Clinical Research Directory

A Master Protocol Study of Orforglipron (LY3502970) in Participants With Hypertension and Obesity or Overweight (ATTAIN-Hypertension) GZL1

GZL1 is an independent study conducted under the GZPL master protocol. GZL1 will evaluate the efficacy and safety of orforglipron for treatment of hypertension in participants with obesity or overweight.

A Phase 2b Study to Examine the Safety and Efficacy of Once-Weekly MET097 in Adults With Obesity or Overweight

This study is designed to test how well MET097, an active drug, works to treat individuals with obesity or overweight when compared to placebo. MET097 or placebo will be given to individuals weekly for 28 weeks. If an individual is assigned to MET097 they will receive one of four different dose levels. Participants who have completed the first 28 weeks may participate in an exploratory extension study.

A Phase 2b Study to Evaluate the Efficacy and Safety of Once-Monthly MET097 in Adults With Obesity or Overweight

This study is designed to test the weight loss effects, safety, and tolerability of multiple monthly doses of MET097 after 12 weekly doses, compared to placebo. Participants are eligible if they have overweight or obesity and do not have type 2 diabetes.

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

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.

Remotely Delivered Resistance Training for Cardiometabolic Health Among Black Women

The purpose of this study is to collect preliminary data on the feasibility, acceptability, and potential effects of a novel, remotely delivered resistance training program.

Acute Impact of Whey Protein-enriched Milk Fat Globule Membrane Supplementation on Postprandial Markers of Heart and Brain Health

In a single-blind, randomised, placebo-controlled crossover manner, this study aims to assess the impact of a high-fat mixed meal containing a whey protein (WP)-enriched milk fat globule membrane (MFGM) powdered ingredient on markers of heart and brain health in the fed state among middle-to-older-aged, postmenopausal women living with overweight and at moderate risk for cardiovascular disease. Participants will attend two \~8 hour study visits, where they will consume a high-fat meal containing a WP-enriched MFGM powdered ingredient or a placebo WP-based powdered ingredient. Each visit will involve anthropometric measurements and periodic assessments of heart health, including blood pressure and blood vessel stiffness measurements, blood sample collections, as well as computer-based tests measuring mood and cognition (brain function) over a 6-hour postprandial period.

Safety and Drug Concentrations of REGN20934 in Adults With Overweight or Obesity

This study will test a study drug called REGN20934 to see how safe and well tolerated this drug is, as well as how the drug is processed in the body for participants with overweight or obesity. The study is looking at: * What side effects REGN20934 might cause * How much REGN20934 is in the blood at different times * If the body makes antibodies to REGN20934

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)

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.

Functional Fitness for Overweight or Obese Adults With Mobility Disabilities

Over 64 million people in the U.S. have a permanent disability, with mobility-related disability (MRD) representing the most prevalent disability type (13.7%). Adults with MRD are 66% more likely to be overweight or obese than their non-disabled peers. Exercise in adults with MRD is important for weight management and is associated with improvements in obesity-related health conditions including hypertension, hyperlipidemia, insulin processing/sensitivity, etc. However, over half (57%) of adults with MRD do not exercise, while 22% engage in exercise of insufficient duration or intensity to obtain health benefits. Adults with MRD face numerous barriers to participation in community-based exercise, and exercise is frequently limited to short-term referrals for outpatient physical and/or occupational therapy. High-intensity functional training (HIFT) represents a potentially effective strategy for community-based exercise to support body weight and obesity-related health conditions, in addition to improving physical function and aspects of psychosocial health for people with disabilities. Preliminary evidence supports the effectiveness of HIFT to improve body composition, cardiovascular and muscular fitness, insulin processing and insulin sensitivity in non-disabled adults who are overweight/obese. To date, no study has systematically evaluated the feasibility or effectiveness of a community-based HIFT intervention for improving obesity-related health outcomes in overweight/obese adults with MRD. Thus, the proposed study will implement a 6-mo. pilot trial to evaluate the feasibility and potential effectiveness of a HIFT intervention (60 min sessions/3 days/wk.) in 25 adults with MRD and overweight/obesity. This study will address the following aims: Aim 1: Evaluate the intervention feasibility based on participant recruitment, session attendance, retention, outcome assessment completion, and the results of semi-structured exit interviews to obtain information regarding experience and overall satisfaction with the intervention. Aim 2: Evaluate changes (baseline - 6 mos.) in weight and fat-mass/fat-free mass, and components of the metabolic syndrome (waist circumference, blood pressure, HDL-cholesterol, triglycerides, fasting glucose).

Effect of Low-calorie Diets With Different Macronutrient Composition and Macronutrient Distribution in Shift Workers With Prediabetes or Type 2 Diabetes and Overweight or Obesity.

