ALT-801 for Obesity

No longer recruiting at 31 trial locations

Overseen By Altimmune CTM

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Altimmune, Inc.

Disqualifiers: Diabetes, Bariatric surgery, Pancreatitis, others

Stay on Your Current Meds You can continue your current medications while participating

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

Compensation: Varies

Number of Visits: Unknown

Duration: 48 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment, ALT-801, to determine its effectiveness in promoting weight loss for individuals with obesity or those who are overweight. Participants will receive either ALT-801 or a placebo, alongside a plan to reduce calorie intake and increase physical activity. The trial aims to assess the safety and effectiveness of ALT-801 when combined with lifestyle changes. It seeks participants with a BMI of 30 or more, or a BMI of 27 or more with an obesity-related condition, who have unsuccessfully tried to lose weight. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant advancements in obesity treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, it is important to discuss your medications with the study team to ensure they align with the trial's requirements.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that ALT-801, also known as pemvidutide, has been tested for safety and effectiveness. In earlier studies, ongoing treatment with pemvidutide improved liver health and aided weight loss, indicating that the treatment works as expected without causing major health issues.

One study found that ALT-801 led to a 5.4% weight loss after just six weeks, a positive sign for weight management. Importantly, the study also checked for safety and found no serious problems related to the treatment, reassuring those considering joining a trial.

Overall, ALT-801 appears well-tolerated, with no reports of severe side effects in these early studies. While more research is needed to confirm these results, the current findings are promising for those interested in participating in a trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for obesity?

Researchers are excited about ALT-801 for obesity because it offers a unique approach compared to current treatments like lifestyle changes, medications such as orlistat, or GLP-1 receptor agonists like liraglutide. ALT-801 is a novel dual GLP-1/glucagon receptor agonist, which means it targets both the GLP-1 and glucagon receptors, potentially enhancing weight loss and metabolic benefits. This dual action could lead to more effective weight reduction and improved metabolic health outcomes. Additionally, the design of ALT-801 aims to reduce common side effects associated with existing GLP-1 therapies, making it a promising candidate for those struggling with obesity.

What evidence suggests that this trial's treatments could be effective for obesity?

Research has shown that ALT-801 may aid in weight loss. In a previous study, participants taking ALT-801 once a week lost 5.4% of their body weight in just six weeks. ALT-801 targets two specific areas in the body, reducing liver fat and aiding weight loss. Another study found that ALT-801 also lowered signs of inflammation and tissue scarring. In this trial, participants will receive different doses of ALT-801 or a placebo. These findings suggest that ALT-801 could be effective for weight loss when combined with a low-calorie diet and increased physical activity. ^{4 5 6 7 8}

Who Is on the Research Team?

Sarah K Browne, MD

Principal Investigator

Altimmune, Inc.

Are You a Good Fit for This Trial?

Inclusion Criteria

At least one unsuccessful weight loss attempt per investigator judgement

Written informed consent signed prior to entry into the study

Body mass index (BMI) ≥ 30 kg/m2 or BMI ≥ 27 kg/m2 combined with at least one obesity-related comorbidity

Exclusion Criteria

HbA1c > 6.5%, fasting glucose ≥ 126 mg/dL (6.9 mmol/L), and/or random glucose of ≥ 200 mg/dL (11.0mmol/L) at screening

History of acute or chronic pancreatitis within 1 year (365 days) before screening

History of GI surgery, including cholecystectomy and antrectomy. Surgery for appendicitis and small bowel resection >20cm is acceptable.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive ALT-801 or placebo once-weekly as an adjunct to a reduced-calorie diet and increased physical activity

48 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• ALT-801
• Placebo
• Reduced-calorie diet and increased physical activity

How Is the Trial Designed?

Group I: ALT-801 Dose Level 3 Experimental Treatment 1 Intervention

Group II: ALT-801 Dose Level 2 Experimental Treatment 1 Intervention

Group III: ALT-801 Dose Level 1 Experimental Treatment 1 Intervention

Group IV: Placebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Altimmune, Inc.

