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HomeTrials › NCT06861439

Obesity & weight · Phase 4 · Active, not recruiting

GLP-1s to Enhance Lasting Optimal Weight

NCT06861439 · Sponsor: Wake Forest University Health Sciences

What this trial means for you

This study is active, not recruiting — it is not currently taking new participants, but its results may matter for treatments you're considering. It's studying Tirzepatide for obesity.

Who can joinAll sexes, 65 Years and older
Healthy volunteersNo — diagnosis required
What you'd takeTirzepatide
Study length~15 months overall
Planned participants40
TypeInterventional (you receive treatment)

What participants typically get: study medication (or placebo, if the trial uses one) and study-related medical care at no cost, plus close monitoring. Compensation for time and travel varies by study — ask the site. Note that in many trials you can't choose your treatment group, and some participants receive a placebo.

The study, in the sponsor's words

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.

Can you join? The exact criteria

Below is the verbatim eligibility text from the registry — bring it to your doctor; it's written for clinicians, and your own clinician is the right person to interpret it with you.

Full eligibility criteria (for you and your doctor)

Inclusion 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 Exclusion Criteria: * 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

Study sites by state

North Carolina

  • Wake Forest University Health Sciences — Winston-Salem

View the official record on ClinicalTrials.gov →

Verify before you act. Medical disclaimer: content on this site is for informational purposes only and is not medical advice. GLP-1 medications are prescription drugs; always consult a licensed healthcare provider about eligibility, risks, and benefits. Trial details and enrollment status change frequently — always verify on the official registry and talk to your own clinician before contacting a study site. This page was generated from registry data and is not affiliated with the study sponsor.

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