Background and Aims: Shift work, particularly involving night shifts, is associated with increased risk of metabolic disturbances such as type 2 diabetes mellitus (T2DM). Thus, it is important to explore mechanisms underlying this deleteroius effect and strategies that could prevent or mitigate it. The aim of the study is to investigate the effect of three low-calorie diets with different macronutrients composition and distribution along day on glucose metabolism and other health outcomes in overweight or obese shift workers with prediabetes or T2DM. Methods: In this randomized controlled trial, 120 shift workers with a BMI \> 27.5 kg/m2 and diagnosed with prediabetes or T2DM will be recruited. The trial assesses three low-calorie diets effects on glucose metabolism, body composition, and health outcomes over 12 weeks. These diets include: A) high-protein dinner (60% of total daily protein), B) low-protein dinner (15% of total daily protein), and C) normoproteic diet.

A Study of PF-08653945 and PF-08653944 in Adults With Overweight or Obesity (SOLIS-1)

This study is being done to learn about the safety and effects of the study drugs, PF-08653945 and PF-08653944, when given alone or together for weight loss, compared to a placebo (a dummy drug that has no active ingredient in it).

A Study of Multiple Doses of Orally Administered RO7795081 in Otherwise Healthy Chinese Adult Participants With Obesity or Overweight

This is an investigator- and participant-blind, randomized, placebo-controlled, parallel-group, Phase I study evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple doses of orally administered RO7795081 in otherwise healthy Chinese adult participants with obesity or overweight.

Promote Weight Loss in Obese Peripheral Artery Disease (PAD) Patients to Prevent Mobility Loss

The PROVE Trial is a randomized clinical trial that will determine whether a weight loss intervention combined with walking exercise achieves greater improvement or less decline in six-minute walk distance at 12 month follow-up than walking exercise alone in people with PAD and BMI\>25 kg/m2. The intervention uses a Group Mediated Cognitive Behavioral framework, connective mobile technology, remote monitoring by a coach, and a calorie restricted Dietary Approaches to Stop Hypertension (DASH)-derived Optimal Macronutrient Intake Trial for Heart Health (OMNIHeart) diet. 212 participants with PAD and BMI \> 25 kg/m2 will be randomized to one of two groups: weight loss + exercise (WL+EX) vs. exercise alone (EX). Participants will be randomized at Northwestern, Tulane University, and University of Minnesota. Our primary outcome is change in six-minute walk distance at 12-month follow-up. Secondary outcomes are change in 6-minute walk distance at 6-month follow-up and change in exercise adherence, physical activity, patient-reported walking ability (measured by the Walking Impairment Questionnaire (WIQ) distance score), and mobility (measured by the Patient-Reported Outcomes Measurement Information System \[PROMIS\] mobility questionnaire) at 12-month follow-up. Tertiary outcomes are perceived exertional effort (measured by the Borg scale at the end of the 6-minute walk at 12-month follow-up), and diet quality. Exploratory outcomes consist of change in the short physical performance battery (SPPB), the WIQ stair climbing and walking speed scores, and calf muscle biopsy measures at 12-month follow-up. Study investigators will perform calf muscle biopsies in 50 participants to compare changes in mitochondrial biogenesis and activity, capillary density, and inflammation between WL+EX vs. EX.

Development of PI-ML Algorithm for Prediction of the Real-time Risk for Developing Pre-diabetes

In this prospective, non-randomized, monocentric study, data will be collected from otherwise healthy individuals with overweight/obese grade I to increase data availability in the pre-diabetes field (impaired glucose intolerance), and to validate the outputs of an algorithm for the "physics-informed machine learning (PIML)" designed to estimate the real-time risk of prediabetes. Each participant will take part in the study for 4 months, including 3 onsite visits. During the screening visit, participants' eligibility will be determined by checking the inclusion and exclusion criteria after detailed information and obtaining informed consent by the investigator. Blood will be withdrawn for exclusion of existing prediabetes/diabetes at the fasted state. For women in reproductive age, a urinary pregnancy test will be performed. After getting the results of blood tests (glucose and HbA1c), participants will be asked to participate in study. On the visit 1, eligible participants will arrive at the study centre in a fasting state. Blood samples will be collected and participants will get vials and instructions for collection of stool and urine samples. Anthropometric data, lifestyle habit (cigarette, alcohol consumption) and family history will be collected. A 6-minute walking test to determine VO2 max will then be performed. Lap counts and time will be manually recorded using a sports watch. The Polar H10 heart rate monitor chest strap will be used to record heart rate (HR) throughout the test. To measure resting HR and heart rate recovery (HRR), participants will be asked to sit still for 5 minutes before the walking test and for 2 minutes after the test. Participants will receive a blinded Abbott Libre Pro glucose sensor, which they will wear for the next 14-days. Further, participants will be provided with a Fitbit Charge 5 health and fitness wristband. For validation purposes some part of study participants will be kindly asked to test newly develop wrist-worn device (EDIBit). With the help of 24-hour food recall, study subjects will be trained by medical staff on how to correctly enter their food intake in the Study app for completion of digital 3-day food diaries. They will be asked to fill in the diaries for 3 days after study visit1 and 3 days before study visit2. They will also receive a food frequency questionnaire during visit1. The second study visit will run nearly identical to study visit1 (except for food frequency questionnaire which will be omitted). During this visit, participants will receive information sheets on physical activity and dietary recommendations. The third and last visit will run nearly identically to the study visit2, except that no new glucose sensor will be inserted and also stool samples will not be collected.

