RECRUITING

GLP-1s to Enhance Lasting Optimal Weight

Conditions

Obesity Weight Loss Muscle Loss Physical Disability Bone Density Older Adults

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The goal of this study is to examine how tirzepatide affects body composition, bone health, and physical performance in older adults over a nine-month period. Participants will take tirzepatide weekly, have clinic visits every 4 weeks, meet study doctor and registered dietitian every 4 weeks in person or video conference, attend group intervention sessions twice a month via video conference, weigh daily with a study-provided smart scale, keep a record of all foods and beverages consumed, and use a study-provided activity tracker to keep track of daily step counts.

Official Title

Effects of Tirzepatide on Fat-Free Mass, Bone and Physical Function in Older Adults - a Pilot Study

Quick Facts

Study Start:2025-07

Study Completion:2026-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06861439

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* BMI 30-37 kg/m2 or BMI 27-\<30 kg/m2 with at least 1 weight-related comorbidity * community dwelling * able to provide own transportation to study visits * willing to provide informed consent * willing to take terzepatide for 9 months * agree to all study procedures/assessments * approved for participation by the study physician	* dependent on a cane or walker or needing assistance with any activity of daily living * history of mild cognitive impairment or dementia or cognitive impairment on Montreal Cognitive Assessment (MoCA score \<22) * evidence of depressive symptoms (Center for Epidemiologic Studies Depression scale score =\>16 * use of \>1 tobacco product/day or 4/week or vaped \>1/week in past year * excessive alcohol use in past month (\>7 drinks/week for women; \>14 drinks/week for men) * weight loss or gain \>5% in past 3 months * vegan or other severe dietary restriction * history of binge eating disorder * regular participation in high intensity aerobic or resistance exercise training \>150 mins/week * severe arthritis, fracture, chronic injury, or other musculoskeletal disorder that prevents walking independently * joint replacement or other orthopedic surgery in past 6 months or planned in next 12 months * osteoporosis (self report or DXA t-score \<= -2.5 on total hip and/or femoral neck) * uncontrolled hypertension (systolic \>160 OR diastolic \>100 mmHg) upon repeated assessments * type 1 diabetes * uncontrolled type 2 diabetes (HbA1c \>7.5%), type 2 diabetes diagnosed within last year, or newly identified type 2 diabetes (HbA1c \>6.5%) * dialysis or abnormal kidney function (eGFR \<30 ml/min/1.73m2) * liver disease or abnormal liver function (ALT levels 2 times above normal limit) * severe anemia (Hb \<11 g/dL) * potassium or sodium above or below normal limits * uncontrolled thyroid disease (hypo/hyper) or requiring recent (past 3 months) adjustments in thyroid hormone supplementation or TSH \<0.45 or \>4.5 mU/L * stroke, heart attack, heart failure hospitalization, or revascularization procedure within the past year; New York heart failure Class \>2; COPD requiring oxygen use; uncontrolled angina; PAD diagnosis within the last year; progressive neurologic disease (e.g., Parkinson's, ALS, MS); other diseases suggesting a life-expectancy \<3 years * personal or family history of medullary thyroid carcinoma, history of multiple endocrine neoplasia syndrome type 2, or any other cancer (except non-melanoma skin cancers) requiring treatment in past year * history of gastroparesis or pancreatitis * cholelithiasis, severe irritable bowel syndrome or Crohn's disease * history of stomach or small intestinal surgery (except appendectomy but including surgery for weight loss) * recent (within 4 weeks) acute respiratory illness including influenza, COVID-19 * overnight hospitalization within the past 6 months * regular use of growth hormones, medications prescribed for weight management, prescription osteoporosis medications, certain prescription medications for diabetes including insulin, sulfonylurea, meglitinides, GLP-1 agonists, SGLT2 inhibitors * use of oral steroids for \>1 month within the last 3 months * current participation in another intervention research study * planned out of town trips greater than 3 weeks in the next year

