🧪 TrialInsufficient
Registered Phase 3 interventional trial (completed). The purpose of this study is to evaluate the efficacy and safety of retatrutide in participants who have obesity or overweight (J1I-MC-GZBJ master protocol) including subsets of participants who have knee osteoarthritis (OA) (J1I-MC-GOA1) or who have obstructive sleep apnea (OSA) (J1I-MC-GSA1). This study will last about 89 weeks and will include up to 24 visits. Addendum (2) is optional and available to approximately 500 participants to continue treatment with retatrutide for up to an additional 24 weeks.
ClinicalTrials.gov · Jul 2023View trial ↗ 🧪 TrialInsufficient
Registered Phase 3 interventional trial (active not recruiting). The main purpose of this study is to evaluate the efficacy and safety of retatrutide once weekly in participants with obesity and established cardiovascular disease (CVD). The study will last about 113 weeks.
ClinicalTrials.gov · May 2023View trial ↗ 🧪 TrialInsufficient
Registered Phase 3 interventional trial (active not recruiting). This study will look at how well semaglutide helps children and teenagers losing weight. This will be tested by comparing the effect on body weight in children and teenagers taking semaglutide in comparison to placebo, a "dummy" medicine. In addition to taking the medicine, the child's parent and the child will have talks with study staff about healthy food choices, how to be more physically active and what your child can do to try to lose weight. The child will either get semaglutide or a "dummy" medicine. Which treatment the ch
ClinicalTrials.gov · Feb 2023View trial ↗ 🧪 TrialInsufficient
Registered Phase 1/Phase 2 interventional trial (active not recruiting). This is a single site, double-blind, placebo-controlled, crossover trial to quantify the effects of combination adjunctive therapy on glycemic control, ketogenesis during insulinopenia, insulin resistance, and diabetes burden and quality of life.
ClinicalTrials.gov · Jan 2023View trial ↗ 🧪 TrialInsufficient
Registered Phase 3 interventional trial (recruiting). The objective of this study is to compare the safety and efficacy of RGN-259 to placebo for the treatment of Neurotrophic Keratopathy (NK)
ClinicalTrials.gov · Sep 2022View trial ↗ 🧪 TrialInsufficient
Registered observational trial (enrolling by invitation). This is an observational, retrospective, cohort study using administrative insurance claims data. The aim of this non-interventional study (NIS) is to compare maternal, fetal and infant outcomes of women exposed to Wegovy during pregnancy to a reference population not exposed to Wegovy, so that participants and healthcare providers can make informed treatment decisions.
ClinicalTrials.gov · Aug 2022View trial ↗ 🧪 TrialInsufficient
Registered Phase 2 interventional trial (completed). A multicenter randomized double-blind placebo parallel control design was used in this study.60 subjects eligible for inclusion will be randomly assigned to either a low-dose (0.25ug/kg) medium-dose (0.5ug/kg) high-dose (2.0ug/kg) experimental drug group or a control group (placebo) at a ratio of 1:1:1:1.After randomization, subjects received the experimental drug or placebo once a day, intravenously, on day 2 to 7, 12 hours and 4 hours after PCI.Ninety days after PCI were observed.
ClinicalTrials.gov · Aug 2022View trial ↗ Insufficient
This study developed and validated an antibody-free analytical method for detecting prohibited growth hormone-releasing hormone (GHRH) analogues — specifically sermorelin, CJC-1293, a sermorelin metabolite, CJC-1295, and tesamorelin — in human urine samples. Instead of the conventional, labor-intensive immunoaffinity purification approach, the researchers used ultrafiltration alone to preconcentrate urine samples before analysis by nano liquid chromatography coupled with high-resolution tandem mass spectrometry (nanoLC-HRMS/MS). The method achieved limits of detection between 5 and 25 pg/mL and limits of identification between 25 and 50 pg/mL, with analyte recoveries of 59–115%. Robustness was demonstrated across over 200 injections. When compared directly to immunoaffinity purification, the ultrafiltration approach yielded similar sensitivity at lower cost and without requiring specialized antibodies. Stability experiments revealed that sermorelin and its metabolite degrade rapidly at temperatures above 4°C and at pH below 7, highlighting the critical importance of proper sample handling. The authors note the method could be extended to other emerging peptide drugs (≥ ~3 kDa) and their metabolites. A key limitation is that the study is an analytical methods validation paper rather than a clinical or pharmacological study; it does not assess biological effects or pharmacokinetics in human subjects.
