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38 recruiting in MN
Recruiting

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

Atherosclerotic Cardiovascular Disease · Overweight · 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.

Maplewood, Minneapolis, MN45–99 yrsAll genders
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A Study of Eloralintide (LY3841136) in Participants With Obstructive Sleep Apnea and Obesity or Overweight

Sleep Apnea, Obstructive · Obesity · 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.

Maplewood, MN18+ yrsAll genders
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A Study of CX11 Tablets in Patients With Type 2 Diabetes Mellitus

Type II Diabetes Mellitus

This study is testing whether a new medication called CX11 works and is safe for participants with type 2 diabetes who have not reached good blood sugar control while taking a steady dose of metformin, with or without a steady dose of an SGLT2 inhibitor, for at least 90 days. The study is being done at multiple medical centers. Participants are assigned by chance (randomized) to different groups, and neither the participants nor the study staff know which group they're in (double-blind). The groups are compared side by side (parallel), and some participants will receive inactive pills (placebo) to help measure the true effect of the study drug. After screening, participants will be randomly placed into one of six groups, with equal chances of being in any group. Each group will receive a different dose of CX11 or a placebo. Treatment will last 24 weeks. After that, all participants will have a 2-week follow-up period to check on safety.

Edina, Mankato, MN18–75 yrsAll genders
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Individualized Pharmacological Approach to Obesity in Patients With Bipolar Disorder

Bipolar I Disorder · Bipolar II Disorder · Schizo Affective Disorder

The goal of this clinical trial is to identify the specific characteristics (phenotypes) that may be useful to help select the right medication for weight loss, and to study the effect of individualized guided medication in patients with bipolar disorder ages 18-65. The main questions it aims to answer are: * Can the investigators compare the distribution of obesity characteristics (hungry brain, hungry gut, emotional hunger) between bipolar patients and non-bipolar participants (comparing from IRB #24-002375)? * Can the investigators evaluate the feasibility of anti-obesity medication (AOM) in patients with bipolar disorder? Participation will last for about 20 weeks and includes 8 in-person study visits, up to 11 phone call visits, and 13 virtual group therapy sessions. The first visit lasts about 2 hours and includes going over the informed consent form, a diagnostic interview to confirm diagnosis, gathering vital signs, mood questionnaires, an ECG, a blood draw, and urine drug and pregnancy tests (if applicable). The second visit lasts about 6-7 hours and involves multiple procedures and completing questionnaires to determine which study drug would allow participants to lose weight most effectively. At the third visit, participants will be assigned to take one of three FDA approved medications for weight loss: Semaglutide (Wegovy®), Naltrexone/Bupropion (Contrave®), or Phentermine/Topiramate (Qsymia®). It is possible that participants could be assigned to a group that receives no study medication. All participants will be enrolled in a 12-week virtual group therapy program targeted for weight loss. On this third visit the investigators will also gather vital signs, and participants will give a sample of blood. After the third visit, participants will come in for study visits every 4 weeks for 20 weeks (5 visits) to assess medication adherence, vitals, and answer questions about mood and eating (participants will also give a sample of blood at the 8-week and 20-week visits). For participants assigned to a study medication, the study team will call every week for the first 2 months (excluding in-person visit weeks) to assess mood and safety. After the first 2 months, the study team will call the participant every two weeks in between in-person visits. Participants will be compensated for time spent in this study. Participants assigned to a study medication will also be given the option to participate in the open-label phase of the study, which involves 3 follow-up visits (weeks 24, 36, and 48) over 7 months after the 20-week trial. During this phase, participants can continue to take the medication through their clinical care provider.

Rochester, MN18–65 yrsAll genders
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Recruiting

Project SHINE (Sleep Health INitiative for Equity): Culturally Informing a Sleep Extension Intervention for African American Adults

Obesity · Insufficient Sleep

The proposed research aims to reduce obesity-related health disparities by promoting healthy lifestyle behaviors among African Americans (AAs), given the high disease burdens associated with low physical activity, insufficient sleep, and obesity. There will be two phases to the proposed research. Phase 1 (Aim 1) will encompass formative research and community engagement activities, and Phase 2 (Aim 2a and 2b) will be a randomized clinical trial. The primary goal of Aim 1 is to conduct in-depth qualitative interviews in order to: (1) better understand sleep-related social contextual factors, knowledge, behaviors, and beliefs, and (2) discuss and receive feedback on an existing sleep intervention design and materials. The primary goal of Aim 2 is to explore the feasibility, satisfaction, and preliminary efficacy of a sleep intervention to increase sleep and physical activity (PA) among sedentary and short sleeping (≤6 hrs/night) African American adults with overweight/obesity, compared to a contact control group. (Aim 2a) An additional exploratory (Aim 2b) examines changes in cancer-relevant biomarkers between those who received the intervention vs the control condition (n = 20). Data will be collected from a sample of 20 participants (10 per condition) who volunteer to have their blood drawn pre- and post-intervention. There are two phases of the study, and information gained during Phase 1 (Aim 1) will be used to inform Phase 2 (Aim 2). Thus, additional modifications to the protocol will be submitted prior to engagement in Phase 2.