Inclusion Criteria

Exclusion Criteria

* BMI 30-37 kg/m2 or BMI 27-\<30 kg/m2 with at least 1 weight-related comorbidity
* community dwelling
* able to provide own transportation to study visits
* willing to provide informed consent
* willing to take terzepatide for 9 months
* agree to all study procedures/assessments
* approved for participation by the study physician

* dependent on a cane or walker or needing assistance with any activity of daily living
* history of mild cognitive impairment or dementia or cognitive impairment on Montreal Cognitive Assessment (MoCA score \<22)
* evidence of depressive symptoms (Center for Epidemiologic Studies Depression scale score =\>16
* use of \>1 tobacco product/day or 4/week or vaped \>1/week in past year
* excessive alcohol use in past month (\>7 drinks/week for women; \>14 drinks/week for men)
* weight loss or gain \>5% in past 3 months
* vegan or other severe dietary restriction
* history of binge eating disorder
* regular participation in high intensity aerobic or resistance exercise training \>150 mins/week
* severe arthritis, fracture, chronic injury, or other musculoskeletal disorder that prevents walking independently
* joint replacement or other orthopedic surgery in past 6 months or planned in next 12 months
* osteoporosis (self report or DXA t-score \<= -2.5 on total hip and/or femoral neck)
* uncontrolled hypertension (systolic \>160 OR diastolic \>100 mmHg) upon repeated assessments
* type 1 diabetes
* uncontrolled type 2 diabetes (HbA1c \>7.5%), type 2 diabetes diagnosed within last year, or newly identified type 2 diabetes (HbA1c \>6.5%)
* dialysis or abnormal kidney function (eGFR \<30 ml/min/1.73m2)
* liver disease or abnormal liver function (ALT levels 2 times above normal limit)
* severe anemia (Hb \<11 g/dL)
* potassium or sodium above or below normal limits
* uncontrolled thyroid disease (hypo/hyper) or requiring recent (past 3 months) adjustments in thyroid hormone supplementation or TSH \<0.45 or \>4.5 mU/L
* stroke, heart attack, heart failure hospitalization, or revascularization procedure within the past year; New York heart failure Class \>2; COPD requiring oxygen use; uncontrolled angina; PAD diagnosis within the last year; progressive neurologic disease (e.g., Parkinson's, ALS, MS); other diseases suggesting a life-expectancy \<3 years
* personal or family history of medullary thyroid carcinoma, history of multiple endocrine neoplasia syndrome type 2, or any other cancer (except non-melanoma skin cancers) requiring treatment in past year
* history of gastroparesis or pancreatitis
* cholelithiasis, severe irritable bowel syndrome or Crohn's disease
* history of stomach or small intestinal surgery (except appendectomy but including surgery for weight loss)
* recent (within 4 weeks) acute respiratory illness including influenza, COVID-19
* overnight hospitalization within the past 6 months
* regular use of growth hormones, medications prescribed for weight management, prescription osteoporosis medications, certain prescription medications for diabetes including insulin, sulfonylurea, meglitinides, GLP-1 agonists, SGLT2 inhibitors
* use of oral steroids for \>1 month within the last 3 months
* current participation in another intervention research study
* planned out of town trips greater than 3 weeks in the next year

Contacts and Locations

Study Contact

Charlotte Crotts, CCBDT

CONTACT

336-713-8503

chcrotts@wakehealth.edu

Principal Investigator

Denise Houston, PhD

PRINCIPAL_INVESTIGATOR

Atrium Health Wake Forest Baptist

Study Locations (Sites)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157

United States

Collaborators and Investigators

Sponsor: Wake Forest University Health Sciences

Denise Houston, PhD, PRINCIPAL_INVESTIGATOR, Atrium Health Wake Forest Baptist

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-07

Study Completion Date2026-12-31

Study Record Updates

Study Start Date2025-07

Study Completion Date2026-12-31

Terms related to this study

Keywords Provided by Researchers

Weight Loss
Muscle Loss
Physical Disability
Bone Density
Older Adults

Additional Relevant MeSH Terms

Obesity