TERN-601 for Obesity

(FALCON Trial)

Recruiting at 18 trial locations

Overseen By Study Director

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Terns, Inc.

Disqualifiers: Diabetes, Endocrinologic disorders, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

150 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators for more details.

What safety data exists for TERN-601 or similar anti-obesity treatments?

There is no specific safety data available for TERN-601, but other anti-obesity medications have been linked to serious side effects like heart and kidney problems, nausea, and dizziness. It's important to monitor these treatments closely for safety. ^{1 2 3 4 5}

What is the purpose of this trial?

This is a Phase 2a multicenter, randomized, double-blind, placebo-controlled clinical trial studying the efficacy, safety, and tolerability of orally administered TERN-601 in adults with overweight or obesity.

Eligibility Criteria

Adults with overweight or obesity are eligible for this trial. Specific health conditions and other criteria will be assessed to determine eligibility, but these details are not provided in the summary.

Inclusion Criteria

My BMI is between 27 and <50, with a weight-related health issue if it's 27-<30.

HbA1c < 6.5%

Stable self-reported body weight for at least 3 months prior to study (< 5% body weight gain or loss)

Exclusion Criteria

My obesity is caused by medication or a hormone disorder.

Lifetime history of suicide attempt

Have diabetes mellitus

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive TERN-601 or placebo orally once daily for 12 weeks

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• TERN-601

Trial Overview The study is testing TERN-601, an oral medication, against a placebo (a pill without active ingredients) to see if it's effective and safe for treating adults with overweight or obesity.

Participant Groups

Group I: TERN-601 Dose 4 Experimental Treatment 1 Intervention

Orally administered once daily.

Group II: TERN-601 Dose 3 Experimental Treatment 1 Intervention

Orally administered once daily.

Group III: TERN-601 Dose 2 Experimental Treatment 1 Intervention

Orally administered once daily.

Group IV: TERN-601 Dose 1 Experimental Treatment 1 Intervention

Orally administered once daily.

Group V: Matching Placebo Placebo Group 1 Intervention

Orally administered once daily.

Who Is Running the Clinical Trial?

Terns, Inc.

Lead Sponsor

Trials

5

Recruited

570+

Findings from Research

A comprehensive analysis of the FDA Adverse Event Reporting System revealed 18,675 unique adverse event reports linked to anti-obesity medications (AOMs) among 15,143 patients, highlighting significant safety concerns.

Serious adverse events included a fatality ratio of 4.9%, with cardiovascular complications being particularly prevalent, accounting for 31% of AEs related to phentermine, and indicating a need for ongoing safety monitoring of AOMs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Descriptive analysis of reported adverse events associated with anti-obesity medications using FDA Adverse Event Reporting System (FAERS) databases 2013-2020. Alsuhibani, A., Alrasheed, M., Gari, M., et al.[2022]

A total of 25 anti-obesity medications were withdrawn between 1964 and 2009, primarily due to adverse reactions related to their effects on monoamine neurotransmitters, with 80% of withdrawals supported by case reports.

The most common reasons for withdrawal included psychiatric disturbances, cardiotoxicity, and drug dependence, raising concerns about the safety of using medications that target neurotransmitters for obesity management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Post-marketing withdrawal of anti-obesity medicinal products because of adverse drug reactions: a systematic review. Onakpoya, IJ., Heneghan, CJ., Aronson, JK.[2022]

Three FDA-approved medications for long-term obesity treatment—sibutramine, orlistat, and rimonabant—have shown significant weight loss benefits in large clinical trials lasting 2 to 4 years, with average weight loss of 8%-10% compared to 4%-6% for placebo.

While all medications have side effects, sibutramine can increase blood pressure and heart rate, orlistat can cause gastrointestinal issues like steatorrhea, and rimonabant generally has a favorable safety profile with mild, self-limited nausea and gastrointestinal symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Drug treatment of the overweight patient. Bray, GA., Ryan, DH.[2018]

A total of 4941 adverse event (AE) reports were identified for antiobesity medicines in Europe from 2007 to 2014, with over 90% classified as serious, including 159 deaths, highlighting significant safety concerns associated with these medications.

The most commonly reported serious AEs were cardiac (19%) and psychiatric disorders (18%), particularly linked to orlistat and rimonabant, indicating a need for ongoing safety monitoring despite the withdrawal of some products from the market.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Serious adverse events reported for antiobesity medicines: postmarketing experiences from the EU adverse event reporting system EudraVigilance. Aagaard, L., Hallgreen, CE., Hansen, EH.[2018]

Current antiobesity drugs in Phase II clinical trials show promise, but many have faced challenges with safety and efficacy, highlighting the need for better options.

Future weight loss treatments may focus on personalized approaches for specific groups and could involve fixed-dose combinations targeting multiple pathways to achieve significant and sustainable weight loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Investigational drugs in Phase II clinical trials for the treatment of obesity: implications for future development of novel therapies. Jackson, VM., Price, DA., Carpino, PA.[2014]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Descriptive analysis of reported adverse events associated with anti-obesity medications using FDA Adverse Event Reporting System (FAERS) databases 2013-2020. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Post-marketing withdrawal of anti-obesity medicinal products because of adverse drug reactions: a systematic review. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Drug treatment of the overweight patient. [2018]

4. England pubmed.ncbi.nlm.nih.gov

Serious adverse events reported for antiobesity medicines: postmarketing experiences from the EU adverse event reporting system EudraVigilance. [2018]

5. England pubmed.ncbi.nlm.nih.gov

Investigational drugs in Phase II clinical trials for the treatment of obesity: implications for future development of novel therapies. [2014]