Minneapolis, MN21–75 yrsAll genders
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A Study of Aleniglipron in Adults With Obesity or Overweight and Type 2 Diabetes Mellitus (ACCOMPLISH-2)

Obesity · Overweight · Chronic Weight Management

This is randomized, double-blind, placebo-controlled study of the long-term efficacy, safety, and tolerability of multiple doses of aleniglipron in participants living with overweight or obesity and T2DM. Participants will be randomized to aleniglipron or placebo for a total of 76 weeks of treatment.

Mankato, Minneapolis, MN18–79 yrsAll genders
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Recruiting

Self-Weighing for Adolescents Seeking Obesity Treatment

Adolescent Obesity

99 patients age 12 to \<18 years old with obesity (BMI \>/=95th percentile), will be randomized to one of three treatment interventions: 1. Usual Care 2. Usual Care plus advice to weigh daily on simple scale 3. Usual Care plus advice to weigh-daily on an EHR-connected scale Survey data collected at baseline, 2, 4, 6, and 12-weeks, and qualitative interviews at 12 weeks, will assess acceptability, safety, self-efficacy, and BMI. Recruitment will also be assessed (% eligible patients who consent). In order to understand real-world feasibility of this intervention, the clinic staff will work with patients to connect the scales to Epic.

Minneapolis, MN12–17 yrsAll genders
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Recruiting

Upper Body Subcutaneous Exosome Release in Response to a Meal in Obesity

Obesity

The purpose of this study is to understand the specific outflow and difference between normal weight and volunteers with obesity of upper body subcutaneous adipose tissue in response to a mixed meal challenge by site specific cannulation of the superior epigastric vein. We will characterize the exosome signatures in response to a meal and compare to the exosome signature of arterialized venous plasma samples.

Rochester, MN18–55 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.

Mankato, Maplewood +more, MN18–99 yrsAll genders
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Functional Improvement in OSA and COPD With a Telehealth LifeStyle and Exercise Intervention

Chronic Obstructive Pulmonary Disease · Obstructive Sleep Apnea · Overweight and Obesity

The investigators will conduct a Type I hybrid effectiveness-implementation study to test an integrated telehealth intervention among 400 overweight and obese patients with Chronic Obstructive Pulmonary Disease (COPD) and Obstructive Sleep Apnea (OSA). The investigators will include eligible participants receiving primary care at one of five Department of Veterans Affairs (VA) medical centers and their community-based outpatient clinics. The investigators will randomize patients in a 1:1 ratio to the multi-component intervention or "enhanced" usual care, stratifying by age (≥65 vs. \< 65) and site. Participants randomized to the intervention will receive an integrated, telehealth-delivered intervention composed of a self-directed lifestyle program and supervised pulmonary rehabilitation. At the end of 3 months, the investigators will offer to enter a recommendation for weight management medications on behalf of eligible intervention participants. In the post-core period (months 4-12), participants will continue to have as-needed access to the lifestyle coach. For participants randomized to the "enhanced" usual care group, study staff will prompt the patient's primary care provider to refer them to existing weight loss management and pulmonary rehabilitation programs. Follow-up will occur at virtual visits at 3 and 12 months. The primary effectiveness outcome at 1-year is quality of life measured by the SF-12 Physical Component Summary Score. Secondary effectiveness outcomes will include other measures of quality of life (including sleep related impairment), sleep disturbance, disease severity (COPD exacerbations and respiratory event index for OSA), depression, social support, weight loss and cardiovascular risk. In addition to assessing effectiveness, investigators will also conduct a concurrent implementation process evaluation using the RE-AIM framework.

Minneapolis, MN18+ yrsAll genders
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Recruiting

AMAZE 2: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight and Type 2 Diabetes Lose Weight

Diabetes Mellitus · Overweight · Obesity

The purpose of this clinical study is to find out if NNC0487-0111 is safe and effective for treating people who have excess body weight and type 2 diabetes. 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 (treatment that has no active medicine in it). Which treatment participants get is decided by chance.

Minneapolis, MN18+ yrsAll genders
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