Clinical Research Directory

Weight and Metabolic Management Study

The goal of this clinical trial is to learn whether elénzia CONTROL®, a nutritional supplement, can support weight management in adults who have either never used GLP-1 weight-loss medications or have recently stopped using them. The main question it aims to answer is: Does taking elénzia CONTROL® for 16 weeks help reduce body weight in adults who have never used GLP-1 medications or help prevent weight regain in adults who have recently stopped using them? The study will also look at changes in appetite, sugar cravings, mood, energy, diet, sleep, physical activity, stress, quality of life, and waist circumference. Researchers will compare elénzia CONTROL® with a placebo (a look-alike supplement that does not contain the active ingredients) to see whether elénzia CONTROL® has an effect on weight management. Participants will: Take two capsules of elénzia CONTROL® or placebo once a day, 30 minutes before their largest meal, for 16 weeks. Use a mobile app to record whether they have taken their capsules and complete study questionnaires and assessments. Measure and report their body weight and waist circumference throughout the study.

Cross-Sectional and Longitudinal Studies of "Pre-Diabetes" in the Pima Indians

Insulin resistance and a defect in early insulin secretion are risk factors for the development of type 2 diabetes mellitus. A recent longitudinal analysis which tracked the development of diabetes demonstrated that both insulin action and early insulin secretion deteriorate as individuals progress from normal to impaired glucose tolerance and then to diabetes. These results suggest that both inherent (apparent in normal glucose tolerant subjects who progress to diabetes and likely to have a genetic basis) and acquired (evident as individuals progress from NGT to IGT to diabetes and possibly environmental in origin) defects in insulin action and secretion contribute to the pathogenesis of type 2 diabetes. To identify the genetic and environmental determinants of diabetes we are continuing to determine: (1) if there are genes that segregate with metabolic risk factors for diabetes which might therefore be genetic markers for type 2 diabetes and (2) the mechanisms mediating genetic and environmental determinants of insulin resistance and impaired insulin secretion. \<TAB\> Volunteers for this study will be admitted to the clinical research ward where they will undergo several tests to determine body composition, oral and intravenous glucose tolerance and in vivo insulin action. In addition, in selected subjects, adipose and/or skeletal muscle tissue will be obtained by percutaneous biopsy for in vitro studies of gene expression and insulin action in these tissues. A transformed lymphocyte cell line will be established for each subject as a permanent source of DNA for genetic studies. Genetic markers for type 2 diabetes and insulin resistance will be sought by typing each individual at positional and functional candidate loci in the hopes of finding an association between these loci and obesity, insulin secretion, insulin resistance and/or type 2 diabetes.

Effects of Sucralose on Drug Absorption and Metabolism (The SweetMeds Study)

Background: Artificial sweeteners like sucralose are found in many foods and drinks. Sucralose might affect hormones and cause health changes. Objective: To see if sucralose changes how medicines are absorbed and processed, how hormones are secreted, gut bacteria, and how fat cells are metabolized. Eligibility: People ages 18-60 who: * Are black or Hispanic * Weigh more than 110 pounds * Have a body mass index of 25-40 * Do not have a condition that requires drug treatment Design: Participants will be screened with: * Medical history * Physical exam * Blood, heart, and urine tests Participants must not eat or drink anything with artificial sweeteners throughout the study. Over 7 days, Participants will answer questions, and give daily urine samples and 1 stool sample. Participants will repeat these throughout the study. Overnight Visit 1: participants will fast starting the night before. They will get breakfast at the visit. The visit includes: * An IV will be placed in the arm. Participants will get 2 tablets of medicines. Blood will be drawn several times over 24 hours. * A piece of fat tissue may be taken from the abdomen (biopsy). * Participants will have a sweet drink. Blood samples will be taken over 2 hours. Then participants will be randomly assigned to take either a sucralose capsule or placebo. They will take it twice a day for 2 weeks. They will complete two 24-hour food diaries. Overnight Visit 2 repeats Visit 1 except the biopsy. Then participants will take the capsules for another 2 weeks. Overnight Visit 3 repeats Visit 1. Participants may be contacted by phone within 4 weeks after they finish.

