Veverimer to Decrease Net Acid Excretion and Bone Resorption in Adults With Osteopenia

March 31, 2026 updated by: Tufts Medical Center

Veverimer to Decrease Net Acid Excretion and Bone Resorption in Adults With Osteopenia: a Dose-finding Randomized Controlled Trial

The goal of this clinical trial is to learn if veverimer will reduce urinary net acid excretion leading to reduced bone resorption in healthy adults with osteopenia. The main questions it aims to answer are:

  • How much does each dose of veverimer (vs. placebo) reduce 24-hr urinary net acid excretion.
  • Describe the safety of veverimer based on changes in serum bicarbonate and potassium.
  • Assess the changes in bone resorption.
  • Assess the changes in bone formation.
  • Explore the effect of veverimer on physical performance.

Participants will:

  • Take veverimer or placebo every day or every other day for 8 weeks
  • Visit the clinic a total of 8 times (including screening) for checkups and testing
  • Keep a medication diary tracking each day they take the study drug

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Recruiting
        • Tufts Medical Center
        • Contact:
        • Principal Investigator:
          • Lisa Ceglia, MD MS

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Community dwelling adults age 50 years and older (approximately equal numbers of men and women).
  2. Men should be sterile or agree to use contraception throughout the study.
  3. Women must be postmenopausal, defined as no menses in the last 5 years (to reduce variability in change in bone resorption since menopause prompts a rapid increase in bone resorption).
  4. Osteopenia will be defined as a bone mineral density (BMD) T-score at the lumbar spine, femoral neck, or total hip lower than -1 or higher than -2.5.
  5. On a prescreening interview, candidates must report a usual diet associated with an acid load by our validated short questionnaire.
  6. Estimated glomerular filtration rate (eGFR) must be 45 ml/min or greater.
  7. Participants must agree not to change their exercise pattern or medication use during the study.
  8. Participants must agree not to change their pattern of supplement use and not to use antacids during the study because most calcium supplements and other antacids add alkali.
  9. Participants must agree to not change their eating habits or intentionally change their weight.

Exclusion Criteria:

  1. Normal BMD T-scores at all spine and hip sites, osteoporosis based on BMD T-score of -2.5 or less
  2. Respiratory illness in last month
  3. Chronic obstructive pulmonary disease (COPD)
  4. Asthma
  5. Nausea/vomiting in last month
  6. Dysphagia
  7. Malabsorption
  8. Inflammatory bowel disease
  9. Chronic diarrhea (defined as loose bowel movements daily) or constipation (≤ 2 stools per week)
  10. Insulin-requiring diabetes or fasting plasma glucose >125 mg/dl
  11. Untreated thyroid disease
  12. Cirrhosis
  13. Current unstable heart disease
  14. Malignancy (except non-melanoma skin cancer) or cancer therapy in last year
  15. Alcohol use >2 drinks/day.
  16. Individuals who are unable to provide informed consent due to cognitive impairment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Veverimer 9 g/day
Drug: veverimer daily
8 weeks of taking 9 grams of veverimer (a powder mixed into water) daily
Experimental: Veverimer 9 g/every other day
Drug: veverimer every other day
8 weeks of taking 9 grams of veverimer (a powder mixed into water) every other day
Placebo Comparator: Placebo (microcrystalline cellulose with 0.075% yellow ferric oxide)
Other: Placebo
8 weeks taking 9 grams microcrystalline cellulose (powdered mixed into water) daily or every other day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
24-hr urinary net acid excretion
Time Frame: measured at screening, week 2, week 8 and week 8 +1day
measured at screening, week 2, week 8 and week 8 +1day

Secondary Outcome Measures

Outcome Measure
Time Frame
Serum bicarbonate level
Time Frame: measured at screening, week 0, week 1, week 2, week 4, week 8
measured at screening, week 0, week 1, week 2, week 4, week 8
Serum potassium level
Time Frame: measured at screening, week 0, week 1, week 2, week 4, week 8
measured at screening, week 0, week 1, week 2, week 4, week 8
Serum C-telopeptide level
Time Frame: measured at week 0, week 2, week 8
measured at week 0, week 2, week 8
Serum procollagen type 1 N-propeptide level
Time Frame: measured at week 0 and week 8
measured at week 0 and week 8

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
24-hr urinary pH
Time Frame: measured at screening, week 2, week 8, and week 8 +1day
measured at screening, week 2, week 8, and week 8 +1day
24-hr urinary creatinine
Time Frame: measured at screening, week 2, week 8, and week 8 +1day
measured at screening, week 2, week 8, and week 8 +1day
Sit-to-stand time
Time Frame: measured at week 0 and week 8
Sit-to-stand time with higher times indicating lower strength and function
measured at week 0 and week 8
Gait speed
Time Frame: measured at week 0 and week 8
6-meter walking speed with higher time indicating lower function
measured at week 0 and week 8
Time-up-and-go time
Time Frame: measured at week 0 and week 8
time-up-and-go with 3 meter walk with higher time indicating lower function
measured at week 0 and week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tufts Medical Center

Collaborators

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 Major Dates

Study Start (Estimated)

April 15, 2026

Primary Completion (Estimated)

March 1, 2028

Study Completion (Estimated)

May 1, 2028

Study Registration Dates

First Submitted

March 10, 2026

First Submitted That Met QC Criteria

March 10, 2026

First Posted (Actual)

March 16, 2026

Study Record Updates

Last Update Posted (Actual)

April 6, 2026

Last Update Submitted That Met QC Criteria

March 31, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00006557
  • 1R61AR085647-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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