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HRS-4729 Injection in Healthy Subjects

The study is being conducted to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of HRS-4729 injection in healthy subjects.

Study of Olatorepatide in Adult Participants Living With Overweight or Obesity in the US

This study will test olatorepatide (study drug) to determine how safe and effective this drug is and how easily your body can accept this drug without causing side effects, as well as how the drug is processed in the body by participants with overweight or obesity. The study will test how safe and effective the study drug works compared to placebo in people who are overweight or obese but do not have diabetes. The study is looking at: * What side effects the study drug might cause * How much the study drug is in the blood at different times * How well the study drug works * If the body makes antibodies to the study drug as this may cause the study drug to not work as well

PA Moves Trial - Patient Participants

The purpose of this study is to address physical inactivity in rural populations in Pennsylvania.

Effect of an Early Time Restricted Eating Mediterranean Diet Compared to Naltrexone/Bupropion on Liver Fibrosis in People With Cardiometabolic Risk Factors in a Hospital Outpatient Clinic (MEDFAST-study)

In the Netherlands, there are many people with cardiometabolic diseases. More than half of these people also have fatty liver. This is a build-up of fat in the liver (steatosis) and can lead to long-term scarring (fibrosis) and even death of the liver. Losing weight can help reduce this. Losing weight can be done with medication such as naltrexone/bupropion, which is often prescribed to people with cardiometabolic diseases, but losing weight can also be done with diet. In this study, the investigators want to combine a Mediterranean diet (with lots of vegetables, fruits, whole grain products, nuts and olive oil) with intermittent fasting. In addition participants are not allowed to eat after the evening meal. The investigators will compare this with a group of participants receiving naltrexone/bupropion, to see if a diet with intermittent fasting might be better for reducing liver steatosis and fibrosis in people with cardiometabolic diseases.

A Study of LY4064912 in Healthy Participants and With Overweight or Obesity

The purpose of this study is to evaluate how well LY4064912 is tolerated and what side effects may occur in healthy participants and participants with overweight and obesity - global. The study drug will be administered either subcutaneously (SC) (under the skin) or infusion intravenously (IV) (into a vein in the arm). Blood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body.

A Study of Daily Oral Orforglipron (LY3502970) Compared With Insulin Glargine in Participants With Type 2 Diabetes and Obesity or Overweight at Increased Cardiovascular Risk

The main purpose of this study is to determine safety and efficacy of orforglipron compared with insulin glargine in participants with type 2 diabetes and obesity or overweight at increased cardiovascular risk. The study will last approximately 2 years may include up to 27 visits.

The Safety, Tolerability, and Pharmacokinetics of of SYH9017 in Chinese Participants With Overweight and Obesity

This is a randomized, double-blind, single-center, dose-escalation, single ascending dose and multiple ascending dose study of SYH9017 in Chinese participants with overweight and obesity.

Effect of the Thrive AI Health App on Lifestyle Behaviors and Quality of Life

The goals of this randomized trial is to learn: 1. If the Thrive AI Health app will help adults improve their everyday habits (diet, exercise, and sleep). 2. How often participants will use the Thrive AI Health app to which they will have free access The Thrive AI Health app uses artificial intelligence (AI) to give personalized advice. It is designed to help people eat better, exercise more, manage stress, and sleep well. Researchers will compare changes in diet, exercise and sleep in participants using the app to those participants not using the app. Participants will complete study questionnaires and an in-person visit at the beginning and end of the study.

Berries, Inflammation, and Gut Microbiome

The primary objectives are to characterize changes in indices of systemic and gut inflammation, assess host- and microbial-derived metabolite pools, and describe and link functional metagenomics and metatranscriptomic alterations in the gut microbiome with metabolite and inflammatory outcomes after acute (24hr) and chronic (4 week) intake of anthocyanins and ellagitannins from strawberry and red raspberries compared to a control diet (negative control), FOS (positive control, non-polyphenol, carbohydrate-based fermentable fiber/pre-biotic), or combination diet (berry composite + FOS) in human participants with low-grade inflammation.

Extension Study of the Phase 3 Clinical Study of GZR18 Injection for Weight Loss

This is a Phase 3 extension study conducted in subjects who have received GZR18 Injection once every 2 weeks (Q2W) for weight loss treatment for 52 weeks, aiming to explore the effect and safety of continuous injection of GZR18 Injection once every 4 weeks (Q4W) for 24 weeks on body weight. In this study, it is planned to include subjects who have participated in the original study and completed the study contents of the original protocol. All subjects will maintain a regular diet and exercise lifestyle during the study.