Extension Trial to Evaluate the Long-term Efficacy, Safety, and Tolerability of Maridebart Cafraglutide (MARITIME-2-EXTENSION)

The primary objective of this trial is to evaluate the long-term efficacy, safety, and tolerability of maridebart cafraglutide in participants with obesity and type 2 diabetes mellitus. Trial 20210182 is extension of trial 20210184 (NCT06858878).

A Study of Orforglipron (LY3502970) in Chinese Participants With Obesity or Overweight and Weight-Related Health Problems

The purpose of this study is to learn how well orforglipron works and how safe it is in Chinese adults with obesity or overweight and related health problems. Participation in this study will last about 53 weeks (about 1 year).

Extension Trial to Evaluate the Long-term Efficacy, Safety, and Tolerability of Maridebart Cafraglutide (MARITIME-1-EXTENSION)

The primary objective of this trial is to evaluate the long-term efficacy, safety, and tolerability of maridebart cafraglutide in participants with obesity or overweight. Trial 20250197 is an extension of trial 20210181 (NCT06858839).

A Study to Investigate the Efficacy and Safety of Elecoglipron in Asian Participants With Obesity or Overweight With or Without Type 2 Diabetes Mellitus

The purpose of this study is to evaluate the efficacy and safety of elecoglipron compared with placebo adjunct to diet and exercise for weight management, in adult participants living with obesity or overweight with or without T2DM.

A Study on How NNC0174-1213 Works in People With Overweight or Obesity.

This study is testing a new study medicine to treat people living with overweight or obesity. The aim of this study is to see if the medicine is safe, how it works in human body, and what human body does to the study medicine. Participants will either get the new study medicine NNC0174-1213, a study medicine called "cagrilintide" or a placebo (a "dummy medicine" similar to the new study medicine and study medicine but without active ingredients). Which treatment participants will get is decided by chance. The new study medicine and the study medicine are potential new medicines which cannot be prescribed by doctors. This study will last for about a year in total.

AMAZE 9: A Research Study Investigating How Well Zenagamtide Tablets Help People With Excess Body Weight Lose Weight

The purpose of this clinical study is to find out if zenagamtide is safe and effective for treating people who have excess body weight. There are 2 study treatments in this study taken as oral tablets once a day. Participants will either get zenagamtide (the treatment being tested) or Placebo (treatment that has no active medicine in it). Which treatment participants get is decided by chance.

A Research Study Looking Into How UBT251 Works With Birth Control Tablets and Emptying of the Stomach in Women With Excess Body Weight Not Able to Become Pregnant

The purpose of this clinical study is to find out if UBT251 is safe and effective to be taken together with medicines, like birth control tablets, and emptying of the stomach in women not able to become pregnant living with overweight or obesity

A Research Study Investigating How Well the Medicine Zenagamtide Helps People With Excess Body Weight Lose Weight Compared to Semaglutide

The purpose of this study is to find out if zenagamtide is safe and effective for treating participants who have excess body weight compared to treatment with semaglutide.

A Research Study on How NNC0487-0111, a New Medicine, Works in Chinese Participants After 10 Days of Oral Dosing

The study is testing a new study medicine called NNC0487-0111 for weight control in Chinese people with Body mass index (BMI) greater than or equal to (\>=) 24 kilogram per square meter (kg/m\^2). The aim of this study is to find out how safe the study medicine is and how it behaves in your body. Participants will either get NNC0487-0111 or placebo. Which treatment participants will get is decided by chance. Oral NNC0487-0111 is a new medicine which cannot be prescribed by doctors but has previously been tested in humans. The study will last for about 60 days.

A Study of Orforglipron (LY3502970) in Adolescent Participants With Obesity, or Overweight With Related Comorbidities

The main purpose of this study, performed under Master Protocol J4M-MC-PWMP (NCT06672549), is to evaluate the efficacy, safety, and pharmacokinetics of orforglipron once daily oral versus Placebo in adolescent participants with obesity, or overweight with related comorbidities. Participation in the study will last about 18 months. Participants who have completed the primary PW01 study (including the 4-week safety follow-up period) will have the opportunity to receive an additional 156 weeks of treatment with orforglipron as well as continuing the lifestyle intervention.

