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NCT Number: NCT07473713

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

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

Recruiting

Interested in participating?

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location status: Recruiting

Location contact

Elise Danico

CONTACT

[email protected]

617-636-3273

Lisa Ceglia, MD MS

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Community dwelling adults age 50 years and older (approximately equal numbers of men and women).
  • Men should be sterile or agree to use contraception throughout the study.
  • 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).
  • 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.
  • On a prescreening interview, candidates must report a usual diet associated with an acid load by our validated short questionnaire.
  • Estimated glomerular filtration rate (eGFR) must be 45 ml/min or greater.
  • Participants must agree not to change their exercise pattern or medication use during the study.
  • 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.
  • Participants must agree to not change their eating habits or intentionally change their weight.

Exclusion criteria

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

Treatment and study plan

veverimer daily

Drug

8 weeks of taking 9 grams of veverimer (a powder mixed into water) daily

veverimer every other day

Drug

8 weeks of taking 9 grams of veverimer (a powder mixed into water) every other day

Placebo

Other

8 weeks taking 9 grams microcrystalline cellulose (powdered mixed into water) daily or every other day

Primary outcomes

  1. 24-hr urinary net acid excretion

    Time frame: measured at screening, week 2, week 8 and week 8 +1day

Secondary outcomes

  1. Serum bicarbonate level

    Time frame: measured at screening, week 0, week 1, week 2, week 4, week 8

  2. Serum potassium level

    Time frame: measured at screening, week 0, week 1, week 2, week 4, week 8

  3. Serum C-telopeptide level

    Time frame: measured at week 0, week 2, week 8

  4. Serum procollagen type 1 N-propeptide level

    Time frame: measured at week 0 and week 8

Other outcomes

  1. 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

  2. Gait speed

    Time frame: measured at week 0 and week 8

    6-meter walking speed with higher time indicating lower function

  3. 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

  4. 24-hr urinary pH

    Time frame: measured at screening, week 2, week 8, and week 8 +1day

  5. 24-hr urinary creatinine

    Time frame: measured at screening, week 2, week 8, and week 8 +1day

Study contacts

Contact information is provided by the study sponsor or research team.

Elise Danico, MS

CONTACT

[email protected]

617-636-3232

Sponsors and collaborators

Lead sponsor

Tufts Medical Center

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Mar 16, 2026
Registry last updated
Apr 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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