A 24-week randomized Phase 2 obesity trial reported dose-related weight loss versus placebo.
This is the strongest human-evidence boundary in the current record.
Gathering the record
Relay is organizing the evidence and source boundaries.
Monoamine reuptake-inhibitor small molecule
An experimental weight-loss pill that changes brain signals involved in appetite.
Evidence is explained by question. Dosing references show their own check dates.
60-second overview
Why people look into it, what studies found, and what is still unknown.
Educational information only. Evidence reviewed through July 31, 2026. Published studies, sponsor announcements, and trials without results are labeled separately. Evidence gaps apply to the specific finding beside them.
Research questions
Each label shows how much evidence supports that question.
What studies show
A 24-week randomized Phase 2 obesity trial reported dose-related weight loss versus placebo.
This is the strongest human-evidence boundary in the current record.
Mechanistic findings explain biological plausibility; they do not establish a human outcome.
Relay keeps this uncertainty visible rather than converting it into a prediction.
The safety snapshot reflects the studied record and its limitations.
Regulatory and identity status determine how the evidence should be interpreted.
Risks & unknowns
Trials report dry mouth, nausea, constipation, sleep disturbance, and increased heart rate in some groups; longer-term cardiovascular and neuropsychiatric safety remains central.
Controlled human evidenceReported events depend on population, formulation, route, exposure, comparator, and study size.
Open sourceThe available information does not reliably show how often particular side effects occur.
Evidence boundaryUnder-detected or under-reported events must not be described as rare.
Relay has not verified which side effects led people to stop treatment in studies.
Evidence boundaryThis is an evidence gap, not proof that discontinuations did not occur.
Relay has not verified a compound-specific warning summary for this profile.
Evidence boundaryInvestigational; no FDA-approved tesofensine product. Whether longer-term benefits outweigh cardiovascular, neuropsychiatric, sleep, and misuse-related risks in larger diverse populations.
This profile does not contain verified, product-specific emergency instructions.
Evidence boundaryRelay does not infer emergency guidance from study discontinuations, mechanism, or incomplete adverse-event reporting.
Dosing references
Each table labels its source and applies only to the named route, product, or study. An online example or community report is not an approved dose.
Amounts reported in a human study. A studied amount is not automatically an approved dose or a recommendation for an individual.
A randomized obesity trial studied 203 adults alongside an energy-restricted diet.
| Stage / period | Amount in source | Frequency |
|---|---|---|
| 24 weeks | 0.25, 0.5, or 1 mg groups | Once daily |
These were separate randomized groups, not an escalation sequence. The trial does not establish a dose for injected products or combination fat-loss blends.
Tesofensine · randomized Phase 2 obesity trial Primary article · Methods / interventionThis reference checked Oct 20, 2026. The full-profile review date is shown at the top.The study used oral medication. It does not establish a mixing recipe or injected formulation.
Starting dose: the amount used at the beginning of the named label schedule or trial.
Maintenance: the ongoing amount described by that product label.
Trial target: the amount assigned to a study group. Different groups may stop increasing at different targets.
A published Phase 2 trial investigated oral tesofensine in adults with obesity, focusing on weight, body composition, quality of life, and tolerability.
Population: Adults with obesity
Design: Randomized double-blind placebo-controlled trial
Mechanisms
A Phase 2 obesity trial reported substantial weight loss over 24 weeks, alongside pulse and other tolerability findings. Later combination research does not make tesofensine monotherapy approved or broadly established.
A plausible mechanism can explain why a study was attempted. It does not prove that the compound improves a human outcome.
Research reference
A reference for the studies, populations, and routes behind this profile.
Controlled human obesity evidence with cardiovascular, neuropsychiatric, and long-term outcome questions.
Research depth describes how large and mature the overall record is. It does not tell you whether the results were positive.
Whether longer-term benefits outweigh cardiovascular, neuropsychiatric, sleep, and misuse-related risks in larger diverse populations.
Confidence describes how reliable and consistent the conclusions are. It can be high for one outcome and low for another.
The strongest evidence type shows what the best-supported conclusions are actually based on.
Human findings are more directly relevant than animal or laboratory results, but they still apply only to the populations and outcomes studied.
Route-specific record
These are exposures used in cited research for a specific route and population—not an instruction for an individual.
Half-life describes how long it takes the measured amount in the body to fall by half. It is not a dosing recommendation.
Evidence can change by administration method. Findings from one route should not automatically be applied to another.
Evidence boundary: The study lasted 24 weeks and cannot resolve long-term cardiovascular, sleep, mood, or misuse-related outcomes. Later combination research cannot be assigned to tesofensine alone or converted into an approved regimen. Amounts shown describe cited research exposure—not a dosage recommendation.
Studies
Study arms are reported for transparency. They describe what researchers did in a defined record and do not transfer across identities, routes, formulations, or populations.
A later trial phase can ask a more mature question, but it does not guarantee a positive result, regulatory approval, or relevance outside the studied population.
Randomized double-blind placebo-controlled trial
Adults with obesity
In a 24-week Phase 2 trial, tesofensine produced dose-related weight loss greater than placebo.
Study administration: Multiple oral tesofensine doses versus placebo
Limitations: Phase 2 size and duration; pulse and tolerability findings require longer outcome research.
Randomized crossover human abuse-potential study
Recreational stimulant users
Endpoints were not fully described in the current record.
A controlled study evaluated subjective and pharmacologic effects relevant to misuse potential.
Study administration: Not stated in the current record.
Limitations: Acute specialized design does not establish longer-term misuse risk.
Randomized placebo-controlled trial
Adults with hypothalamic obesity
Endpoints were not fully described in the current record.
Combination research explored tesofensine plus metoprolol in a rare hypothalamic-obesity population.
Study administration: Not stated in the current record.
Limitations: Combination and rare-disease evidence cannot be attributed to tesofensine alone.
Community
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PMID 18950853
PMID 20520602
PMID 35294397