Clinical Research Directory

FutureShape Family

The number of adults and children living with obesity is increasing worldwide. Once childhood obesity has developed, more than 80% of children carry the obesity into adulthood, with a high risk of cardiometabolic disease, poor mental health, and decreased life expectancy. Parental obesity is a strong predictor of intergenerational obesity and is closely associated with a child's body composition from childhood through to adulthood. Obesity pharmacotherapy effectively reduces body weight. In adults, we have shown that combining obesity pharmacotherapy with supervised exercise improves weight-loss maintenance compared with pharmacotherapy alone. Emerging evidence suggest that exercise may also limit weight regain after treatment cessation. Together with evidence linking physical activity, sleep, and eating behaviours to weight regulation, these findings support combining pharmacological treatment with interventions targeting multiple modifiable behaviours. Personalised, data-driven feedback may further facilitate sustained behavioural change, but few interventions have integrated these approaches within the family setting. This 58-week randomized clinical trial aims to investigate the separate and combined effects of a data-driven, multimodal family-based intervention and semaglutide treatment for parents with obesity on body fat percentage and other health-related outcomes in parents and children. Approximately 400 families will be randomly assigned to one of four groups combining data-driven, multimodal family-based intervention or standard health advice with semaglutide or placebo. The data-driven, multimodal family-based intervention focuses on physical activity, diet, sleep and mental well-being. The trial will include families with at least one parent with obesity and at least one child aged 5 to 12 years with overweight or obesity. Participating parents with obesity will receive semaglutide or placebo once weekly for 28 weeks. The main outcomes are changes in body fat percentage in participating parents and children. Other outcomes include changes in body mass index (BMI) in parents and age- and sex-adjusted BMI, known as BMI z-score, in children. Families will participate in the main trial for 58 weeks and complete an additional follow-up assessment at week 104 after randomization.

Safety and Efficacy of ABBV-295 in Adults With Obesity or Overweight With Weight-Related Comorbidities

Obesity is a condition where a person has excessive body fat, defined by a body mass index (BMI) of 30 kg/m2 or higher. The goal of this study is to evaluate the effect of various doses of ABBV-295 compared to placebo on reducing body weight at Week 32 in participants with obesity or overweight with weight-related comorbidities. ABBV-295 is an investigational long-acting amylin analog being developed for chronic weight management. Participants are placed into multiple treatment groups with different dosing paradigms of ABBV-295 or placebo. Participants will not know which treatment they are receiving, and there is a chance of being assigned to placebo. Adults with obesity or overweight (as defined by BMI) with weight-related comorbidities will be enrolled. Approximately 360 participants will be enrolled in the study at approximately 70 sites in the United States and Puerto Rico. Participants will receive subcutaneous (SC) injections of ABBV-295 solution for injection or matching placebo administered via pre-filled syringes for 52 weeks during the Double-Blind Period. There may be higher treatment burden for participants in this trial compared to their standard of care due to study procedures. Participants will attend regular visits during the study at a hospital or clinic. The effects of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

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.

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. ...

A Study to Learn About the Study Medicine Called PF-08653944 in Otherwise Healthy Chinese Adults With Overweight or Obesity

The purpose of this study is to learn about: * How PF-08653944 is changed and removed from the body after taken * Safety of PF-08653944 * The extent to which side effects can be tolerated after taking PF- 08653944 for the possible treatment of heart failure This study is seeking participants who: * Are healthy Chinese adults who are aged 18 years and older * Have body mass index of 24 - 45 kilograms/meter2 * Have a total body weight of equal to or more than 50 kilograms (110 pounds) * Do not have prior significant medical conditions, history of drug or alcohol abuse All participants in this study will receive a single dose of PF-08653944 at the study clinic. The experiences of the participants receiving the study medicine will be looked at. This will help to see if the study medicine is safe. Participants will take part in this study for around 16 weeks. During this time, they will have 6 study visits at the study clinic.

