral
Notice. | The Food and Drug Administration (FDA, the Agency, or we) is evaluating substances that have been nominated for inclusion on a list of bulk drug substances (active pharmaceutical ingredients) for which there is a clinical need for outsourcing facilities to use in compounding (the 503B Bulks List). This notice identifies three bulk drug substances that FDA has considered and proposes not to include on the 503B Bulks List: semaglutide, tirzepatide, and liraglutide. Additional bulk drug substances nominated for inclusion on this list are under consideration and may be the subject of future notices.
regulatory
FDA Pressabout 1 month agoNeutral
FDA is proposing to exclude semaglutide, tirzepatide, and liraglutide from the 503B bulks list, finding no clinical need for outsourcing facilities to compound these drugs from bulk substances.
regulatory
Federal Registerabout 1 month agoNeutral
Notice; renewal of Federal advisory committee. | The Food and Drug Administration (FDA or the Agency) is announcing the renewal of the Pharmacy Compounding Advisory Committee by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the Pharmacy Compounding Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until the April 25, 2028, expiration date.
regulatorymarket
Federal Registerabout 1 month agoMixed
Notice. | The Food and Drug Administration (FDA or Agency) has determined that OZEMPIC (semaglutide) solution, 2 milligrams (mg)/1.5 milliliter (mL), was not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements.
regulatory
FDA Pressabout 2 months agoPositive
FDA is taking an initial step to advance treatment options for men’s health by encouraging sponsors of approved testosterone replacement therapy products to contact FDA for information if they are interested in pursuing a potential new indication for low libido in men with idiopathic hypogonadism.
regulatory
ClinicalTrials.gov3 months agoNeutral
Status: RECRUITING | Phase: PHASE2 | Sponsor: Hudson Biotech | Conditions: Hamstring Muscle Strain, Skeletal Muscle Injury | Interventions: Pentadecapeptide BPC 157, Placebo | This randomized, double-blind, placebo-controlled Phase 2 study evaluates whether pentadecapeptide BPC 157 (BPC-157), an investigational peptide, can speed structural healing and functional recovery after an acute grade II hamstring muscle strain. Participants will receive BPC 157 or placebo for 14 days in addition to a standardized rehabilitation program. The co-primary endpoints are time to return to unrestricted sport and change in MRI-assessed injury volume at Day 14.
clinical_trialresearch
ClinicalTrials.govover 10 years agoNeutral
Status: UNKNOWN | Phase: PHASE1 | Sponsor: PharmaCotherapia d.o.o. | Conditions: Healthy Volunteers | Interventions: Bepecin, Placebo | Phase I clinical trial in healthy volunteers to study safety and pharmacokinetics of BPC-157, a pentadecapeptide from gastric source.
clinical_trialresearch