Tirzepatide to Slow Biological Aging

NCT07220473 | Recruiting Phase 2 FDA Drug

• 1 other identifier: 25-0169
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

This pilot clinical study aims to investigate the potential effects of tirzepatide on biological aging in older adults. In this novel study, 90 adults aged 55-70 years with an indication for tirzepatide weight-loss therapy will be randomized to receive either tirzepatide 2.5 mg subcutaneously (SC) weekly or no drug for 24 weeks, followed by 12 weeks off the drug. Since tirzepatide is already recognized as a highly effective weight-loss agent in this population, the primary focus will not be on measuring weight loss. Instead, the study will document the effects of tirzepatide on markers of aging, physical function, and overall health.

Conditions

Aging; LONGEVITY 1

Keywords

DNA Methylation; Biological Clock Deceleration; GLP-1 Agonist

Outcome Measures

Primary Outcomes (1)

• Change in DNA Methylation-Based Biological Age

  Change in biological age as measured by DNA methylation-based aging clocks (DNAmAge, DNAm PhenoAge, DNAm GrimAge, and DunedinPACE) following tirzepatide treatment.

  Immediately before and after the study visit at Weeks 4, 12, and 24

Study Arms (2)

Tirzepatide

ACTIVE COMPARATOR

Participants will receive Tirzepatide 2.5 mg weekly for 24 weeks, followed by a 12-week off-drug follow-up.

Drug: Zepbound

Placebo

NO INTERVENTION

Participants will be monitored for a total of 36 weeks without receiving medication.

Interventions

Zepbound DRUG

Auto injectors with a 2.5 mg dosage are given subcutaneously weekly.

Also known as: Tirzepatide

Tirzepatide

Eligibility Criteria

• Age: 55 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 55-70 years
• BMI ≥ 30 kg/m² or ≥ 27 kg/m² if also with ≥ 1 weight-related comorbidity
• If taking anti-inflammatory or blood-pressure-/lipid-/glucose-lowering medications, no change in dose for ≥12 weeks prior to entry and no plans to dose escalate for the study duration
• Willing and able to provide written informed consent and undergo all required study procedures

You may not qualify if:

• BMI \>35 kg/m²
• Uncontrolled or end-stage, comorbid, cardiometabolic disease, in the opinion of the site investigator
• Significant neurocognitive impairment, in the opinion of the site investigator
• Current or planned use of medications for the treatment of obesity, or medications likely to cause significant changes in weight, during the study period (see prohibited medications, section 6.0)
• Use of insulin
• Plans to newly engage in formal, intensive physical activity or diet (such as ketogenic or very low carbohydrate) programs during the study period
• Active eating disorder
• Use of human growth hormone, tesamorelin, supraphysiologic testosterone or estradiol (stable doses for contraception, hypogonadism or other indications for exogenous sex steroid replacement therapy permitted) or anabolic steroids \<12 W prior to entry, unless on a stable dose for \>24 W prior to entry, or plans to start any of these medications while on study
• Active, severe delayed gastric emptying
• Prior bariatric surgery or major gastric surgery or plans for weight reduction surgery while on study
• Known diabetic retinopathy
• Personal or first-degree relative history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2
• Untreated, poorly controlled or previously undiagnosed thyroid disease
• History of chronic pancreatitis
• History of suicidal attempts or active suicidal ideation, in the opinion of the site investigator

Sponsors & Collaborators

• The University of Texas Medical Branch, Galveston: lead

Study Sites (1)

University of Texas Medical Branch

Galveston, Texas, 77555, United States

RECRUITING

MeSH Terms

Interventions

Tirzepatide

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide-1 Receptor; Glucagon-Like Peptide Receptors; Receptors, G-Protein-Coupled; Receptors, Cell Surface; Membrane Proteins; Proteins; Amino Acids, Peptides, and Proteins; Receptors, Gastrointestinal Hormone; Receptors, Peptide

Study Officials

• Thomas Blackwell, MD, FACP

  University of Texas Medical Branch, Galveston

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lamonne Crutcher

CONTACT

(409)772-1619; lmcrutch@utmb.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2025
• First Posted: October 24, 2025
• Study Start: February 27, 2026
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: March 24, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)