Effect of Short-Term Beta-Cell Rest in Adolescents and Young Adults With Type 2 Diabetes Mellitus

This study will determine whether resting beta cells (cells in the pancreas that produce insulin) for 2 weeks will improve the ability of patients with Type 2 diabetes mellitus (T2DM) to make insulin. Beta cells can rest by giving patients insulin shots. The study will also examine how teenagers with T2DM feel about having diabetes and explore differences between young people with and without T2DM. This study includes patients 12 to 25 years of age with T2DM who are overweight and who were diagnosed within 2 years of enrolling in the study. Healthy individuals of normal weight or who are overweight are also eligible. Candidates are screened with a medical history, physical examination and laboratory tests. Participants with T2DM are assigned to one of two groups. Group 1 takes an anti-diabetes medicine called metformin and follows a diet prescribed by a study staff dietitian for 2 weeks. Group 2 takes metformin, follows the prescribed diet, and receives insulin through a pump under the skin for 2 weeks. During these two weeks, all participants have the following tests: * Frequent blood sugar checks. * Oral glucose tolerance test (routine diabetes test in which blood samples are drawn before and several times after the subject drinks a sugary solution). * Arginine stimulation to test the response of the body to arginine, a normal ingredient of food that stimulates the release of insulin. Two catheters are placed into veins in the arms, one to administer a liquid containing arginine, the other to draw the blood samples. * Ultrasound of the blood vessels in the neck to check for hardening of the arteries. * Metabolism test to measure the amount of oxygen used during rest. The subject breathes normally during rest while wearing a canopy over his or her head for about 20 minutes. * MRI scans of the abdomen to examine the amount of fat in the belly (at the beginning and end of the study) * DEXA scan to determine percent body fat. * Tests to explore quality of life and feelings about health, work or school, friends and family. * Exercise testing on a treadmill or stationary bicycle. * Genetic studies for information on diabetes and obesity. Normal volunteers have blood draws, oral glucose tolerance testing, MRI scan, DEXA scan, psychological testing, exercise testing, and genetic testing. ...

A Trial to Evaluate Interactions Between Antiemetic Medication and AMG 133 in Participants Living With Overweight or Obesity

The primary objective of this trial is to evaluate the pharmacokinetics (PK) of AMG 133 administered alone and in combination with an antiemetic medication, ondansetron, in participants living with overweight or obesity.

A Trial of Oral VRB-103 Alone or in Combination With Oral Ecnoglutide (VRB-101) in Participants With Obesity or Overweight

The primary objective is to evaluate the safety and tolerability of VRB-103 tablets administered as monotherapy or VRB-103 tablets administered in combination with oral ecnoglutide tablets (VRB-101 tablets) in a single-dose regimen or in a multiple dose regimen.

A Study to Test Whether BI 3034701 Helps People to Lose Weight Who Live With Obesity or Overweight

This study is open to adults between 18 and 74 years of age and who have a body mass index (BMI) of 30 kg/m2 or more, or a BMI of 27 kg/m2 or more and at least 1 health problem related to their weight. People who have previously not managed to lose weight by changing their diet can participate. People with type 2 diabetes cannot take part in this study. The purpose of this study is to find out whether a medicine called BI 3034701 helps people living with obesity or overweight to lose weight. This study has 7 groups of participants. Groups 1 to 6 get different doses of BI 3034701; Group 7 gets placebo. Placebo looks like BI 3034701 but does not contain any medicine. Every participant has more than an 80% chance of getting BI 3034701. Participants receive 2 injections of BI 3034701 or placebo under their skin for 42 weeks. In addition to the study medicine, all participants receive counselling to make changes to their diet and to exercise regularly. Participants are in the study for about 10 months. During this time, they visit the study site 15 times. The study doctors regularly measure the participants' body weight and take necessary laboratory tests. Participants also answer questions about their well-being and note their food intake and physical activity in diaries. The results will be compared between groups of participants to see whether the treatment works. The study doctors also regularly check participants' health and take note of any unwanted effects.