Journal of pharmaceutical and biomedical analysis · Mar 2022DOI ↗ 🧪 TrialInsufficient
Registered Phase 2 interventional trial (active not recruiting). 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 Force (USPSTF) released updated scree
ClinicalTrials.gov · May 2021View trial ↗ 🧪 TrialInsufficient
Registered Phase 3 interventional trial (active not recruiting). Semaglutide is a medicine studied in patients with NASH. Semaglutide is a well-known medicine, which is already used by doctors to treat type 2 diabetes in many countries. Participants will either get semaglutide or a dummy medicine - which treatment participants get is decided by chance. Participants will need to inject themselves with medicine under the skin. Participants will need to do this once a week. The study will last for about 5 years. Participants will have up to 21 clinic visits and 9 phone calls with the clinical sta
ClinicalTrials.gov · Mar 2021View trial ↗ 🧪 TrialInsufficient
Registered observational trial (completed). The aim of this study is to evaluate whether exposure to semaglutide influences the risk of pancreatic cancer in patients with type 2 diabetes. This is achieved by estimating the risk of pancreatic cancer associated with semaglutide use as compared to use of other non-incretin antidiabetic drugs used at a similar stage as Ozempic® or Rybelsus® in the treatment of type 2 diabetes. A multi-national, non-interventional study based on health care data from Denmark, Sweden, and Norway is conducted covering the period 2018-2023. A cohort study design is us
ClinicalTrials.gov · Oct 2020View trial ↗ 🧪 TrialInsufficient
Registered Phase 1 interventional trial (completed). The objective of this study is to evaluate the safety, tolerance, pharmacokinetics and the potential immunological reaction of single intravenous recombinant human thymosin β4（NL005）or placebo 0.05, 0.25, 0.5, 2, 5, 12.5, 25μg/kg in Chinese healthy volunteers. 54 volunteers will be randomized to receive NL005 or placebo for 7 cohorts,administered iv by iv push on Day 1.
ClinicalTrials.gov · Sep 2020View trial ↗ 🧪 TrialInsufficient
Registered Phase 1 interventional trial (completed). The objective of this study is to evaluate the safety, tolerance, pharmacokinetics and the potential immunological reaction of single intravenous recombinant human thymosin β4（NL005）or placebo 0.5, 2.0,5.0μg/kg in Chinese healthy volunteers.30 volunteers will be randomly assigned to one of three groups to receive either NL005 or placebo for 10 consecutive days.
ClinicalTrials.gov · Sep 2020View trial ↗ 🧪 TrialInsufficient
Registered Phase 3 interventional trial (completed). The objective of this study is to compare the safety and efficacy of RGN-259 Ophthalmic Solution to placebo for the treatment of the signs and symptoms of dry eye.
ClinicalTrials.gov · May 2019View trial ↗ 🧪 TrialInsufficient
Registered observational trial (active not recruiting). Empagliflozin, a sodium glucose co-transporter 2 (SGLT-2) inhibitor, was launched as a treatment for type 2 diabetes mellitus (T2DM) in the U.S. in August 2014. In contrast with several previous cardiovascular outcomes trials, which failed to demonstrate an association with a higher or a lower risk of cardiovascular outcomes associated with members of other recently marketed antidiabetic classes, the EMPA-REG OUTCOME trial has shown that patients at high cardiovascular risk randomized to empagliflozin vs. placebo, were associated with a r
ClinicalTrials.gov · Dec 2017View trial ↗ 🧪 TrialInsufficient
Registered Phase 1 interventional trial (completed). The purpose of the study is to investigate the drug octreotide acetate in a new intranasal formulation and compare it to the FDA-approved subcutaneous (SC) injection formulation. The two octreotide acetate formulations will be evaluated following separate administrations for safety and tolerability including any side effects, the speed at which the drug is absorbed and eliminated in the body, and the ability of the drug to lower the levels of growth hormone (GH) and insulin-like growth factor 1 (IGF-1).
ClinicalTrials.gov · Jan 2017View trial ↗ 🧪 TrialInsufficient
Registered N/A interventional trial (completed). The purpose of this study was to validate the growth hormone releasing hormone (GHRH) plus arginine (GHRH+arg) stimulation test and it´s cut-off limits for diagnosis of adult growth hormone deficiency using the growth hormone (GH) Immulite 2000 Xpi assay calibrated against the IS 98/574 from the World Health Organization. A specific aim was to study the effect of gender and age on the peak GH response in the GHRH+arg test
ClinicalTrials.gov · Jan 2017View trial ↗ 🧪 TrialInsufficient
Registered Phase 3 interventional trial (unknown). 300 women with expected poor ovarian response (POR) undergoing in vitro fertilization or intra-cytoplasmic sperm injection (ICSI) will be randomly divided into 2 equal groups using computer generated random numbers. Group 1 will receive Dehydroepiandrosterone (DHEA) 25 mg ( DHEA 25mg, Natrol , USA) t.d.s daily for 12 weeks before starting IVF/ICSI cycle and a placebo similar to growth hormone (GH) daily from day 6 of stimulation until the day of human chorionic gonadotrophin (hCG) trigger. Group 2 will receive an oral placebo t.d.s. daily for
ClinicalTrials.gov · Apr 2016View trial ↗ 🧪 TrialInsufficient
Registered Phase 1 interventional trial (unknown). Phase I clinical trial in healthy volunteers to study safety and pharmacokinetics of BPC-157, a pentadecapeptide from gastric source.
ClinicalTrials.gov · Dec 2015View trial ↗ 🧪 TrialInsufficient
Registered Phase 2/Phase 3 interventional trial (completed). The objective of this study is to compare the safety and efficacy of RGN-259 Ophthalmic Solutions to placebo for the treatment of the signs and symptoms of dry eye.
ClinicalTrials.gov · Nov 2015View trial ↗