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20 recruiting in KY
Recruiting

Efficacy and Safety of Eloralintide (LY3841136) in Participants With Osteoarthritis Knee Pain and Obesity or Overweight

Osteoarthritis · Overweight or Obesity

The YDAN master protocol will support two independent studies, J3R-MC-YOA1 and J3R-MC-YOA2. Each study will investigate how well and safely Eloralintide (LY3841136) works in adults with obesity or overweight who have osteoarthritis (OA) of the knee with pain. Participation in the study will last about 75 weeks, including screening.

Louisville, KY18+ yrsAll genders
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Mitigation of Cardiovascular Disease Risks in Children With Extreme Obesity

Obesity and Overweight · Obese Adolescents · Weight Management

The goal of this clinical trial is to learn if the drug semaglutide changes markers of disease risk as it relates to weight in children ages 12-15 years old who are obese (class 2 or 3). The main questions it aims to answer are: * How do the rate of weight loss, body mass index (BMI), body composition, heart structure and function, and exercise ability interact with one another in the study population at enrollment? * How do risk markers of disease change over the study in the study participants who are given semaglutides to help with weight loss? * Are there differences in the above factors between males and females and are there key factors to help improve the outcomes? Participants will be given semaglutide for this study. During the course of the study, participants will: * have two cardiac MRI scans OR two cardiac echocardiograms (one before starting semaglutide and one around 12 months after taking the drug) * have body composition and fitness levels assessed twice (before semaglutide and around 12 months after taking it) and have urine specific gravity (USG) measured * have extra blood drawn when labs their doctor orders are already being drawn (once at the beginning of the study, once around 6 months after enrollment, and once at the end of the study) * have follow up visits with the study doctor * be asked to take a pregnancy test if they are female and have started menstruation

Lexington, KY12–17 yrsAll genders
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A Study to Investigate the Effectiveness of Tirzepatide (LY3298176) Following Initiation of Ixekizumab (LY2439821) in Participants With Moderate-to-Severe Plaque PsO and Obesity or Overweight in Clinical Practice (TOGETHER AMPLIFY-PsO)

Psoriasis · Overweight or Obesity

The main purpose of this study is to assess the effectiveness of adding tirzepatide to ixekizumab therapy in standard clinical practice in participants with moderate-to-severe plaque PsO and obesity or overweight with at least 1 weight-related comorbidity. The study will last up to 12 months.

Bowling Green, KY18+ yrsAll genders
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A Clinical Study to Evaluate the Effects of Enicepatide (RO7795068) in Participants With Obesity or Overweight Without Type 2 Diabetes

Obesity or Overweight

The purpose of this study is to assess the efficacy and safety of enicepatide, a dual glucagon like peptide-1 (GLP-1)/glucose-dependent insulinotropic polypeptide (GIP) receptor agonist (RA), at multiple doses compared with placebo for weight management in participants without Type 2 diabetes mellitus (T2DM) who have obesity or overweight with at least one weight-related comorbidity.

Louisville, KY18+ yrsAll genders
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Mirikizumab and Tirzepatide Administered in Adult Participants With Moderately to Severely Active Crohn's Disease and Obesity or Overweight

Crohn's Disease · Obesity or Overweight

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.

Louisville, KY18–70 yrsAll genders
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A Phase 2 Study to Evaluate the Pharmacodynamics, Safety and Tolerability of BGE-102 in Participants With Obesity and Cardiovascular Risk Factors

Obesity and Cardiovascular Risk

The purpose of this study is to learn about the effects of BGE-102 on blood biomarkers including hsCRP, which is a lab value used to measure inflammation. BGE-102 decreases inflammation which may improve obesity and cardiovascular health. Participants will receive either BGE-102 or placebo. This study will be checking safety and tolerability of BGE-102.

Lexington, KY18+ yrsAll genders
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A Study to Investigate Weight Management With Macupatide and Eloralintide, Alone or in Combination, in Adult Participants With Obesity or Overweight

Overweight · Obesity

The main purpose of this study, performed under the master protocol W8M-MC-CWMM (NCT06143956), is to examine the body weight-lowering efficacy and safety of macupatide plus eloralintide compared with placebo in participants with obesity or overweight and without type 2 diabetes. Participation will last about 64 weeks.

Louisville, KY18–75 yrsAll genders
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Maridebart Cafraglutide in Heart Failure With Preserved or Mildly Reduced Ejection Fraction and Obesity

Heart Failure With Preserved Ejection Fraction · Heart Failure With Mildly Reduced Ejection Fraction · Obesity

This trial will examine if maridebart cafraglutide as an adjunct to standard of care will lead to a reduction in heart failure (HF) events such as HF hospitalizations and urgent HF visits, cardiovascular (CV) deaths and improvement in HF symptoms in participants with HF with preserved ejection fraction (HFpEF) and HF with mildly reduced ejection fraction (HFmrEF) who are obese. This is a phase 3, global, multicenter, 2-part trial with a double-blind period and an open-label extension (OLE). The trial is event-driven, and Part 1 will conclude when approximately 850 primary endpoint events have occurred.