A Study of PF-08653945 and PF-08653944 in Adults With Overweight or Obesity

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 Weekly Oral Dose of Ecnoglutide (VRB-101) for Weight Maintenance in Participants Who Have Obesity or Overweight With Weight-Related Comorbidities

The purpose of this study is to identify the weekly oral dose of VRB-101 (oral ecnoglutide) that can effectively maintain body weight in participants with a history of obesity or overweight with weight-related comorbidities.

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).

A Study to Learn About the Study Medicine Called Berobenatide (PF-08653944) in People With Overweight or Obesity

The purpose of this clinical study is to learn about the effects and safety of berobenatide (PF-08653944). This may help people with overweight or obesity lose weight. People in this study may also have type 2 diabetes. About 950 adults will be in this study. Berobenatide will be compared to a placebo. A placebo does not have any medicine in it but looks just like the medicine being studied. Berobenatide or placebo is given by a shot under the skin in the belly area. The objective of the study is to compare the experiences of people receiving berobenatide to those of the people who do not to assess if the study medicine is effective and safe. People will take part in this study for about 20 months. During this time, they will have about 15 study visits at the site. They will also have 2 study visits over the phone.

A Study to Learn About the Study Medicine (PF-08653944) in People With Obesity or Overweight and Type 2 Diabetes (T2D)

The purpose of this clinical study is to learn about the safety and effects of the study medicine to help adults with obesity or overweight and type 2 diabetes lose weight. Being overweight or obese means carrying too much body weight. Type 2 diabetes is a condition where there is too much sugar in the blood. The study medicine is given by a shot under the skin in the belly area. The participants will be trained to do this at home once every week. About 660 out of 1000 adults will also receive the study medicine and about 330 out of 1000 adults will receive placebo. A placebo does not have any medicine in it but looks just like the medicine being studied. The investigators will compare the experiences of people receiving the study medicine to those of the people who do not. This will help us assess if the study medicine is safe and effective. People will take part in this study for about 21 months. During this time, they will have about 14 study visits at the site and 5 over the phone.

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.

A Research Study Investigating How Adults With Overweight or Obesity, With or Without Type 2 Diabetes, Tolerate Switching to a New Treatment (Zenagamtide) From Their Current Tirzepatide Medication

The purpose of this clinical study is to find out which zenagamtide dose can be switched to, from maintenance dose of tirzepatide in people with overweight or obesity, with or without type 2 diabetes (T2D). All participants will get tirzepatide and zenagamtide.

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 Study to Investigate Weight Management With Macupatide and Eloralintide, Alone or in Combination, in Adult Participants With Obesity or Overweight

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.

A Study to Evaluate the Effects of Enicepatide in Participants With Obesity or Overweight, With or Without Type 2 Diabetes

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) being developed for chronic weight management, as an adjunct to a reduced-calorie diet and increased physical activity in participants without Type 2 diabetes mellitus (T2DM) who have obesity or overweight with at least one weight-related comorbidity, and in participants with T2DM who have obesity or overweight.

A Study of Eloralintide (LY3841136) in Female Participants With Obesity or Overweight

The main purpose of this study is to evaluate how eloralintide (LY3841136) effects the way the body processes oral contraceptive in female participants with obesity or overweight. For each participant, the study will last about 8 months and will include 3 stays in the Clinical Research Unit (CRU), each lasting between 6 - 8 nights.

Evaluating the Impact of Maridebart Cafraglutide on Cardiovascular Outcomes in Participants With Atherosclerotic Cardiovascular Disease and Overweight or Obesity

The primary objective of this trial is to demonstrate that maridebart cafraglutide is superior to placebo when given as an adjunct to standard of care with respect to reducing cardiovascular (CV) morbidity and mortality.

A Study of Orforglipron in Participants With Overweight at Risk of Development of Obesity-Related Complications or Progression to Class 1 Obesity

This study will evaluate the efficacy and safety of orforglipron in participants with overweight and assess whether it helps reduce the future risk of obesity-related conditions, including type 2 diabetes, hypertension, and dyslipidemia, and progression to class 1 obesity.

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.

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.