A Study of LY3549492 in Healthy Participants and Participants With Overweight or Obesity

The purpose of this study is to see how safe and well-tolerated the drug LY3549492 is and how it behaves in the body, when given in multiple doses to healthy people who are overweight or have obesity. Participation in the study will last approximately 8 weeks.

AMAZE 13: A Research Study Investigating How Well the Medicine Zenagamtide Helps People in Asia With Excess Body Weight Lose Weight

The purpose of this clinical study is to find out if zenagamtide is safe and effective for treating people who have excess body weight. There are 2 study treatments in this study taken as injections under the skin once a week. Participants will either get zenagamtide (the treatment being tested) or placebo (a treatment that has no active medicine in it). Which treatment participants get is decided by chance.

A Study of Eloralintide (LY3841136) in Participants With Obstructive Sleep Apnea and Obesity or Overweight

The purpose of the studies is to evaluate the efficacy and safety of eloralintide in participants with moderate-to-severe obstructive sleep apnea and obesity or overweight. YDAO is a master protocol designed to support two independent studies: YSA1 and YSA2. Study YSA1 will include participants who are unable or unwilling to use Positive Airway Pressure (PAP) therapy and study YSA2 will include participants who are on PAP therapy for at least 3 months at time of screening and plan to continue PAP therapy during the study. Participants will be assigned to the Intervention-Specific Appendix (ISA) that reflects their current PAP usage. Participation in the study will last about 76 weeks.

A Platform Trial for Pediatric Participants With Obesity or Overweight (LY900040)

The purpose of this pediatric, chronic weight management, Phase 3 Master Protocol (PWMP) is to create a framework to evaluate the safety and efficacy of pharmacologic agents for the treatment of obesity or overweight in pediatric participants.

Piloting a Reinforcement Learning Tool for Individually Tailoring Just-in-time Adaptive Interventions

The purpose of this pilot study is to conduct a 12-week pilot feasibility study testing usability of a reinforcement learning model (AdaptRL) in a weight loss intervention (ADAPT study). Building upon a previous just-in-time adaptive intervention (JITAI), a reinforcement learning model will generate decision rules unique to each individual that are intended to improve the tailoring of brief intervention messages (e.g., what behavior to message about, what behavior change techniques to include), improve achievement of daily behavioral goals, and improve weight loss in a sample of 20 adults.

A Study of Retatrutide (LY3437943) in Participants Who Have Obesity or Overweight

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.

A Study of Eloralintide (LY3841136) in Participants With Obesity, or Overweight Without Type 2 Diabetes

The purpose of this study is to evaluate the efficacy and safety of eloralintide in adults with obesity or overweight who do not have type 2 diabetes. The study has two phases: a main phase and an extension phase. Participation in the main phase of the study will last about 75 weeks. Participants with prediabetes will continue in the extension phase for another 2 years.

A Study of Eloralintide (LY3841136) in Participants With Obesity or Overweight, and Type 2 Diabetes

The main purpose of this study is to evaluate the efficacy and safety of eloralintide compared with placebo for body weight reduction in participants with overweight or obesity and type 2 diabetes. Participation in the study will last about 75 weeks.

Efficacy and Safety of Petrelintide in Participants With Overweight or Obesity and Type 2 Diabetes (ZUPREME 2)

The main purpose of this study is to investigate efficacy and safety of three doses of petrelintide versus placebo in participants with overweight or obesity and type 2 diabetes.

A Study of Tirzepatide (LY3298176) in Adult Participants in India With Either Type 2 Diabetes Mellitus or Obesity

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.

A Study of Macupatide (LY3532226) and Eloralintide (LY3841136), Alone or in Combination, in Adults With Obesity or Overweight and With Type 2 Diabetes

The purpose of this study is to investigate weight reduction with macupatide and eloralintide, alone or in combination, in adult participants with obesity or overweight and with type 2 diabetes. Participation in the study will last about 48 weeks.