CompletedPhase 1

Study to Evaluate the Pharmacodynamic Effects of a Single Oral Dose of GS-0976 (NDI-010976) in Healthy Adult Subjects

United States30 participantsStarted 2015-08

Plain-language summary

The primary objective of this study is to assess the pharmacodynamic (PD) effects of GS-0976 (NDI-010976) on fractional de novo lipogenesis (DNL) following a single oral dose administration in overweight and/or obese, but otherwise healthy, male adults.

Who can participate

Age range

18 Years – 50 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Overweight and/or obese, but otherwise healthy males * Weight ≥ 50.0 kg * Body Mass Index (BMI): 25.0 - 32.0 kg/m\^2, inclusive Exclusion Criteria: * Intolerance to or malabsorption of fructose * A history of clinically significant gastrointestinal disease and/or surgery, which would result in the subject's inability to absorb or metabolize the study drug (e.g., gastrectomy, gastric bypass, cholecystectomy). * In the opinion of the Investigator, a history of clinically significant hematologic, renal, hepatic, bronchopulmonary, neurological, psychiatric, metabolic , endocrine disorder (e.g., diabetes, thyroid disease), or cardiovascular disease.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in fractional DNL (% new palmitate)

Timeframe: Predose and up to 10 hours postdose

Change in DNL over time following administration of GS-0976 and placebo

Timeframe: Predose and up to 10 hours postdose

Change from baseline over time in adiponectin

Timeframe: Baseline and up to 10 hours postdose

Percent change from baseline over time in adiponectin

Timeframe: Baseline and up to 10 hours postdose

Change from baseline over time in leptin

Timeframe: Baseline and up to 10 hours postdose

Percent change from baseline over time in leptin

Timeframe: Baseline and up to 10 hours postdose

Change from baseline over time in blood ketones

Timeframe: Baseline and up to 10 hours postdose

Trial details

NCT IDNCT02876796

SponsorGilead Sciences

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2015-09

View on ClinicalTrials.gov More PD Effects of GS-0976 (NDI-010976) on Fractional DNL trials

Who can participate

Age range

18 Years – 50 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change in fractional DNL (% new palmitate)

Timeframe: Predose and up to 10 hours postdose

Change in DNL over time following administration of GS-0976 and placebo

Timeframe: Predose and up to 10 hours postdose

Change from baseline over time in adiponectin

Timeframe: Baseline and up to 10 hours postdose

Percent change from baseline over time in adiponectin

Timeframe: Baseline and up to 10 hours postdose

Change from baseline over time in leptin

Timeframe: Baseline and up to 10 hours postdose

Percent change from baseline over time in leptin

Timeframe: Baseline and up to 10 hours postdose

Change from baseline over time in blood ketones

Timeframe: Baseline and up to 10 hours postdose