Lexington, KY18–99 yrsAll genders
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Mirikizumab Administered at the Same Time as Tirzepatide in Adult Participants With Moderately to Severely Active Ulcerative Colitis and Obesity or Overweight: Phase 3b Study

Ulcerative Colitis · Obesity or Overweight

The main purpose of this study is to show whether in these individuals, treatment with both mirikizumab and tirzepatide, compared with treatment with mirikizumab and placebo, leads to decrease or disappearance of UC symptoms, and loss of at least one-tenth of the overall body weight. Participation in this study will last up to 61 weeks, including 52 weeks of treatment.

Louisville, KY18–70 yrsAll genders
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A Master Protocol Study (LY900038) of Multiple Intervention-Specific-Appendices (ISAs) in Adult Participants With Obesity or Overweight

Obesity · Overweight

The purpose of this Phase-2 chronic weight management master protocol (CWMM) is to create a framework to evaluate the safety and efficacy of various investigational interventions for chronic weight management with intervention-specific appendices (ISAs). The CWMM establishes entry criteria for newly enrolled participants across the master and the ISAs. The ISAs may start independently of other ISAs as interventions become available for clinical testing. The results for the CWMM screening record will be reported when all the ISA's complete.

Louisville, KY18–75 yrsAll genders
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A Research Study to Look at How Two Different Doses of CagriSema and One Dose of Semaglutide Help People Living With Obesity With or Without Type 2 Diabetes Lose Weight

Obesity · Type 2 Diabetes

This clinical study is testing how the study medicine CagriSema helps people living with obesity, with or without type 2 diabetes (T2D), lose weight. The purpose of the study is to find out how safe and effective CagriSema is for body weight loss in these participants. Participants will receive either CagriSema or semaglutide, and which treatment participants receive is decided by chance. CagriSema is a new study medicine being tested, while semaglutide is a medicine that doctors can already prescribe. The study will last for about 83 weeks

Lexington, KY18+ yrsAll genders
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Recruiting

AMAZE 6: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight and Knee Osteoarthritis Lose Weight and Reduce Pain

Obesity · Overweight · Osteoarthritis, Knee

This study is being done to look at the safety and effect of NNC0487-0111 in people with excess body weight and knee osteoarthritis when compared to placebo. There are 2 study treatments in this study taken as injections under the skin once a week. Participants will either get NNC0487-0111, (the treatment being tested) or Placebo (a treatment that has no active medicine in it). Which treatment participants get is decided by chance.

Louisville, KY18+ yrsAll genders
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2024 Tirzepatide-Bariatric Surgery

Obesity and Obesity-related Medical Conditions · Bariatric Surgery

This clinical trial will test whether preoperative tirzepatide treatment improves outcomes after bariatric surgery. The outcome of this study could impact therapeutic guidelines for the multimodal treatment of obesity. The major objectives are: 1. To evaluate whether pre-operative tirzepatide treatment reduces tissue and circulating inflammatory markers at the time of surgery. 2. To establish the relationship of these changes with postoperative improvements in weight loss, metabolic and inflammatory profiles, comorbidity resolution (glycemic control, blood pressure, lipid profile), and 30-day surgical complications. Researchers will compare data from patients taking tirzepatide to data from patients not taking tirzepatide before their planned bariatric surgery to see if tirzepatide reduces inflammation and improves health outcomes after bariatric surgery. Participants will: Take or not take tirzepatide, depending on what study group they are in, once a week for 3 months. Visit the endocrine clinic once a month for 3 months to be prescribed the drug and for checkups regarding side effects due to the drug. Keep a diary to document taking the drug and any side effects. Continue with their planned bariatric surgery and post-surgery follow-ups according to their healthcare provider.

Lexington, KY18+ yrsAll genders
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Recruiting

A Study to Learn About the Medicine Ponsegromab in Adults With Cancer of the Pancreas Which Has Spread and Caused Significant Body Weight Loss and Fatigue

Cachexia · Metastatic Pancreatic Ductal Adenocarcinoma

Study to investigate the efficacy, safety and tolerability of systemic chemotherapy plus ponsegromab versus systemic chemotherapy plus placebo for the first-line treatment in adult participants with cachexia and metastatic pancreatic ductal adenocardinoma.

Lexington +more, KY18+ yrsAll genders
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The Effects of Mirabegron and Tadalafil on Glucose Tolerance in Prediabetics

Pre-diabetes · Obesity

The investigator hypothesizes that treatment with the ß3 agonist mirabegron results in improved glucose metabolism, including a reversal of prediabetes in obese, insulin-resistant human research participants, and this is further improved by combination therapy with tadalafil. The investigator will comprehensively analyze glucose homeostasis in prediabetic patients treated for 14 weeks with mirabegron, tadalafil or both drugs as compared to a placebo.

Lexington, KY35–65 yrsAll genders
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