Lead Sponsor

Trials

17

Recruited

1,500+

Published Research Related to This Trial

In a 1-year randomized controlled trial involving 80 individuals with type 2 diabetes, neither moderate-intensity continuous training (MICT) nor high-intensity interval training (HIIT) led to compensatory changes in non-exercise physical activity (NEPA) or estimated thermogenesis (NEAT) on non-training days.

Participants who were classified as low-responders or high-responders in terms of body weight and fat mass reductions did not show significant differences in NEPA or NEAT compared to control groups, indicating that exercise intensity did not affect these non-training day activities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Compensatory mechanisms from different exercise intensities in type 2 diabetes: a secondary analysis of a 1-year randomized controlled trial. Correia, IR., Hetherington-Rauth, M., Magalhães, JP., et al.[2023]

In a study involving 172 women undergoing chemotherapy, intermittent energy restriction (IER) showed a trend towards greater weight and body fat reduction compared to continuous energy restriction (CER), particularly after adjusting for body water.

While the overall incidence of severe chemotherapy toxicities was similar between IER and CER, there was a trend indicating fewer severe toxicities in the IER group during later cycles of treatment, suggesting IER may help reduce treatment-related side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomised controlled trial of intermittent vs continuous energy restriction during chemotherapy for early breast cancer. Harvie, M., Pegington, M., Howell, SJ., et al.[2022]

In a study of 44 patients with obesity, a Very Low Calorie Diet (VLCD) resulted in an average weight loss of 7 kg and a weight loss rate of 1.2 kg per week, indicating its effectiveness for weight management.

While 33% of participants reported mild side effects, such as constipation and dizziness, the majority (84%) adhered to the VLCD, suggesting that with proper support, adherence can be maintained.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Effectiveness and safety of Very Low Calory Diets in obese patients]. Sáez Belló, M., Segarra Villalba, C., Gras Colomer, E., et al.[2018]

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/39002641/

Effect of pemvidutide, a GLP-1/glucagon dual receptor ...

This study demonstrated the ability of once-weekly treatment with pemvidutide, a dual GLP-1R/glucagon receptor agonist, to significantly reduce liver fat ...

2.

ir.altimmune.com

ir.altimmune.com/news-releases/news-release-details/altimmune-announces-positive-interim-data-alt-801-phase-1-trial

Altimmune Announces Positive Interim Data from ALT-801 ...

The interim data showed a mean weight loss of 5.4% was achieved by Week 6 with a once weekly ALT-801 dose of 1.8 mg administered subcutaneously (sc)

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05295875

Efficacy and Safety of ALT-801 in the Treatment of Obesity

This study will evaluate the efficacy and safety of ALT-801 once-weekly versus placebo as an adjunct to a reduced-calorie diet and increased physical activity ...

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9035150/

Effects of ALT-801, a GLP-1 and glucagon receptor dual ...

Low and high dose treatment with ALT-801 resulted in a significant reduction in the inflammation marker Gal-3 and the fibrosis marker Col1A1 (Fig. 5). All data ...

5.

sciencedirect.com

sciencedirect.com/science/article/pii/S2589555925001612

Safety and efficacy of 24 weeks of pemvidutide in ...

24 weeks of pemvidutide treatment resulted in significant reductions in liver fat content and body weight that further improved upon the effects observed at 12 ...

6.

file.medchemexpress.com

file.medchemexpress.com/batch_PDF/HY-145632A/Pemvidutide-TFA-SDS-MedChemExpress.pdf

Pemvidutide TFA-SDS-MedChemExpress

OSHA: No component of this product present at a level equal to or greater than 0.1% is identified as a potential or confirmed carcinogen by OSHA ...

7.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/41113119/?utm_source=FeedFetcher&utm_medium=rss&utm_campaign=None&utm_content=1Jgu41lFGSj_ShZE4NRQ2hnLFGqOVFuKpoCzfmgi2UmEsRik-&fc=None&ff=20251027222541&v=2.18.0.post22+67771e2

Safety and efficacy of 24 weeks of pemvidutide in ...

The current trial demonstrates that continued treatment with pemvidutide further improves these clinical markers of MASH. Clinical trials ...

8.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05006885

Study Details | NCT05006885 | ALT-801 in Diabetic and ...

The purpose of the study is to assess the safety and tolerability of ALT-801 in diabetic and non-diabetic subjects with overweight and obese and non-alcoholic ...